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1,652 results on '"Settore MED/10 - Malattie dell'Apparato Respiratorio"'

201. Large Cell Neuro-Endocrine Carcinoma of the Lung: Current Treatment Options and Potential Future Opportunities

Author: Ferrara, Miriam Grazia, Stefani, Alessio, Simbolo, Michele, Pilotto, Sara, Martini, Maurizio, Lococo, Filippo, Vita, Emanuele, Chiappetta, Marco, Cancellieri, Alessandra, D'Argento, Ettore, Trisolini, Rocco, Rindi, Guido, Scarpa, Aldo, Margaritora, Stefano, Milella, Michele, Tortora, Giampaolo, Bria, Emilio, Martini, Maurizio (ORCID:0000-0002-6260-6310), Lococo, Filippo (ORCID:0000-0002-9383-5554), Rindi, Guido (ORCID:0000-0003-2996-4404), Margaritora, Stefano (ORCID:0000-0002-9796-760X), Tortora, Giampaolo (ORCID:0000-0002-1378-4962), Bria, Emilio (ORCID:0000-0002-2333-704X), Ferrara, Miriam Grazia, Stefani, Alessio, Simbolo, Michele, Pilotto, Sara, Martini, Maurizio, Lococo, Filippo, Vita, Emanuele, Chiappetta, Marco, Cancellieri, Alessandra, D'Argento, Ettore, Trisolini, Rocco, Rindi, Guido, Scarpa, Aldo, Margaritora, Stefano, Milella, Michele, Tortora, Giampaolo, Bria, Emilio, Martini, Maurizio (ORCID:0000-0002-6260-6310), Lococo, Filippo (ORCID:0000-0002-9383-5554), Rindi, Guido (ORCID:0000-0003-2996-4404), Margaritora, Stefano (ORCID:0000-0002-9796-760X), Tortora, Giampaolo (ORCID:0000-0002-1378-4962), and Bria, Emilio (ORCID:0000-0002-2333-704X)
Abstract: Large-cell neuroendocrine carcinomas of the lung (LCNECs) are rare tumors representing 1-3% of all primary lung cancers. Patients with LCNEC are predominantly male, older, and heavy smokers. Histologically, these tumors are characterized by large cells with abundant cytoplasm, high mitotic rate, and neuroendocrine immunohistochemistry-detected markers (chromogranin-A, synaptophysin, and CD56). In 2015 the World Health Organization classified LCNEC as a distinct subtype of pulmonary large-cell carcinoma and, therefore, as a subtype of non-small cell lung carcinoma (NSCLC). Because of the small-sized tissue samples and the likeness to other neuroendocrine tumors, the histological diagnosis of LCNEC remains difficult. Clinically, the prognosis of metastatic LCNECs is poor, with high rates of recurrence after surgery alone and overall survival of approximately 35% at 5 years, even for patients with early stage disease that is dramatically shorter compared with other NSCLC subtypes. First-line treatment options have been largely discussed but with limited data based on phase II studies with small sample sizes, and there are no second-line well defined treatments. To date, no standard treatment regimen has been developed, and how to treat LCNEC is still on debate. In the immunotherapy and targeted therapy era, in which NSCLC treatment strategies have been radically reshaped, a few data are available regarding these opportunities in LCNEC. Due to lack of knowledge in this field, many efforts have been done for a deeper understanding of the biological and molecular characteristics of LCNEC. Next generation sequencing analyses have identified subtypes of LCNEC that may be relevant for prognosis and response to therapy, but further studies are needed to better define the clinical impact of these results. Moreover, scarce data exist about PD-L1 expression in LCNEC and its predictive value in this histotype with regard to immunotherapy efficacy. In the literature some cases are
Published: 2021

202. Finding an Evidence-Based and Clinically Important Role for BAL in the Setting of Suspected SARS-Cov-2 Infection

Author: Trisolini, Rocco, Bello, Giuseppe, Antonelli, Massimo, Bello, Giuseppe (ORCID:0000-0003-2648-7235), Antonelli, Massimo (ORCID:0000-0003-3007-1670), Trisolini, Rocco, Bello, Giuseppe, Antonelli, Massimo, Bello, Giuseppe (ORCID:0000-0003-2648-7235), and Antonelli, Massimo (ORCID:0000-0003-3007-1670)
Published: 2021

203. Accuracy and Reproducibility of Endoscopic Ultrasound B-Mode Features for Observer-Based Lymph Nodal Malignancy Prediction

Author: Verhoeven, Roel L J, Leoncini, Fausto, Slotman, Jorik, de Korte, Chri, Trisolini, Rocco, van der Heijden, Erik H F M, Verhoeven, Roel L J, Leoncini, Fausto, Slotman, Jorik, de Korte, Chri, Trisolini, Rocco, and van der Heijden, Erik H F M
Abstract: Background: Endoscopic ultrasound routinely guides lymph node evaluation for the staging of a known or suspected lung cancer. Characteristics seen on B-mode imaging might help the observer decide on the lymph nodes of risk. The influence of nodal size on the predictivity of these characteristics and the agreement with which operators can combine these for malignancy risk prediction is to be determined. Objectives: We evaluated (1) if prospectively scored individual B-mode ultrasound features predict malignancy when further divided by size and (2) assessed if observers were able to reproducibly agree on still lymph node image malignancy risk. Methods: Lymph nodes as visualized by EBUS were prospectively scored for B-mode characteristics. Still B-mode images were furthermore collected. After collection, a repeated scoring of a subset of lymph nodes was retrospectively performed (n = 11 observers). Results: Analysis of 490 lymph nodes revealed the short axis size is an objective measure for stratifying risk of malignancy (ROC area under the curve 0.78). With >= 8-mm size, 210/237 malignant lymph nodes were correctly identified (89% sensitivity, 46% specificity, 61% PPV, and 81% NPV). Secondary addition of B-mode features in Conclusions: Lymph nodes of >= 8-mm size and preferably even smaller should be aspirated regardless of other B-mode features. Observer disagreement in scoring both small and large lymph nodes suggests it is infeasible to include subjective features for stratification. Future research should focus on (integrating) other (semi)quantitative values for improving prediction.
Published: 2021

204. Endobronchial ultrasound in diagnosing and staging of lung cancer by Acquire 22G TBNB versus regular 22G TBNA needles: study protocol of a randomised clinical trial

Author: Kuijvenhoven, Jolanda C, Kramer, Te, Korevaar, Daniël A, Ninaber, Maarten K, Trisolini, Rocco, Szlubowski, Artur, Gnass, Maciej, von der Thüsen, Jan, Cohen, Danielle, Bonta, Peter I, Annema, Jouke T, Kuijvenhoven, Jolanda C, Kramer, Te, Korevaar, Daniël A, Ninaber, Maarten K, Trisolini, Rocco, Szlubowski, Artur, Gnass, Maciej, von der Thüsen, Jan, Cohen, Danielle, Bonta, Peter I, and Annema, Jouke T
Abstract: Introduction Accurate diagnosis and staging of lung cancer is crucial because it directs treatment and prognosis. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound with bronchoscope fine-needle aspiration (EUS-B-FNA) are important in this process by sampling hilar/mediastinal lymph nodes and centrally located lung tumours. With the upcoming of immunotherapy and targeted therapies, assessment of programmed death ligand 1 (PD-L1) expression and molecular profiling has become important but is often impossible in cytological samples obtained through standard 22G TBNA needles. Recently, a three-pronged cutting edge 22G needle was developed that allows for transbronchial needle biopsy (TBNB). Our objective is to determine if EBUS/EUS-B-guided nodal/lung tumour sampling with Acquire 22G TBNB needles results in an improved suitability rate for the assessment of PD-L1 expression in comparison to standard 22G TBNA needles in patients with a final diagnosis of lung cancer. Methods and analysis This is an investigator-initiated, parallel group randomised clinical trial. Patients are recruited at respiratory medicine outpatient clinics of participating university and general hospitals in the Netherlands, Poland and Italy. In total 158 adult patients with (suspected) lung cancer are included if they have an indication for mediastinal/hilar lymph node or lung tumour sampling by EBUS-TBNA and/or EUS-B-FNA based on current clinical guidelines. Web-based randomisation between the two needles will be performed. Samples obtained from mediastinal/hilar lymph nodes and/or primary tumour will be processed for cytology smears and cell block analysis and reviewed by blinded reference pathologists. An intention-to-treat analysis will be applied. Patients with missing data will be excluded from analysis for that specific variable but included in the analysis of other variables. This study is financially supported by Boston Scientific. Ethic
Published: 2021

205. To stent or not to stent? Treating angina after ISCHEMIA-Introduction

Author: Gersh, Bj, Boden, We, Bhatt, Dl, Stone, Ph, Crea, F, Luscher, Tf., Crea F (ORCID:0000-0001-9404-8846), Gersh, Bj, Boden, We, Bhatt, Dl, Stone, Ph, Crea, F, Luscher, Tf., and Crea F (ORCID:0000-0001-9404-8846)
Abstract: N/A
Published: 2021

206. Nintedanib in progressive interstitial lung diseases: data from the whole INBUILD trial

Author: Flaherty, Kevin R, Wells, Athol U, Cottin, Vincent, Devaraj, Anand, Inoue, Yoshikazu, Richeldi, Luca, Walsh, Simon L F, Kolb, Martin, Koschel, Dirk, Moua, Teng, Stowasser, Susanne, Goeldner, Rainer-Georg, Schlenker-Herceg, Rozsa, Brown, Kevin K, Richeldi, Luca (ORCID:0000-0001-8594-1448), Flaherty, Kevin R, Wells, Athol U, Cottin, Vincent, Devaraj, Anand, Inoue, Yoshikazu, Richeldi, Luca, Walsh, Simon L F, Kolb, Martin, Koschel, Dirk, Moua, Teng, Stowasser, Susanne, Goeldner, Rainer-Georg, Schlenker-Herceg, Rozsa, Brown, Kevin K, and Richeldi, Luca (ORCID:0000-0001-8594-1448)
Abstract: The primary analysis of the INBUILD trial showed that in subjects with progressive fibrosing interstitial lung diseases (ILDs), nintedanib slowed the decline in forced vital capacity (FVC) over 52 weeks. We report the effects of nintedanib on ILD progression over the whole trial.Subjects with fibrosing ILDs other than idiopathic pulmonary fibrosis, who had ILD progression within the 24 months before screening despite management deemed appropriate in clinical practice, were randomised to receive nintedanib or placebo. Subjects continued on blinded randomised treatment until all subjects had completed the trial. Over the whole trial, mean (sd) exposure to trial medication was 15.6 (7.2) and 16.8 (5.8) months in the nintedanib and placebo groups, respectively.In the nintedanib (n=332) and placebo (n=331) groups, respectively, the proportions of subjects who had ILD progression (absolute decline in FVC ≥10% predicted) or died were 40.4% and 54.7% in the overall population (HR 0.66 [95% CI: 0.53, 0.83]; p=0.0003), and 43.7% and 55.8% among subjects with a usual interstitial pneumonia (UIP)-like fibrotic pattern on high-resolution computed tomography (HRCT) (HR 0.69 [0.53, 0.91]; p=0.009). In the nintedanib and placebo groups, respectively, the proportions who had an acute exacerbation of ILD or died were 13.9% and 19.6% in the overall population (HR 0.67 [95% CI: 0.46, 0.98]; p=0.04), and 15.0% and 22.8% among subjects with a UIP-like fibrotic pattern on HRCT (HR 0.62 [0.39, 0.97]; p=0.03).Based on data from the whole INBUILD trial, nintedanib reduced the risk of events indicating ILD progression.
Published: 2021

207. Respiratory Trajectories in Type 2 and 3 Spinal Muscular Atrophy in the iSMAC Cohort Study

Author: Trucco, F., Ridout, D., Scoto, M., Coratti, Giorgia, Main, M. L., Muni Lofra, R., Mayhew, A. G., Montes, J., Pane, Marika, Sansone, V., Albamonte, E., D'Amico, Adele, Bertini, Enrico Silvio, Messina, S., Bruno, C., Parasuraman, D., Childs, A. -M., Gowda, V., Willis, T., Ong, M., Marini-Bettolo, C., De Vivo, D. C., Darras, B. T., Day, J., Kichula, E. A., Mayer, O. H., Navas Nazario, A. A., Finkel, R. S., Mercuri, Eugenio Maria, Muntoni, F., Coratti G. (ORCID:0000-0001-6666-5628), Pane M. (ORCID:0000-0002-4851-6124), D'Amico A., Bertini E., Mercuri E. (ORCID:0000-0002-9851-5365), Trucco, F., Ridout, D., Scoto, M., Coratti, Giorgia, Main, M. L., Muni Lofra, R., Mayhew, A. G., Montes, J., Pane, Marika, Sansone, V., Albamonte, E., D'Amico, Adele, Bertini, Enrico Silvio, Messina, S., Bruno, C., Parasuraman, D., Childs, A. -M., Gowda, V., Willis, T., Ong, M., Marini-Bettolo, C., De Vivo, D. C., Darras, B. T., Day, J., Kichula, E. A., Mayer, O. H., Navas Nazario, A. A., Finkel, R. S., Mercuri, Eugenio Maria, Muntoni, F., Coratti G. (ORCID:0000-0001-6666-5628), Pane M. (ORCID:0000-0002-4851-6124), D'Amico A., Bertini E., and Mercuri E. (ORCID:0000-0002-9851-5365)
Abstract: OBJECTIVE: To describe the respiratory trajectories and their correlation with motor function in an international pediatric cohort of patients with type 2 and nonambulant type 3 spinal muscular atrophy (SMA). METHODS: This was an 8-year retrospective observational study of patients in the International SMA Consortium (iSMAc) natural history study. We retrieved anthropometrics, forced vital capacity (FVC) absolute, FVC percent predicted (FVC%P), and noninvasive ventilation (NIV) requirement. Hammersmith Functional Motor Scale (HFMS) and revised Performance of Upper Limb (RULM) scores were correlated with respiratory function. We excluded patients in interventional clinical trials and on nusinersen commercial therapy. RESULTS: There were 437 patients with SMA: 348 with type 2 and 89 with nonambulant type 3. Mean age at first visit was 6.9 (±4.4) and 11.1 (±4) years. In SMA type 2, FVC%P declined by 4.2%/y from 5 to 13 years, followed by a slower decline (1.0%/y). In type 3, FVC%P declined by 6.3%/y between 8 and 13 years, followed by a slower decline (0.9%/y). Thirty-nine percent with SMA type 2% and 9% with type 3 required NIV at a median age 5.0 (1.8-16.6) and 15.1 (13.8-16.3) years. Eighty-four percent with SMA type 2% and 80% with type 3 had scoliosis; 54% and 46% required surgery, which did not significantly affect respiratory decline. FVC%P positively correlated with HFMS and RULM scores in both subtypes. CONCLUSIONS: In SMA type 2 and nonambulant type 3, lung function declines differently, with a common leveling after age 13 years. Lung and motor function correlated in both subtypes. Our data further define the milder SMA phenotypes and provide information to benchmark the long-term efficacy of new treatments for SMA.
Published: 2021

208. Asthma in patients admitted to emergency department for COVID-19: prevalence and risk of hospitalization

Author: Gabrielli, Maurizio, Pignataro, Giulia, Candelli, Marcello, Sacco Fernandez, Marta, Bizzarri, Martina, Esperide, Alessandra, Franceschi, Francesco, Abbate, Valeria, Nicola, Acampora, Addolorato, Giovanni, Agostini, Fabiana, Ainora, Maria Elena, Akacha, Karim, Amato, Elena, Andreani, Francesca, Andriollo, Gloria, Annetta, Maria Giuseppina, Annicchiarico, Brigida Eleonora, Mariangela, Antonelli, Antonucci, Gabriele, Marco, Anzellotti Gian, Armuzzi, Alessandro, Baldi, Fabiana, Barattucci, Ilaria, Barillaro, Christian, Fabiana, Barone, Bellantone, Rocco Domenico Alfonso, Andrea, Bellieni, Bello, Giuseppe, Benicchi, Andrea, Benvenuto, Francesca, Berardini, Ludovica, Berloco, Filippo, Bernabei, Roberto, Bianchi, Antonio, Biasucci, Daniele Guerino, Biasucci, Luigi Marzio, Stefano, Bibbò, Bini, Alessandra, Alessandra, Bisanti, Biscetti, Federico, Bocci, Maria Grazia, Nicola, Bonadia, Bongiovanni, Filippo, Borghetti, Alberto, Bosco, Giulia, Bosello, Silvia Laura, Bove, Vincenzo, Bramato, Giulia, Brandi, Vincenzo, Teresa, Bruni, Bruno, Carmine, Bruno, Dario, Bungaro, Maria Chiara, Buonomo, Alessandro, Livia, Burzo, Angelo, Calabrese, Rosaria, Calvello Maria, Andrea, Cambieri, Cambise, Chiara, Camma, Giulia, Gennaro, Canistro, Antonello, Cantanale, Capalbo, Gennaro, Capaldi, Lorenzo, Capone, Emanuele, Capristo, Esmeralda, Carbone, Luigi, Silvia, Cardone, Carelli, Simone, Carfi', Angelo, Annamaria, Carnicelli, Caruso, Cristiano, Antonio, Casciaro Francesco, Catalano, Lucio, Cauda, Roberto, Cecchini, Andrea Leonardo, Cerrito, Lucia, Melania, Cesarano, Chiarito, Annalisa, Cianci, Rossella, Cicetti, Marta, Cicchinelli, Sara, Arturo, Ciccullo, Ciciarello, Francesca, Cingolani, Antonella, Cipriani, Maria Camilla, Consalvo, Ludovica Maria, Coppola, Gaetano, Corbo, Giuseppe Maria, Corsello, Andrea, Costante, Federico, Matteo, Costanzi, Covino, Marcello, Davide, Crupi, Lucio, Cutuli Salvatore, D'Addio, Stefano, D'Alessandro, Alessia, D'Alfonso, Maria Elena, D'Angelo, Emanuela, Francesca, D’Aversa, Damiano, Fernando, De Maria, Berardinis Gian, De Cunzo, Tommaso, De Gaetano Donati, Katleen, De Luca, Giulio, De Matteis, Giuseppe, De Pascale, Gennaro, De Paolo, Santi, De Martina, Siena, De Francesco, Vito, Del Valeria, Gatto, Del Paola, Giacomo, Del Fabio, Zompo, Maria, Dell’Anna Antonio, Della Davide, Polla, Di Luca, Gialleonardo, Di Simona, Giambenedetto, Di Roberta, Luca, Di Luca, Maurizio, Di Mariangela, Muro, Alex, Dusina, Davide, Eleuteri, Alessandra, Esperide, Daniele, Facheci, Domenico, Faliero, Cinzia, Falsiroli, Massimo, Fantoni, Annalaura, Fedele, Daniela, Feliciani, Cristina, Ferrante, Giuliano, Ferrone, Rossano, Festa, Chiara, Fiore Maria, Andrea, Flex, Evelina, Forte, Francesco, Franceschi, Alessandra, Francesconi, Laura, Franza, Barbara, Funaro, Mariella, Fuorlo, Domenico, Fusco, Maurizio, Gabrielli, Eleonora, Gaetani, Claudia, Galletta, Antonella, Gallo, Giovanni, Gambassi, Matteo, Garcovich, Antonio, Gasbarrini, Irene, Gasparrini, Silvia, Gelli, Antonella, Giampietro, Laura, Gigante, Gabriele, Giuliano, Giorgia, Giuliano, Bianca, Giupponi, Elisa, Gremese, Grieco, Domenico Luca, Manuel, Guerrera, Valeria, Guglielmi, Caterina, Guidone, Antonio, Gullì, Amerigo, Iaconelli, Aurora, Iafrati, Ianiro, Gianluca, Angela, Iaquinta, Michele, Impagnatiello, Riccardo, Inchingolo, Enrica, Intini, Raffaele, Iorio, Maria, Izzi Immacolata, Tamara, Jovanovic, Cristina, Kadhim, Rosa, La Macchia, Ignazio, La Milia Daniele, Francesco, Landi, Giovanni, Landi, Rosario, Landi, Raffaele, Landolfi, Massimo, Leo, Maria, Leone Paolo, Laura, Levantesi, Antonio, Liguori, Rosa, Liperoti, Maria, Lizzio Marco, Rita, Lo Monaco Maria, Pietro, Locantore, Francesco, Lombardi, Gianmarco, Lombardi, Loris, Lopetuso, Valentina, Loria, Raffaella, Losito Angela, Patricia, Lucia Mothanje Barbara, Francesco, Macagno, Noemi, Macerola, Giampaolo, Maggi, Giuseppe, Maiuro, Francesco, Mancarella, Francesca, Mangiola, Alberto, Manno, Debora, Marchesini, Marco, Maresca Gian, Giuseppe, Marrone, Ilaria, Marti, Maria, Martone Anna, Marzetti, Emanuele, Chiara, Mattana, Valeria, Matteo Maria, Riccardo, Maviglia, Ada, Mazzarella, Carmen, Memoli, Miele, Luca, Alessio, Migneco, Irene, Mignini, Alessandro, Milani, Domenico, Milardi, Massimo, Montalto, Giuliano, Montemurro, Flavia, Monti, Montini, Luca, Christian, Morena Tony, Vincenzina, Morra, Davide, Moschese, Ambra, Murace Celeste, Martina, Murdolo, Rita, Murri, Marco, Napoli, Elisabetta, Nardella, Gerlando, Natalello, Daniele, Natalini, Maria, Navarra Simone, Antonio, Nesci, Alberto, Nicoletti, Rocco, Nicoletti, Filippo, Nicoletti Tommaso, Rebecca, Nicolò, Nicola, Nicolotti, Celestino, Nista Enrico, Eugenia, Nuzzo, Marco, Oggiano, Veronica, Ojetti, Cosimo, Pagano Francesco, Gianfranco, Paiano, Cristina, Pai, Federico, Paolillo, Federico, Pallavicini, Andrea, Palombo, Alfredo, Papa, Domenico, Papanice, Giovanni, Papparella Luigi, Mattia, Paratore, Giuseppe, Parrinello, Giuliana, Pasciuto, Pierpaolo, Pasculli, Giovanni, Pecorini, Simone, Perniola, Erika, Pero, Luca, Petricca, Martina, Petrucci, Chiara, Picarelli, Andrea, Piccioni, Annalisa, Piccolo, Edoardo, Piervincenzi, Giulia, Pignataro, Raffaele, Pignataro, Gabriele, Pintaudi, Luca, Pisapia, Marco, Pizzoferrato, Fabrizio, Pizzolante, Roberto, Pola, Caterina, Policola, Maurizio, Pompili, Flavia, Pontecorvi, Valerio, Pontecorvi, Francesca, Ponziani, Valentina, Popolla, Enrica, Porceddu, Angelo, Porfidia, Maria, Porro Lucia, Annalisa, Potenza, Francesca, Pozzana, Giuseppe, Privitera, Daniela, Pugliese, Gabriele, Pulcini, Simona, Racco, Francesca, Raffaelli, Vittoria, Ramunno, Ludovico, Rapaccini Gian, Richeldi, Luca, Rinninella, Emanuele, Sara, Rocchi, Bruno, Romanò, Stefano, Romano, Federico, Rosa, Laura, Rossi, Raimondo, Rossi, Enrica, Rossini, Elisabetta, Rota, Fabiana, Rovedi, Carlotta, Rubino, Gabriele, Rumi, Andrea, Russo, Luca, Sabia, Andrea, Salerno, Sara, Salini, Lucia, Salvatore, Dehara, Samori, Sandroni, Claudio, Maurizio, Sanguinetti, Luca, Santarelli, Paolo, Santini, Danilo, Santolamazza, Angelo, Santoliquido, Francesco, Santopaolo, Cosimo, Santoro Michele, Francesco, Sardeo, Caterina, Sarnari, Angela, Saviano, Luisa, Saviano, Scaldaferri, Franco, Roberta, Scarascia, Tommaso, Schepi, Francesca, Schiavello, Giancarlo, Scoppettuolo, Davide, Sedda, Flaminio, Sessa, Luisa, Sestito, Carlo, Settanni, Matteo, Siciliano, Valentina, Siciliano, Rossella, Sicuranza, Benedetta, Simeoni, Jacopo, Simonetti, Andrea, Smargiassi, Maurizio, Soave Paolo, Chiara, Sonnino, Domenico, Staiti, Claudia, Stella, Leonardo, Stella, Eleonora, Stival, Eleonora, Taddei, Rossella, Talerico, Elio, Tamburello, Enrica, Tamburrini, Sofia, Tanzarella Eloisa, Elena, Tarascio, Claudia, Tarli, Alessandra, Tersali, Pietro, Tilli, Jacopo, Timpano, Enrico, Torelli, Flavia, Torrini, Matteo, Tosato, Alberto, Tosoni, Luca, Tricoli, Marcello, Tritto, Mario, Tumbarello, Maria, Tummolo Anita, Sole, Vallecoccia Maria, Federico, Valletta, Francesco, Varone, Francesco, Vassalli, Giulio, Ventura, Lucrezia, Verardi, Lorenzo, Vetrone, Giuseppe, Vetrugno, Elena, Visconti, Felicia, Visconti, Andrea, Viviani, Raffaella, Zaccaria, Carmelina, Zaccone, Lorenzo, Zelano, Lorenzo, Zileri Dal Verme, Giuseppe, Zuccalà, Candelli, Marcello (ORCID:0000-0001-8443-7880), Franceschi, Francesco (ORCID:0000-0001-6266-445X), Valeria, Abbate, Giovanni, Addolorato (ORCID:0000-0002-1522-9946), Fabiana, Agostini, Elena, Ainora Maria, Karim, Akacha, Elena, Amato, Francesca, Andreani, Gloria, Andriollo, Giuseppina, Annetta Maria (ORCID:0000-0001-7574-1311), Eleonora, Annicchiarico Brigida, Gabriele, Antonucci, Alessandro, Armuzzi (ORCID:0000-0003-1572-0118), Fabiana, Baldi, Ilaria, Barattucci, Christian, Barillaro, Alfonso, Bellantone Rocco Domenico (ORCID:0000-0002-0844-3469), Giuseppe, Bello (ORCID:0000-0003-2648-7235), Andrea, Benicchi, Francesca, Benvenuto, Ludovica, Berardini, Filippo, Berloco, Roberto, Bernabei (ORCID:0000-0002-9197-004X), Antonio, Bianchi, Guerino, Biasucci Daniele, Marzio, Biasucci Luigi (ORCID:0000-0002-6921-6497), Alessandra, Bini, Federico, Biscetti (ORCID:0000-0001-7449-657X), Grazia, Bocci Maria, Filippo, Bongiovanni, Alberto, Borghetti, Giulia, Bosco, Silvia, Bosello (ORCID:0000-0002-4837-447X), Vincenzo, Bove, Giulia, Bramato, Vincenzo, Brandi, Carmine, Bruno, Dario, Bruno, Chiara, Bungaro Maria, Alessandro, Buonomo, Chiara, Cambise, Giulia, Cammà, Marcello, Candelli (ORCID:0000-0001-8443-7880), Gennaro, Capalbo, Lorenzo, Capaldi, Emanuele, Capone, Esmeralda, Capristo (ORCID:0000-0002-5753-3495), Luigi, Carbone, Simone, Carelli, Angelo, Carfì, Cristiano, Caruso, Lucio, Catalano, Roberto, Cauda (ORCID:0000-0002-1498-4229), Leonardo, Cecchini Andrea, Lucia, Cerrito, Annalisa, Chiarito, Rossella, Cianci (ORCID:0000-0001-5378-8442), Marta, Cicetti, Sara, Cicchinelli, Francesca, Ciciarello, Antonella, Cingolani (ORCID:0000-0002-3793-2755), Camilla, Cipriani Maria, Ludovica, Consalvo Maria, Gaetano, Coppola, Maria, Corbo Giuseppe (ORCID:0000-0002-8104-4659), Andrea, Corsello, Federico, Costante, Marcello, Covino (ORCID:0000-0002-6709-2531), Stefano, D’Addio, Alessia, D’Alessandro, Elena, D’alfonso Maria, Emanuela, D’Angelo, Fernando, Damiano (ORCID:0000-0003-0960-0232), De Tommaso, Cunzo, de Katleen, Gaetano Donati, De Giulio, Luca, De Giuseppe, Matteis, De Gennaro, Pascale (ORCID:0000-0002-8255-0676), Luca, Grieco Domenico (ORCID:0000-0002-4557-6308), Gianluca, Ianiro (ORCID:0000-0002-8318-0515), Emanuele, Marzetti (ORCID:0000-0001-9567-6983), Luca, Miele (ORCID:0000-0003-3464-0068), Luca, Montini (ORCID:0000-0003-4602-5134), Luca, Richeldi (ORCID:0000-0001-8594-1448), Emanuele, Rinninella (ORCID:0000-0002-9165-2367), Claudio, Sandroni (ORCID:0000-0002-8878-2611), Franco, Scaldaferri (ORCID:0000-0001-8334-7541), Gabrielli, Maurizio, Pignataro, Giulia, Candelli, Marcello, Sacco Fernandez, Marta, Bizzarri, Martina, Esperide, Alessandra, Franceschi, Francesco, Abbate, Valeria, Nicola, Acampora, Addolorato, Giovanni, Agostini, Fabiana, Ainora, Maria Elena, Akacha, Karim, Amato, Elena, Andreani, Francesca, Andriollo, Gloria, Annetta, Maria Giuseppina, Annicchiarico, Brigida Eleonora, Mariangela, Antonelli, Antonucci, Gabriele, Marco, Anzellotti Gian, Armuzzi, Alessandro, Baldi, Fabiana, Barattucci, Ilaria, Barillaro, Christian, Fabiana, Barone, Bellantone, Rocco Domenico Alfonso, Andrea, Bellieni, Bello, Giuseppe, Benicchi, Andrea, Benvenuto, Francesca, Berardini, Ludovica, Berloco, Filippo, Bernabei, Roberto, Bianchi, Antonio, Biasucci, Daniele Guerino, Biasucci, Luigi Marzio, Stefano, Bibbò, Bini, Alessandra, Alessandra, Bisanti, Biscetti, Federico, Bocci, Maria Grazia, Nicola, Bonadia, Bongiovanni, Filippo, Borghetti, Alberto, Bosco, Giulia, Bosello, Silvia Laura, Bove, Vincenzo, Bramato, Giulia, Brandi, Vincenzo, Teresa, Bruni, Bruno, Carmine, Bruno, Dario, Bungaro, Maria Chiara, Buonomo, Alessandro, Livia, Burzo, Angelo, Calabrese, Rosaria, Calvello Maria, Andrea, Cambieri, Cambise, Chiara, Camma, Giulia, Gennaro, Canistro, Antonello, Cantanale, Capalbo, Gennaro, Capaldi, Lorenzo, Capone, Emanuele, Capristo, Esmeralda, Carbone, Luigi, Silvia, Cardone, Carelli, Simone, Carfi', Angelo, Annamaria, Carnicelli, Caruso, Cristiano, Antonio, Casciaro Francesco, Catalano, Lucio, Cauda, Roberto, Cecchini, Andrea Leonardo, Cerrito, Lucia, Melania, Cesarano, Chiarito, Annalisa, Cianci, Rossella, Cicetti, Marta, Cicchinelli, Sara, Arturo, Ciccullo, Ciciarello, Francesca, Cingolani, Antonella, Cipriani, Maria Camilla, Consalvo, Ludovica Maria, Coppola, Gaetano, Corbo, Giuseppe Maria, Corsello, Andrea, Costante, Federico, Matteo, Costanzi, Covino, Marcello, Davide, Crupi, Lucio, Cutuli Salvatore, D'Addio, Stefano, D'Alessandro, Alessia, D'Alfonso, Maria Elena, D'Angelo, Emanuela, Francesca, D’Aversa, Damiano, Fernando, De Maria, Berardinis Gian, De Cunzo, Tommaso, De Gaetano Donati, Katleen, De Luca, Giulio, De Matteis, Giuseppe, De Pascale, Gennaro, De Paolo, Santi, De Martina, Siena, De Francesco, Vito, Del Valeria, Gatto, Del Paola, Giacomo, Del Fabio, Zompo, Maria, Dell’Anna Antonio, Della Davide, Polla, Di Luca, Gialleonardo, Di Simona, Giambenedetto, Di Roberta, Luca, Di Luca, Maurizio, Di Mariangela, Muro, Alex, Dusina, Davide, Eleuteri, Alessandra, Esperide, Daniele, Facheci, Domenico, Faliero, Cinzia, Falsiroli, Massimo, Fantoni, Annalaura, Fedele, Daniela, Feliciani, Cristina, Ferrante, Giuliano, Ferrone, Rossano, Festa, Chiara, Fiore Maria, Andrea, Flex, Evelina, Forte, Francesco, Franceschi, Alessandra, Francesconi, Laura, Franza, Barbara, Funaro, Mariella, Fuorlo, Domenico, Fusco, Maurizio, Gabrielli, Eleonora, Gaetani, Claudia, Galletta, Antonella, Gallo, Giovanni, Gambassi, Matteo, Garcovich, Antonio, Gasbarrini, Irene, Gasparrini, Silvia, Gelli, Antonella, Giampietro, Laura, Gigante, Gabriele, Giuliano, Giorgia, Giuliano, Bianca, Giupponi, Elisa, Gremese, Grieco, Domenico Luca, Manuel, Guerrera, Valeria, Guglielmi, Caterina, Guidone, Antonio, Gullì, Amerigo, Iaconelli, Aurora, Iafrati, Ianiro, Gianluca, Angela, Iaquinta, Michele, Impagnatiello, Riccardo, Inchingolo, Enrica, Intini, Raffaele, Iorio, Maria, Izzi Immacolata, Tamara, Jovanovic, Cristina, Kadhim, Rosa, La Macchia, Ignazio, La Milia Daniele, Francesco, Landi, Giovanni, Landi, Rosario, Landi, Raffaele, Landolfi, Massimo, Leo, Maria, Leone Paolo, Laura, Levantesi, Antonio, Liguori, Rosa, Liperoti, Maria, Lizzio Marco, Rita, Lo Monaco Maria, Pietro, Locantore, Francesco, Lombardi, Gianmarco, Lombardi, Loris, Lopetuso, Valentina, Loria, Raffaella, Losito Angela, Patricia, Lucia Mothanje Barbara, Francesco, Macagno, Noemi, Macerola, Giampaolo, Maggi, Giuseppe, Maiuro, Francesco, Mancarella, Francesca, Mangiola, Alberto, Manno, Debora, Marchesini, Marco, Maresca Gian, Giuseppe, Marrone, Ilaria, Marti, Maria, Martone Anna, Marzetti, Emanuele, Chiara, Mattana, Valeria, Matteo Maria, Riccardo, Maviglia, Ada, Mazzarella, Carmen, Memoli, Miele, Luca, Alessio, Migneco, Irene, Mignini, Alessandro, Milani, Domenico, Milardi, Massimo, Montalto, Giuliano, Montemurro, Flavia, Monti, Montini, Luca, Christian, Morena Tony, Vincenzina, Morra, Davide, Moschese, Ambra, Murace Celeste, Martina, Murdolo, Rita, Murri, Marco, Napoli, Elisabetta, Nardella, Gerlando, Natalello, Daniele, Natalini, Maria, Navarra Simone, Antonio, Nesci, Alberto, Nicoletti, Rocco, Nicoletti, Filippo, Nicoletti Tommaso, Rebecca, Nicolò, Nicola, Nicolotti, Celestino, Nista Enrico, Eugenia, Nuzzo, Marco, Oggiano, Veronica, Ojetti, Cosimo, Pagano Francesco, Gianfranco, Paiano, Cristina, Pai, Federico, Paolillo, Federico, Pallavicini, Andrea, Palombo, Alfredo, Papa, Domenico, Papanice, Giovanni, Papparella Luigi, Mattia, Paratore, Giuseppe, Parrinello, Giuliana, Pasciuto, Pierpaolo, Pasculli, Giovanni, Pecorini, Simone, Perniola, Erika, Pero, Luca, Petricca, Martina, Petrucci, Chiara, Picarelli, Andrea, Piccioni, Annalisa, Piccolo, Edoardo, Piervincenzi, Giulia, Pignataro, Raffaele, Pignataro, Gabriele, Pintaudi, Luca, Pisapia, Marco, Pizzoferrato, Fabrizio, Pizzolante, Roberto, Pola, Caterina, Policola, Maurizio, Pompili, Flavia, Pontecorvi, Valerio, Pontecorvi, Francesca, Ponziani, Valentina, Popolla, Enrica, Porceddu, Angelo, Porfidia, Maria, Porro Lucia, Annalisa, Potenza, Francesca, Pozzana, Giuseppe, Privitera, Daniela, Pugliese, Gabriele, Pulcini, Simona, Racco, Francesca, Raffaelli, Vittoria, Ramunno, Ludovico, Rapaccini Gian, Richeldi, Luca, Rinninella, Emanuele, Sara, Rocchi, Bruno, Romanò, Stefano, Romano, Federico, Rosa, Laura, Rossi, Raimondo, Rossi, Enrica, Rossini, Elisabetta, Rota, Fabiana, Rovedi, Carlotta, Rubino, Gabriele, Rumi, Andrea, Russo, Luca, Sabia, Andrea, Salerno, Sara, Salini, Lucia, Salvatore, Dehara, Samori, Sandroni, Claudio, Maurizio, Sanguinetti, Luca, Santarelli, Paolo, Santini, Danilo, Santolamazza, Angelo, Santoliquido, Francesco, Santopaolo, Cosimo, Santoro Michele, Francesco, Sardeo, Caterina, Sarnari, Angela, Saviano, Luisa, Saviano, Scaldaferri, Franco, Roberta, Scarascia, Tommaso, Schepi, Francesca, Schiavello, Giancarlo, Scoppettuolo, Davide, Sedda, Flaminio, Sessa, Luisa, Sestito, Carlo, Settanni, Matteo, Siciliano, Valentina, Siciliano, Rossella, Sicuranza, Benedetta, Simeoni, Jacopo, Simonetti, Andrea, Smargiassi, Maurizio, Soave Paolo, Chiara, Sonnino, Domenico, Staiti, Claudia, Stella, Leonardo, Stella, Eleonora, Stival, Eleonora, Taddei, Rossella, Talerico, Elio, Tamburello, Enrica, Tamburrini, Sofia, Tanzarella Eloisa, Elena, Tarascio, Claudia, Tarli, Alessandra, Tersali, Pietro, Tilli, Jacopo, Timpano, Enrico, Torelli, Flavia, Torrini, Matteo, Tosato, Alberto, Tosoni, Luca, Tricoli, Marcello, Tritto, Mario, Tumbarello, Maria, Tummolo Anita, Sole, Vallecoccia Maria, Federico, Valletta, Francesco, Varone, Francesco, Vassalli, Giulio, Ventura, Lucrezia, Verardi, Lorenzo, Vetrone, Giuseppe, Vetrugno, Elena, Visconti, Felicia, Visconti, Andrea, Viviani, Raffaella, Zaccaria, Carmelina, Zaccone, Lorenzo, Zelano, Lorenzo, Zileri Dal Verme, Giuseppe, Zuccalà, Candelli, Marcello (ORCID:0000-0001-8443-7880), Franceschi, Francesco (ORCID:0000-0001-6266-445X), Valeria, Abbate, Giovanni, Addolorato (ORCID:0000-0002-1522-9946), Fabiana, Agostini, Elena, Ainora Maria, Karim, Akacha, Elena, Amato, Francesca, Andreani, Gloria, Andriollo, Giuseppina, Annetta Maria (ORCID:0000-0001-7574-1311), Eleonora, Annicchiarico Brigida, Gabriele, Antonucci, Alessandro, Armuzzi (ORCID:0000-0003-1572-0118), Fabiana, Baldi, Ilaria, Barattucci, Christian, Barillaro, Alfonso, Bellantone Rocco Domenico (ORCID:0000-0002-0844-3469), Giuseppe, Bello (ORCID:0000-0003-2648-7235), Andrea, Benicchi, Francesca, Benvenuto, Ludovica, Berardini, Filippo, Berloco, Roberto, Bernabei (ORCID:0000-0002-9197-004X), Antonio, Bianchi, Guerino, Biasucci Daniele, Marzio, Biasucci Luigi (ORCID:0000-0002-6921-6497), Alessandra, Bini, Federico, Biscetti (ORCID:0000-0001-7449-657X), Grazia, Bocci Maria, Filippo, Bongiovanni, Alberto, Borghetti, Giulia, Bosco, Silvia, Bosello (ORCID:0000-0002-4837-447X), Vincenzo, Bove, Giulia, Bramato, Vincenzo, Brandi, Carmine, Bruno, Dario, Bruno, Chiara, Bungaro Maria, Alessandro, Buonomo, Chiara, Cambise, Giulia, Cammà, Marcello, Candelli (ORCID:0000-0001-8443-7880), Gennaro, Capalbo, Lorenzo, Capaldi, Emanuele, Capone, Esmeralda, Capristo (ORCID:0000-0002-5753-3495), Luigi, Carbone, Simone, Carelli, Angelo, Carfì, Cristiano, Caruso, Lucio, Catalano, Roberto, Cauda (ORCID:0000-0002-1498-4229), Leonardo, Cecchini Andrea, Lucia, Cerrito, Annalisa, Chiarito, Rossella, Cianci (ORCID:0000-0001-5378-8442), Marta, Cicetti, Sara, Cicchinelli, Francesca, Ciciarello, Antonella, Cingolani (ORCID:0000-0002-3793-2755), Camilla, Cipriani Maria, Ludovica, Consalvo Maria, Gaetano, Coppola, Maria, Corbo Giuseppe (ORCID:0000-0002-8104-4659), Andrea, Corsello, Federico, Costante, Marcello, Covino (ORCID:0000-0002-6709-2531), Stefano, D’Addio, Alessia, D’Alessandro, Elena, D’alfonso Maria, Emanuela, D’Angelo, Fernando, Damiano (ORCID:0000-0003-0960-0232), De Tommaso, Cunzo, de Katleen, Gaetano Donati, De Giulio, Luca, De Giuseppe, Matteis, De Gennaro, Pascale (ORCID:0000-0002-8255-0676), Luca, Grieco Domenico (ORCID:0000-0002-4557-6308), Gianluca, Ianiro (ORCID:0000-0002-8318-0515), Emanuele, Marzetti (ORCID:0000-0001-9567-6983), Luca, Miele (ORCID:0000-0003-3464-0068), Luca, Montini (ORCID:0000-0003-4602-5134), Luca, Richeldi (ORCID:0000-0001-8594-1448), Emanuele, Rinninella (ORCID:0000-0002-9165-2367), Claudio, Sandroni (ORCID:0000-0002-8878-2611), and Franco, Scaldaferri (ORCID:0000-0001-8334-7541)
Published: 2021

209. Telemedicine-enabled, Hotel-based Management of Patients with COVID-19: A Single-Center Feasibility Study

Author: Sgalla, Giacomo, Iovene, Bruno, Bruni, Teresa, Flore, Maria Chiara, Porro, Lucia Maria, Lalvani, Ajit, Richeldi, Luca, Sgalla, Giacomo (ORCID:0000-0003-3130-9388), Richeldi, Luca (ORCID:0000-0001-8594-1448), Sgalla, Giacomo, Iovene, Bruno, Bruni, Teresa, Flore, Maria Chiara, Porro, Lucia Maria, Lalvani, Ajit, Richeldi, Luca, Sgalla, Giacomo (ORCID:0000-0003-3130-9388), and Richeldi, Luca (ORCID:0000-0001-8594-1448)
Published: 2021

210. Manifesto on the overuse of SABA in the management of asthma: new approaches and new strategies

Author: Canonica, Giorgio Walter, Paggiaro, Pierluigi, Blasi, Francesco, Musarra, Antonino, Richeldi, Luca, Rossi, Andrea, Papi, Alberto, Richeldi, Luca (ORCID:0000-0001-8594-1448), Canonica, Giorgio Walter, Paggiaro, Pierluigi, Blasi, Francesco, Musarra, Antonino, Richeldi, Luca, Rossi, Andrea, Papi, Alberto, and Richeldi, Luca (ORCID:0000-0001-8594-1448)
Abstract: The risks of overusing short-acting beta(2)-agonists (SABA), including an increase in asthma-related deaths, are many and well known. The Global Initiative on Asthma (GINA) 2019 and 2020 updates recommend as-needed inhaled corticosteroid (ICS)/formoterol as the preferred rescue medication in mild asthma as monotherapy and also in moderate to severe asthma when the maintenance and reliever therapy (MART) strategy is used. Using SABA for symptom relief, however, was the standard of treatment for many years, and consequently this practice persists, particularly in patients not taking ICS regularly. Here, we examine the rationale for this shift from a long-standing recommendation for as-needed SABA treatment to the use of as-needed ICS/formoterol and consider clinical evidence on strategies for asthma treatment and patient management.
Published: 2021

211. Emerging drugs for the treatment of idiopathic pulmonary fibrosis: 2020 phase II clinical trials

Author: Sgalla, Giacomo, Lerede, Marialessia, Richeldi, Luca, Sgalla, Giacomo (ORCID:0000-0003-3130-9388), Richeldi, Luca (ORCID:0000-0001-8594-1448), Sgalla, Giacomo, Lerede, Marialessia, Richeldi, Luca, Sgalla, Giacomo (ORCID:0000-0003-3130-9388), and Richeldi, Luca (ORCID:0000-0001-8594-1448)
Abstract: Introduction The enthusiasm generated by the approval of pirfenidone and nintedanib as the first effective therapies for IPF led the IPF scientific community to investigate an increasing number of novel agents in well-designed randomized controlled trials, in the hope to find a cure for these patients. Areas covered This reviews the evidence from IPF phase II trials that were completed or started in 2020. Literature search was performed using Medline and Clinicaltrials.org databases. Expert opinion Randomized clinical trials revolutionized the management of IPF, leading to the discovery of the first therapies capable of slowing down functional deterioration in these patients. The recently published findings of the first successful phase II trials since pirfenidone and nintedanib will hopefully inaugurate a new era in the therapeutic scenario of IPF, where consolidated treatments of proven efficacy and novel targeted agents contribute together to reach the final goal of halting the fibrotic process of this dreadful disease.
Published: 2021

212. Post-COVID lung fibrosis: The tsunami that will follow the earthquake

Author: Udwadia, Zarir F, Koul, Parvaiz A, Richeldi, Luca, Richeldi, Luca (ORCID:0000-0001-8594-1448), Udwadia, Zarir F, Koul, Parvaiz A, Richeldi, Luca, and Richeldi, Luca (ORCID:0000-0001-8594-1448)
Abstract: The SARS-CoV-2 pandemic has already infected in excess of 50 million people worldwide and resulted in 1.2 million deaths. While the majority of those infected will not have long-term pulmonary sequelae, 5%-10% will develop severe COVID-19 pneumonia and acute respiratory distress syndrome (ARDS). The natural history of these severely affected patients is unclear at present, but using our knowledge of closely related coronavirus outbreaks like severe acute respiratory distress syndrome (SARS) and middle east respiratory syndrome (MERS), we would hypothesize that the majority will stabilize or improve over time although some patients will progress to advanced lung fibrosis or post-COVID interstitial lung disease (PC-ILD). Unlike the SARS and MERS outbreaks which affected only a few thousands, the sheer scale of the present pandemic suggests that physicians are likely to encounter large numbers of patients (potentially hundreds of thousands) with PC-ILD. In this review, we discuss the pathogenesis, natural history, and radiology of such patients and touch on clinical, laboratory, and radiographic clues at presentation which might help predict the future development of lung fibrosis. Finally, we discuss the responsible use of antifibrotic drugs such as pirfenidone, nintedanib, and some newer antifibrotics, still in the pipeline. The biological rationale of these drugs and the patient groups where they may have a plausible role will be discussed. We conclude by stressing the importance of careful longitudinal follow-up of multiple cohorts of post-COVID survivors with serial lung function and imaging. This will eventually help to determine the natural history, course, and response to therapy of these patients.
Published: 2021

213. The impact of fixed triple therapy with beclometasone/formoterol/glycopyrronium on health status and adherence in chronic obstructive pulmonary disease (COPD) in an italian context of real life: The TRITRIAL study protocol

Author: Richeldi, L., Piraino, A., Macagno, F., Micarelli, G., Ingrassia, E., Richeldi L. (ORCID:0000-0001-8594-1448), Macagno F., Richeldi, L., Piraino, A., Macagno, F., Micarelli, G., Ingrassia, E., Richeldi L. (ORCID:0000-0001-8594-1448), and Macagno F.
Abstract: Background: The fixed triple combination Beclometasone dipropionate/Formoterol fuma- rate/Glycopyrronium (BDP/FF/G, Trimbow®), an extrafine formulation in a unique pressur- ized metered dose inhaler, is indicated for the maintenance treatment in adult patients with moderate to severe COPD, not adequately treated by ICS/LABA or LABA/LAMA. Besides the evidence from three randomized controlled trials, the impact of fixed triple therapy has not been extensively evaluated in a real-world population of COPD patients. TRITRIAL (TRIple Therapy in Real life: Impact on Adherence and HeaLth status) is a non- interventional study to assess the effect of BDP/FF/G in a real world setting in Italy. Design: TRITRIAL is a 12-month, multicenter, cohort, prospective, longitudinal observational study. Two follow-up visits will be performed at 6 and 12 months, respectively. The study includes the collection of anamnestic clinical and functional data before the start of BDP/FF/G. The study is built for digital conduction, from signature of the informed consent on a dedicated web platform, to the collection of questionnaires and clinical data on the eCRF. Population: A total of 800 patients with COPD ranging from Global Initiative for Obstructive Lung Disease (GOLD) stages 2 to 4, receiving therapy with BDP/FF/G accord- ing to the Summary of Product Characteristics and local clinical practice, will be recruited. All concomitant therapies will be permitted for the duration of the study. Evaluations: The primary endpoint is the change of CAT score at 12 months versus baseline. Secondary endpoints are adherence, health-related quality of life, sleep quality, disease-related outcomes (lung function and COPD exacerbations), device usability, eco- nomic resources consumption, and safety. Conclusion: TRITRIAL study is expected to give relevant information about effectiveness of BDP/FF/G fixed triple therapy in a real-life setting of patients with COPD, where adherence, usability of inhalers and
Published: 2021

214. Phase three clinical trials in idiopathic pulmonary fibrosis

Author: Sgalla, Giacomo, Lerede, Marialessia, Richeldi, Luca, Sgalla G. (ORCID:0000-0003-3130-9388), Lerede M., Richeldi L. (ORCID:0000-0001-8594-1448), Sgalla, Giacomo, Lerede, Marialessia, Richeldi, Luca, Sgalla G. (ORCID:0000-0003-3130-9388), Lerede M., and Richeldi L. (ORCID:0000-0001-8594-1448)
Abstract: Introduction: The last two decades witnessed an increasing number of well-designed late phase trials in patients with Idiopathic Pulmonary Fibrosis (IPF), leading to the approval of the first effective therapies for these patients, pirfenidone and nintedanib. Currently, novel putative agents for the treatment of IPF are being tested in phase III trials, possibly marking a new breakthrough in IPF management. Areas covered: In this review, the available evidence on completed phase III trials in IPF is summarized, from the past failures of immunosuppressive and anti-inflammatory agents, anticoagulants and endothelin-receptor antagonists to the positive results of the antifibrotic treatments that revolutionized IPF therapeutic landscape. Literature search was performed using Medline and Clinicaltrials.org databases (1999–2020). Expert opinion: In the relatively young history of pharmaceutical research in IPF, most phase III trials provided disappointing results, however the lessons learned helped paving the way to the success of the first therapies capable of modifying the natural history of this deadly disease. To date, the conduction of robustly designed phase III trials on novel drugs remains crucial to pursue the goal of halting disease progression in these patients, using a therapeutic approach that should become more and more tailored to the individual.
Published: 2021

215. Economic impact of mepolizumab in uncontrolled severe eosinophilic asthma, in real life

Author: Bagnasco, D., Povero, M., Pradelli, L., Brussino, L., Rolla, G., Caminati, M., Menzella, F., Heffler, E., Canonica, G. W., Paggiaro, P., Senna, G., Milanese, M., Lombardi, C., Bucca, C., Manfredi, A., Canevari, R. F., Passalacqua, G., Guarnieri, G., Patella, V., Maria Pia, F. B., Carpagnano, E., Colle, A. D., Scioscia, G., Gerolamo, P., Latorre, M., Puggioni, F., Racca, F., Favero, E., Iannacone, S., Savi, E., Montagni, M., Camiciottoli, G., Allegrini, C., Spadaro, G., Detoraki, C., Galeone, C., Ruggiero, P., Yacoub, M. R., Berti, Andrea, Colombo, G., Scichilone, N., Durante, C., Costantino, M. T., Roncallo, C., Braschi, M., Blasi, F., D'Adda, A., Ridolo, E., Triggiani, M., Parente, R., Maria, D. A., Verrillo, M. V., Cristina, Z. M., Lilli, M., Crimi, N., Bonavia, M., Corsico, A. G., Grosso, A., Del Giacco, S., Deidda, M., Ricciardi, L., Isola, S., Cicero, F., Amato, G., Vita, F., Spanevello, A., Pignatti, P., Cherubino, F., Visca, D., Aletti, E., Massimo Ricciardolo, F. L., Anna Carriero, V. M., Bertolini, Francesca, Santus, P., Barlassina, R., Airoldi, A., Guida, Maria Grazia, Nucera, Eleonora, Aruanno, A., Rizzi, Angela, Caruso, C., Colantuono, S., Arcolaci, A., Vianello, A., Bianchi, F. C., Marchi, M. R., Centanni, S., Luraschi, S., Ruggeri, S., Rinaldo, R., Parazzini, E., Calabrese, Anna Chiara, Flora, M., Cosmi, L., Di Pietro, L., Maggi, E., Pini, L., Macchia, L., Di Bona, D., Richeldi, Luca, Condoluci, Carola, Fuso, Leonello, Bonini, Matteo, Farsi, A., Carli, G., Montuschi, Paolo, Santini, G., Conte, M. E., Turchet, E., Barbetta, C., Mazza, F., D'Alo, S., Pucci, S., Caiaffa, M. F., Minenna, E., D'Elia, L., Pasculli, C., Viviano, V., Tarsia, P., Rolo, J., Di Proietto, M., Lo Cicero, Stefano, Berti A., Bertolini F., Guida G., Eleonora N. (ORCID:0000-0002-0565-7680), Rizzi A. (ORCID:0000-0002-6795-746X), Calabrese C., Richeldi L. (ORCID:0000-0001-8594-1448), Condoluci C., Fuso L. (ORCID:0000-0002-1198-6712), Bonini M. (ORCID:0000-0002-3042-0765), Montuschi P. (ORCID:0000-0001-5589-1750), Lo Cicero S., Bagnasco, D., Povero, M., Pradelli, L., Brussino, L., Rolla, G., Caminati, M., Menzella, F., Heffler, E., Canonica, G. W., Paggiaro, P., Senna, G., Milanese, M., Lombardi, C., Bucca, C., Manfredi, A., Canevari, R. F., Passalacqua, G., Guarnieri, G., Patella, V., Maria Pia, F. B., Carpagnano, E., Colle, A. D., Scioscia, G., Gerolamo, P., Latorre, M., Puggioni, F., Racca, F., Favero, E., Iannacone, S., Savi, E., Montagni, M., Camiciottoli, G., Allegrini, C., Spadaro, G., Detoraki, C., Galeone, C., Ruggiero, P., Yacoub, M. R., Berti, Andrea, Colombo, G., Scichilone, N., Durante, C., Costantino, M. T., Roncallo, C., Braschi, M., Blasi, F., D'Adda, A., Ridolo, E., Triggiani, M., Parente, R., Maria, D. A., Verrillo, M. V., Cristina, Z. M., Lilli, M., Crimi, N., Bonavia, M., Corsico, A. G., Grosso, A., Del Giacco, S., Deidda, M., Ricciardi, L., Isola, S., Cicero, F., Amato, G., Vita, F., Spanevello, A., Pignatti, P., Cherubino, F., Visca, D., Aletti, E., Massimo Ricciardolo, F. L., Anna Carriero, V. M., Bertolini, Francesca, Santus, P., Barlassina, R., Airoldi, A., Guida, Maria Grazia, Nucera, Eleonora, Aruanno, A., Rizzi, Angela, Caruso, C., Colantuono, S., Arcolaci, A., Vianello, A., Bianchi, F. C., Marchi, M. R., Centanni, S., Luraschi, S., Ruggeri, S., Rinaldo, R., Parazzini, E., Calabrese, Anna Chiara, Flora, M., Cosmi, L., Di Pietro, L., Maggi, E., Pini, L., Macchia, L., Di Bona, D., Richeldi, Luca, Condoluci, Carola, Fuso, Leonello, Bonini, Matteo, Farsi, A., Carli, G., Montuschi, Paolo, Santini, G., Conte, M. E., Turchet, E., Barbetta, C., Mazza, F., D'Alo, S., Pucci, S., Caiaffa, M. F., Minenna, E., D'Elia, L., Pasculli, C., Viviano, V., Tarsia, P., Rolo, J., Di Proietto, M., Lo Cicero, Stefano, Berti A., Bertolini F., Guida G., Eleonora N. (ORCID:0000-0002-0565-7680), Rizzi A. (ORCID:0000-0002-6795-746X), Calabrese C., Richeldi L. (ORCID:0000-0001-8594-1448), Condoluci C., Fuso L. (ORCID:0000-0002-1198-6712), Bonini M. (ORCID:0000-0002-3042-0765), Montuschi P. (ORCID:0000-0001-5589-1750), and Lo Cicero S.
Abstract: Background and aims: Severe asthma is burdened by frequent exacerbations and use of oral corticosteroids (OCS) which worsen patients’ health and increase healthcare spending. Aim of this study was to assess the clinical and economic effect of adding mepolizumab (MEP) for the treatment of these patients. Methods: Patients >18 years old, referred to 8 asthma clinics, starting MEP between May 2017 and December 2018, were enrolled and followed-up for 12 months. Information in the 12 months before mepolizumab were collected retrospectively. The evaluation parameters included: OCS use, number of exacerbations/hospitalizations, concomitant therapies, comorbidity, and annual number of working days lost due to the disease. The primary objective was to compare the annual total cost per patient pre- and post-MEP. Secondary outcomes included rates of exacerbations and number of OCS-dependent patients. Results: 106 patients were enrolled in the study: 46 male, median age 58 years. Mean annual cost pre- and post-MEP (cost of biologic excluded) was €3996 and €1,527, respectively. Total savings due to MEP resulted in €2469 (95%CI 1945–2993), 62% due to exacerbations reduction and 33% due to productivity increase. Such savings could fund about 22% of the total cost of MEP for one year. The introduction of MEP induced a clinical benefit by reducing both OCS-dependent patients (OR = 0.12, 95%CI 0.06–0.23) and exacerbation rate (RR = 0.19, 95%CI 0.15–0.24). Conclusions: Patients with severe eosinophilic asthma experienced a clinical benefit in asthma control adding MEP to standard therapy. Biologic therapy can be, partially, funded by the savings produced by patients’ improvement.
Published: 2021

216. Utility of a Molecular Classifier as a Complement to High-Resolution Computed Tomography to Identify Usual Interstitial Pneumonia

Author: Richeldi, Luca, Scholand, Mary Beth, Lynch, David A, Colby, Thomas V, Myers, Jeffrey L, Groshong, Steve D, Chung, Jonathan H, Benzaquen, Sadia, Nathan, Steven D, Davis, J Russell, Schmidt, Shelley L, Hagmeyer, Lar, Sonetti, David, Hetzel, Jurgen, Criner, Gerard J, Case, Amy H, Ramaswamy, Murali, Calero, Karel, Gauhar, Umair A, Patel, Nina M, Lancaster, Lisa, Choi, Yoonha, Pankratz, Daniel G, Walsh, P Sean, Lofaro, Lori R, Huang, Jing, Bhorade, Sangeeta M, Kennedy, Giulia C, Martinez, Fernando J, Raghu, Ganesh, Richeldi, Luca (ORCID:0000-0001-8594-1448), Richeldi, Luca, Scholand, Mary Beth, Lynch, David A, Colby, Thomas V, Myers, Jeffrey L, Groshong, Steve D, Chung, Jonathan H, Benzaquen, Sadia, Nathan, Steven D, Davis, J Russell, Schmidt, Shelley L, Hagmeyer, Lar, Sonetti, David, Hetzel, Jurgen, Criner, Gerard J, Case, Amy H, Ramaswamy, Murali, Calero, Karel, Gauhar, Umair A, Patel, Nina M, Lancaster, Lisa, Choi, Yoonha, Pankratz, Daniel G, Walsh, P Sean, Lofaro, Lori R, Huang, Jing, Bhorade, Sangeeta M, Kennedy, Giulia C, Martinez, Fernando J, Raghu, Ganesh, and Richeldi, Luca (ORCID:0000-0001-8594-1448)
Abstract: Rationale: Usual interstitial pneumonia (UIP) is the defining morphology of idiopathic pulmonary fibrosis (IPF). Guidelines for IPF diagnosis conditionally recommend surgical lung biopsy for histopathology diagnosis of UIP when radiology and clinical context are not definitive. A “molecular diagnosis of UIP” in transbronchial lung biopsy, the Envisia Genomic Classifier, accurately predicted histopathologic UIP. Objectives: We evaluated the combined accuracy of the Envisia Genomic Classifier and local radiology in the detection of UIP pattern. Methods: Ninety-six patients who had diagnostic lung pathology as well as a transbronchial lung biopsy for molecular testing with Envisia Genomic Classifier were included in this analysis. The classifier results were scored against reference pathology. UIP identified on high-resolution computed tomography (HRCT) as documented by features in local radiologists’ reports was compared with histopathology. Measurements and Main Results: In 96 patients, the Envisia Classifier achieved a specificity of 92.1% (confidence interval [CI],78.6–98.3%) and a sensitivity of 60.3% (CI, 46.6–73.0%) for histology-proven UIP pattern. Local radiologists identified UIP in 18 of 53 patients with UIP histopathology, with a sensitivity of 34.0% (CI, 21.5–48.3%) and a specificity of 96.9% (CI, 83.8–100%). In conjunction with HRCT patterns of UIP, the Envisia Classifier results identified 24 additional patients with UIP (sensitivity 79.2%; specificity 90.6%). Conclusions: In 96 patients with suspected interstitial lung disease, the Envisia Genomic Classifier identified UIP regardless of HRCT pattern. These results suggest that recognition of a UIP pattern by the Envisia Genomic Classifier combined with HRCT and clinical factors in a multidisciplinary discussion may assist clinicians in making an interstitial lung disease (especially IPF) diagnosis without the need for a surgical lung biopsy.
Published: 2021

217. Chest CT Diagnosis and Clinical Management of Drug-related Pneumonitis in Patients Receiving Molecular Targeting Agents and Immune Checkpoint Inhibitors: A Position Paper from the Fleischner Society

Author: Johkoh, Takeshi, Lee, Kyung Soo, Nishino, Mizuki, Travis, William D, Ryu, Jay H, Lee, Ho Yun, Ryerson, Christopher J, Franquet, Tomá, Bankier, Alexander A, Brown, Kevin K, Goo, Jin Mo, Kauczor, Hans-Ulrich, Lynch, David A, Nicholson, Andrew G, Richeldi, Luca, Schaefer-Prokop, Cornelia M, Verschakelen, Johny, Raoof, Suhail, Rubin, Geoffrey D, Powell, Charle, Inoue, Yoshikazu, Hatabu, Hiroto, Richeldi, Luca (ORCID:0000-0001-8594-1448), Johkoh, Takeshi, Lee, Kyung Soo, Nishino, Mizuki, Travis, William D, Ryu, Jay H, Lee, Ho Yun, Ryerson, Christopher J, Franquet, Tomá, Bankier, Alexander A, Brown, Kevin K, Goo, Jin Mo, Kauczor, Hans-Ulrich, Lynch, David A, Nicholson, Andrew G, Richeldi, Luca, Schaefer-Prokop, Cornelia M, Verschakelen, Johny, Raoof, Suhail, Rubin, Geoffrey D, Powell, Charle, Inoue, Yoshikazu, Hatabu, Hiroto, and Richeldi, Luca (ORCID:0000-0001-8594-1448)
Abstract: Use of molecular targeting agents and immune checkpoint inhibitors (ICIs) has increased the frequency and broadened the spectrum of lung toxicity, particularly in patients with cancer. The diagnosis of drug-related pneumonitis (DRP) is usually achieved by excluding other potential known causes. Awareness of the incidence and risk factors for DRP is becoming increasingly important. The severity of symptoms associated with DRP may range from mild or none to life-threatening with rapid progression to death. Imaging features of DRP should be assessed in consideration of the distribution of lung parenchymal abnormalities (radiologic pattern approach). The CT patterns reflect acute (diffuse alveolar damage) interstitial pneumonia and transient (simple pulmonary eosinophilia) lung abnormality, subacute interstitial disease (organizing pneumonia and hypersensitivity pneumonitis), and chronic interstitial disease (nonspecific interstitial pneumonia). A single drug can be associated with multiple radiologic patterns. Treatment of a patient suspected of having DRP generally consists of drug discontinuation, immunosuppressive therapy, or both, along with supportive measures eventually including supplemental oxygen and intensive care. In this position paper, the authors provide diagnostic criteria and management recommendations for DRP that should be of interest to radiologists, clinicians, clinical trialists, and trial sponsors, among others.
Published: 2021

218. Estimation of the Prevalence of Progressive Fibrosing Interstitial Lung Diseases: Systematic Literature Review and Data from a Physician Survey

Author: Olson, A., Hartmann, N., Patnaik, P., Wallace, L., Schlenker-Herceg, R., Nasser, M., Richeldi, L., Hoffmann-Vold, A. -M., Cottin, V., Richeldi L. (ORCID:0000-0001-8594-1448), Olson, A., Hartmann, N., Patnaik, P., Wallace, L., Schlenker-Herceg, R., Nasser, M., Richeldi, L., Hoffmann-Vold, A. -M., Cottin, V., and Richeldi L. (ORCID:0000-0001-8594-1448)
Abstract: Some patients with interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis exhibit a progressive clinical phenotype. These chronic progressive fibrosing ILDs have a variety of underlying diseases, and their prevalence is currently unknown. Here we carry out the first systematic review of literature on the prevalence of fibrosing ILDs and progressive fibrosing ILDs using data from physician surveys to estimate frequency of progression among different ILDs. We searched MEDLINE and Embase for studies assessing prevalence of ILD, individual ILDs associated with fibrosis and progressive fibrosing ILDs. These were combined with data from previously published physician surveys to obtain prevalence estimates of each chronic fibrosing ILD with a progressive phenotype and of progressive fibrosing ILDs overall. We identified 16 publications, including five reporting overall ILD prevalence, estimated at 6.3–76.0 per 100,000 people in Europe (four studies) and 74.3 per 100,000 in the USA (one study). In total, 13–40% of ILDs were estimated to develop a progressive fibrosing phenotype, with overall prevalence estimates for progressive fibrosing ILDs of 2.2–20.0 per 100,000 in Europe and 28.0 per 100,000 in the USA. Prevalence estimates for individual progressive fibrosing ILDs varied up to 16.7 per 100,000 people. These conditions represent a sizeable fraction of chronic respiratory disorders and have a high unmet need.
Published: 2021

219. Suggestions for lung function testing in the context of COVID-19

Author: Milanese, M., Corsico, A. G., Bellofiore, S., Carrozzi, L., Di Marco, F., Iovene, Bruno, Richeldi, Luca, Sanna, A., Santus, P., Schisano, M., Scichilone, N., Vancheri, C., Cerveri, I., Iovene B., Richeldi L. (ORCID:0000-0001-8594-1448), Milanese, M., Corsico, A. G., Bellofiore, S., Carrozzi, L., Di Marco, F., Iovene, Bruno, Richeldi, Luca, Sanna, A., Santus, P., Schisano, M., Scichilone, N., Vancheri, C., Cerveri, I., Iovene B., and Richeldi L. (ORCID:0000-0001-8594-1448)
Abstract: The 2019 coronavirus disease (COVID-19) pandemic is currently a challenge worldwide. Due to the characteristics of lung function tests, the risk of cross infection may be high between health care workers and patients. The role of lung function testing is well defined for the diagnosis of various diseases and conditions. Lung function tests are also indispensable in evaluating the response to medical treatment, in monitoring patient respiratory and systemic pathologies, and in evaluating preoperative risk in cardiothoracic and major abdominal surgeries. However, lung function testing represents a potential route for COVID-19 transmission, due to the aerosol generated during the procedures and the concentration of patients with pulmonary diseases in lung function laboratories. Currently, the opportunities for COVID-19 transmission remain partially unknown, and data are continuously evolving. This review provides useful information on the risks and recommendations for lung function testing, which have varied according to the phase of the pandemic. This information may support national and regional boards and the health authorities to which they belong. There is a need for rapid re-opening of lung function laboratories, but maximum safety is required in the COVID-19 era.
Published: 2021

220. Real-world experience with benralizumab in patients with severe eosinophilic asthma: A case series

Author: Menzella, F., Bonavia, M., Bonini, Matteo, D’Amato, M., Lombardo, S., Murgia, N., Patella, V., Triggiani, M., Pelaia, G., Bonini M. (ORCID:0000-0002-3042-0765), Menzella, F., Bonavia, M., Bonini, Matteo, D’Amato, M., Lombardo, S., Murgia, N., Patella, V., Triggiani, M., Pelaia, G., and Bonini M. (ORCID:0000-0002-3042-0765)
Published: 2021

221. ARIA‐EAACI care pathways for allergen immunotherapy in respiratory allergy

Author: Bousquet, Jean, Pfaar, Oliver, Agache, Ioana, Bedbrook, Anna, Akdis, Cezmi A, Canonica, Giorgio Walter, Chivato, Tomas, Al-Ahmad, Mona, Rasib, A. H. Abdul, Ansotegui, Ignacio J, Bachert, Claus, Soto-Martinez, Manuel, Laune, Daniel, Casale, Tomas, Levin, Michael, Larenas-Linnemann, Désirée, Samolinski, Boleslaw, Lodrup Carlsen, Karin C, O'Mahony, Liam, Lombardi, Carlo, Riggioni, Carmen, Hossny, Elham, Barata, Luís Taborda, Lourenço, Olga, Devillier, Philippe, Mahboub, Bassam, Malling, Hans-Jørgen, Sheikh, Aziz, Manning, Patrick, Passalacqua, Giovanni, Marshall, Gailen D, Sanchez-Borges, Mario, Toppila-Salmi, Sanna, Melén, Erik, Fokkens, Wytske J, Meltzer, Eli O, Miculinic, Neven, Soto-Quiros, Manuel, Milenkovic, Branislava, Roberts, Graham, Ohta, Ken, Scichilone, Nicola, Moin, Mostafa, Odemyr, Mikaëla, Montefort, Stephen, Almeida, Mário Morais, Bom, Ana Todo, Mortz, Charlotte G, Serpa, Faradiba S, Patella, Vincenzo, Sova, Milan, Mösges, Ralph, Mullol, Joaquim, Namazova Baranova, Leyla, Tsiligianni, Ioanna, Neffen, Hugo, Bjermer, Leif, Rodriguez-Gonzales, Monica, Torres, Maria J, Okamoto, Yoshitaka, Okubo, Kimi, Pajno, Giovanni B, Baharuddin, Abdullah, Cecchi, Lorenzo, Sastre, Joaquin, Untersmayr, Eva, Pawankar, Ruby, Pham-Thi, Nhân, Plavec, Davor, Cardona, Victoria, Dokic, Dejan, Sisul, Juan Carlos, Rosario, Nelson, Rottem, Menachem, Rouadi, Philip W, Del Giacco, Stefano, Fonseca, Joao A, Schwarze, Jürgen, Scadding, Glenis K, Shamji, Mohamed H, Schmid-Grendelmeier, Peter, Niedoszytko, Marek, Valentin-Rostan, Marylin, Sofiev, Mikhail, Solé, Dirceu, Sooronbaev, Talant, Palkonen, Susanna, Urrutia-Pereira, Marilyn, Skypala, Isabel, Suppli-Ulrik, Charlotte, Bonini, Matteo, Popov, Todor A, Tomazic, Peter-Valentin, Valero, Antonio, Cepeda Sarabia, Alfonso M, Ryan, Dermot, Bosnic-Anticevich, Sinthia, Valiulis, Arunas, Durham, Stephen L, Schünemann, Holger, Kalayci, Omer, Valovirta, Erkka, Panzner, Petr, Vandenplas, Olivier, Ventura, Maria Teresa, Gotua, Maia, Vichyanond, Pakit, Chkhartishvili, Ekaterine, Wagenmann, Martin, Fontaine, Jean-François, Kull, Inger, Wallace, Dana, Recto, Marysia, Walusiak-Skorupa, Jolanta, Wang, De Yun, Hrubiško, Martin, Waserman, Susan, Ebisawa, Motohiro, Bosse, Isabelle, Grisle, Ineta, Wong, Gary Wk, Bindslev-Jensen, Carsten, Yorgancioglu, Arzu, Yusuf, Osman M, Khaitov, Musa, Zernotti, Mario, Gawlik, Radoslaw, Chu, Derek K, Irani, Carla, Zhang, Luo, Zidarn, Mihaela, Zuberbier, Torsten, Kuna, Piotr, Jutel, Marek, Guzmán, Maria Antonieta, El-Gamal, Yehia, Klimek, Ludger, Brough, Helen A, Brussino, Luisa, Calderon, Moises A, Caraballo, Luis, O'Hehir, Robyn E, Gelincik, Asli, Kvedariene, Violeta, Cirule, Ieva, Cruz, Alvaro A, Czarlewski, Wienczyslawa, Nekam, Kristof, Papadopoulos, Nikolaos G., Haahtela, Tari, Emuzyte, Regina, Gamkrelidze, Amiran, Fauquert, Jean Luc, Palomares, Oscar, Regateiro, Frederico S, Ivancevich, Juan Carlos, Gemicioglu, Bilun, Gereda, Jose E, Gerth van Wijk, Roy, Bergmann, Karl-Christian, Knol, Edward, Halken, Susanne, Heffler, Enrico, Hoffmann-Sommergruber, Karin, Martins, Pedro Carreiro, Kritikos, Vicky, Ispayeva, Zhanat, Julge, Kaja, Kaidashev, Igor, Demoly, Pascal, Kowalski, Marek, Kraxner, Helga, Ollert, Markus, Fiocchi, Alessandro, Lauerma, Antti, Lau, Susanne, Park, Hae-Sim, Gomez, R Maximiliano, Comprehensive Health Research Centre (CHRC) - pólo NMS, Centro de Estudos de Doenças Crónicas (CEDOC), NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM), uBibliorum, Bousquet J., Pfaar O., Agache I., Bedbrook A., Akdis C.A., Canonica G.W., Chivato T., Al-Ahmad M., Abdul Latiff A.H., Ansotegui I.J., Bachert C., Baharuddin A., Bergmann K.-C., Bindslev-Jensen C., Bjermer L., Bonini M., Bosnic-Anticevich S., Bosse I., Brough H.A., Brussino L., Calderon M.A., Caraballo L., Cardona V., Carreiro-Martins P., Casale T., Cecchi L., Cepeda Sarabia A.M., Chkhartishvili E., Chu D.K., Cirule I., Cruz A.A., Czarlewski W., del Giacco S., Demoly P., Devillier P., Dokic D., Durham S.L., Ebisawa M., El-Gamal✝ Y., Emuzyte R., Gamkrelidze A., Fauquert J.L., Fiocchi A., Fokkens W.J., Fonseca J.A., Fontaine J.-F., Gawlik R., Gelincik A., Gemicioglu B., Gereda J.E., Gerth van Wijk R., Gomez R.M., Gotua M., Grisle I., Guzman M.-A., Haahtela T., Halken S., Heffler E., Hoffmann-Sommergruber K., Hossny E., Hrubisko M., Irani C., Ivancevich J.C., Ispayeva Z., Julge K., Kaidashev I., Kalayci O., Khaitov M., Klimek L., Knol E., Kowalski M.L., Kraxner H., Kull I., Kuna P., Kvedariene V., Kritikos V., Lauerma A., Lau S., Laune D., Levin M., Larenas-Linnemann D.E., Lodrup Carlsen K.C., Lombardi C., Lourenco O.M., Mahboub B., Malling H.-J., Manning P., Marshall G.D., Melen E., Meltzer E.O., Miculinic N., Milenkovic B., Moin M., Montefort S., Morais-Almeida M., Mortz C.G., Mosges R., Mullol J., Namazova Baranova L., Neffen H., Nekam K., Niedoszytko M., Odemyr M., O'Hehir R.E., Ollert M., O'Mahony L., Ohta K., Okamoto Y., Okubo K., Pajno G.B., Palomares O., Palkonen S., Panzner P., G Papadopoulos N., Park H.-S., Passalacqua G., Patella V., Pawankar R., Pham-Thi N., Plavec D., Popov T.A., Recto M., Regateiro F.S., Riggioni C., Roberts G., Rodriguez-Gonzales M., Rosario N., Rottem M., Rouadi P.W., Ryan D., Samolinski B., Sanchez-Borges✝ M., Serpa F.S., Sastre J., Scadding G.K., Shamji M.H., Schmid-Grendelmeier P., Schunemann H.J., Sheikh A., Scichilone N., Sisul J.C., Sofiev M., Sole D., Sooronbaev T., Soto-Martinez M., Soto-Quiros M., Sova M., Schwarze J., Skypala I., Suppli-Ulrik C., Taborda-Barata L., Todo-Bom A., Torres M.J., Valentin-Rostan M., Tomazic P.-V., Valero A., Toppila-Salmi S., Tsiligianni I., Untersmayr E., Urrutia-Pereira M., Valiulis A., Valovirta E., Vandenplas O., Ventura M.T., Vichyanond P., Wagenmann M., Wallace D., Walusiak-Skorupa J., Wang D.Y., Waserman S., Wong G.W.K., Yorgancioglu A., Yusuf O.M., Zernotti M., Zhang L., Zidarn M., Zuberbier T., Jutel M., HUS Inflammation Center, Department of Dermatology, Allergology and Venereology, University of Helsinki, Department of Pathology, Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Contre les MAladies Chroniques pour un VIeillissement Actif en Languedoc-Roussillon (MACVIA-LR), Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-European Innovation Partnership on Active and Healthy Ageing Reference Site (EIP on AHA), Commission Européenne-Commission Européenne-Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO), Philipps Universität Marburg = Philipps University of Marburg, Transilvania University of Brasov, Universität Zürich [Zürich] = University of Zurich (UZH), Humanitas University [Milan] (Hunimed), Universidad San Pablo CEU, Kuwait University, Al-Rashed Allergy Center [Kuwait City], Pantai Hospital [Kuala Lumpur], Hospital Quirónsalud Bizkaia [Bilbao], Ghent University Hospital, Karolinska Institutet [Stockholm], Karolinska University Hospital [Stockholm], Sun Yat-Sen University [Guangzhou] (SYSU), Universiti Sains Malaysia (USM), Humboldt University Of Berlin, Berlin Institute of Health (BIH), Odense University Hospital (OUH), Skane University Hospital [Lund], Fondazione Policlinico Universitario Agostino Gemelli IRCCS, National Heart and Lung Institute [London] (NHLI), Imperial College London-Royal Brompton and Harefield NHS Foundation Trust, Università cattolica del Sacro Cuore = Catholic University of the Sacred Heart [Roma] (Unicatt), Woolcock Institute of Medical Research [Sydney], The University of Sydney, Guy's and St Thomas' Hospital [London], King‘s College London, Università degli studi di Torino = University of Turin (UNITO), University of Cartagena, Vall d'Hebron University Hospital [Barcelona], Centro Hospitalar de Lisboa Central E.P.E, NOVA Medical School - Faculdade de Ciências Médicas (NMS), Universidade Nova de Lisboa = NOVA University Lisbon (NOVA)-Universidade Nova de Lisboa = NOVA University Lisbon (NOVA), University of South Florida [Tampa] (USF), Azienda Usl Toscana centro [Firenze], Universidad Simon Bolivar (USB), David Tvildiani Medical University (DTMU), McMaster University [Hamilton, Ontario], Children's Clinical University Hospital [Riga, Latvia] (CCUH), Universidade Federal da Bahia (UFBA), Università degli Studi di Cagliari = University of Cagliari (UniCa), Epidemiology of Allergic and Respiratory Diseases Department [iPlesp] (EPAR), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Institut Desbrest de santé publique (IDESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Hôpital Foch [Suresnes], Sagamihara National Hospital [Kanagawa, Japan], Université Ain Shams, Vilnius University [Vilnius], CHU Clermont-Ferrand, IRCCS Ospedale Pediatrico Bambino Gesù [Roma], Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA), European Forum for Research and Education in Allergy and Airway Diseases (EUFOREA), Universidade do Porto = University of Porto, Silesian Medical University, Katowice, Poland, Cerrahpasa Faculty of Medicine, Istanbul University, Erasmus University Medical Center [Rotterdam] (Erasmus MC), Universidad de Chile = University of Chile [Santiago] (UCHILE), Humanitas Clinical and Research Center [Rozzano, Milan, Italy], Medizinische Universität Wien = Medical University of Vienna, Hôtel-Dieu de France (HDF), Université Saint-Joseph de Beyrouth (USJ), Tartu University Hospital [Tartu, Estonia], Ukrainina Medical Stomatological Academy [Poltava, Ukraine], Hacettepe University = Hacettepe Üniversitesi, Università degli studi di Bari Aldo Moro = University of Bari Aldo Moro (UNIBA), Siriraj Hospital, Mahidol University, Mahidol University [Bangkok], Nova Southeastern University (NSU), Nofer Institute of Occupational Medicine (NIOM), National University of Singapore (NUS), Yong Loo Lin School of Medicine [Singapore], The Chinese University of Hong Kong [Hong Kong], Manisa Celal Bayar University, Universidad Nacional de Villa María, Universidad Católica de Córdoba, Beijing Tongren Hospital, Herrada, Anthony, UCL - SSS/IREC/PNEU - Pôle de Pneumologie, ORL et Dermatologie, and UCL - (MGD) Service de pneumologie
Subjects: Pulmonary and Respiratory Medicine, precision medicine, education, Immunology, Review, Settore MED/10 - Malattie Dell'Apparato Respiratorio, immune system diseases, HDE ALER, allergic rhinitis, asthma, immunotherapy, Medicine and Health Sciences, Immunology and Allergy, [SDV.IMM.ALL]Life Sciences [q-bio]/Immunology/Allergology, ComputingMilieux_MISCELLANEOUS, Rhinitis, RC581-607, respiratory tract diseases, 3121 General medicine, internal medicine and other clinical medicine, Immunologic diseases. Allergy, 600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit, [SDV.IMM.ALL] Life Sciences [q-bio]/Immunology/Allergology, allergic rhinitis, asthma, immunotherapy, precision medicine
Abstract: Funding Information: BSreports personal fees from Allergopharma, during the conduct of the study; grants from National Health Programm, grant, personal fees from Polpharma, ASTRA, personal fees from Mylan, Adamed, patient ombudsman, national Centre for Research and Development, Polish Allergology Society. Funding Information: NGP reports personal fees from Novartis, Nutricia, HAL, MENARINI/FAES FARMA, SANOFI, MYLAN/MEDA, BIOMAY, AstraZeneca, GSK, MSD, ASIT BIOTECH, Boehringer Ingelheim, grants from Gerolymatos International SA, Capricare. Funding Information: CA reports grants from Allergopharma, grants from Idorsia, Swiss National Science Foundation, Christine Kühne‐Center for Allergy Research and Education, European Commission's Horison's 2020 Framework Programme, Cure, Novartis Research Institutes, Astra Zeneca, scibase, advisory role in Sanofi/Regeneron, grants from Glakso Smith‐Kline, advisory role in scibase. Funding Information: MJTreports grants from European Commission, SEAIC, ISCIII, personal fees from Diater laboratory, Leti laboratory, Aimmune Therapeutics. Funding Information: LK reports grants and personal fees from Allergopharma, MEDA/Mylan, LETI Pharma, Sanofi, grants from Stallergenes, Quintiles, ASIT biotech, grants from ALK Abelló, Lofarma, AstraZeneca, GSK, Inmunotk, personal fees from Allergy Therapeut., HAL Allergie, Cassella med; and Membership: AeDA, DGHNO, Deutsche Akademie für Allergologie und klinische Immunologie, HNO‐BV, GPA, EAACI. Funding Information: DPreports grants and personal fees from GlaxoSmithKline, personal fees from Menarini, Pliva, Belupo, AbbVie, Novartis, MSD, Chiesi, Revenio, personal fees and non‐financial support from Boehringer Ingelheim, non‐financial support from Philips. Funding Information: OP reports grants and personal fees from ALK‐Abelló, Allergopharma, Stallergenes Greer, HAL Allergy Holding B.V./HAL Allergie GmbH, Bencard Allergie GmbH/Allergy Therapeutics, Lofarma, ASIT Biotech Tools S.A., Laboratorios LETI/LETI Pharma, Anergis S.A., Glaxo Smith Kline, grants from Biomay, Circassia, Pohl‐Boskamp, Inmunotek S.L., personal fees from MEDA Pharma/MYLAN, Mobile Chamber Experts (a GA2LEN Partner), Indoor Biotechnologies, Astellas Pharma Global, EUFOREA, ROXALL Medizin, Novartis, Sanofi‐Aventis and Sanofi‐Genzyme, Med Update Europe GmbH, streamedup! GmbH, John Wiley and Sons, AS. Copyright: Copyright 2021 Elsevier B.V., All rights reserved. publishersversion published
Published: 2021

222. Pattern of cancer patient referral and organisational model of an interventional pulmonology programme during the COVID-19 pandemic

Author: Rocco Trisolini, Vanina Livi, Fausto Leoncini, Maria C. Flore, Daniele Magnini, Giovanni Sotgiu, Daniela Paioli, and Lucia Maria Porro
Subjects: Pulmonary and Respiratory Medicine, 2019-20 coronavirus outbreak, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Original Research Letters, COVID-19, Cancer, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, medicine.disease, Interventional pulmonology, 03 medical and health sciences, Patient referral, 0302 clinical medicine, 030228 respiratory system, Emergency medicine, Pandemic, medicine, Medicine, 030212 general & internal medicine, business
Abstract: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and its related disease (coronavirus disease 2019 (COVID-19)) have heavily impacted cancer pathways, with population-based modelling studies predicting a substantial increase in the number of avoidable cancer deaths, mainly due to a diagnostic delay [1–3]. While the utility of bronchoscopy for the microbiological confirmation of the SARS-CoV-2 infection has been evaluated, the feasibility and safety of a diagnostic programme aimed at guaranteeing timely invasive procedures to patients with suspected or known thoracic malignancies during the COVID-19 pandemic has not yet been thoroughly assessed [4–6]. In a literature review, we found a single important study that described an organisational model for bronchoscopic procedures during the first wave of the pandemic, when no published guidelines were available [7]. However, it could not analyse the referral pattern over time as it covered a short time frame (2 months), included a relatively small number of cancer patients (126), and did not detail how patients and staff were screened for the SARS-CoV-2 infection [7]., An interventional pulmonary programme can be carried out safely for both cancer patients and HCWs during the #COVID19 pandemic. However, a worrisome reduction of new cancer patient referral occurs during periods of high community spread of the virus. https://bit.ly/2PRWNXo
Published: 2021

223. A Key to Unlocking the Mysteries of COVID-19 Pulmonary Sequelae: Are We There?

Author: Claudia Crimi, Nicola Scichilone, Crimi C., and Scichilone N.
Subjects: Pulmonary and Respiratory Medicine, Coronavirus disease 2019, Score, Coronavirus disease 2019, Pulmonary sequelae, Score, Pulmonary sequelae, Settore MED/10 - Malattie Dell'Apparato Respiratorio
Abstract: N/A
Published: 2022

224. The 2018 Diagnosis of Idiopathic Pulmonary Fibrosis Guidelines: Surgical Lung Biopsy for Radiological Pattern of Probable Usual Interstitial Pneumonia Is Not Mandatory

Author: Martine Remy-Jardin, Ganesh Raghu, Kevin C. Wilson, Jeffrey L. Myers, and Luca Richeldi
Subjects: Pulmonary and Respiratory Medicine, medicine.medical_specialty, Biopsy, MEDLINE, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, Lung biopsy, Critical Care and Intensive Care Medicine, 030218 nuclear medicine & medical imaging, 03 medical and health sciences, Idiopathic pulmonary fibrosis, 0302 clinical medicine, Usual interstitial pneumonia, Humans, Medicine, medicine.diagnostic_test, business.industry, Patient Selection, Editorials, medicine.disease, Idiopathic Pulmonary Fibrosis, IPF, 030228 respiratory system, Radiological weapon, Practice Guidelines as Topic, Radiology, business
Published: 2019

225. Outcomes following decline in forced vital capacity in patients with idiopathic pulmonary fibrosis: Results from the INPULSIS and INPULSIS-ON trials of nintedanib

Author: Moisés Selman, Luca Richeldi, Vincent Cottin, Bruno Crestani, Susanne Stowasser, Martin Kolb, Manuel Quaresma, Arata Azuma, and Wibke Stansen
Subjects: Pulmonary and Respiratory Medicine, medicine.medical_specialty, Vital capacity, Indoles, Vital Capacity, Interstitial lung disease, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, 03 medical and health sciences, chemistry.chemical_compound, FEV1/FVC ratio, Idiopathic pulmonary fibrosis, 0302 clinical medicine, Internal medicine, medicine, Humans, In patient, 030212 general & internal medicine, business.industry, respiratory system, medicine.disease, Idiopathic Pulmonary Fibrosis, respiratory tract diseases, Treatment Outcome, 030228 respiratory system, chemistry, Cardiology, Nintedanib, business, circulatory and respiratory physiology
Abstract: We explored the impact of FVC decline on subsequent FVC decline and mortality in the INPULSIS trials of nintedanib in patients with IPF and their open-label extension, INPULSIS-ON.Changes in FVC and mortality between weeks 24 and 52 of the INPULSIS trials were assessed in patients with an increase/no decline in FVC % predicted and with declines in FVC10% and ≥10% predicted from baseline to week 24. Changes in FVC and mortality in the first year of INPULSIS-ON were assessed in patients treated with nintedanib in the preceding INPULSIS trial who did and did not have a decline in FVC ≥10% predicted at week 52.The proportion of placebo-treated patients with decline in FVC ≥10% predicted between weeks 24 and 52 of INPULSIS was similar in patients with increase/no decline in FVC and with decline in FVC ≥10% predicted between baseline and week 24 (20.5% and 18.9%, respectively). Mortality between weeks 24 and 52 of INPULSIS was higher in patients with FVC decline ≥10% predicted than10% predicted between baseline and week 24 (13.2% vs 3.8%). Among nintedanib-treated patients in INPULSIS who had decline in FVC ≥10% versus10% predicted at week 52, 34.0% versus 21.4%, respectively, had decline in FVC ≥10% predicted in the first year of INPULSIS-ON. Mortality in the first year of INPULSIS-ON was 21.3% vs 5.7% in these groups, respectively.Decline in FVC did not predict FVC decline but was associated with mortality in patients with IPF.
Published: 2019

226. Long-term treatment with recombinant human pentraxin 2 protein in patients with idiopathic pulmonary fibrosis: an open-label extension study

Author: A. Whitney Brown, Renu Gupta, Ganesh Raghu, Luca Richeldi, Mark J. Hamblin, Lawrence A. Ho, Marlies S. Wijsenbeek, Bernt van den Blink, Jeffrey A. Golden, Hugues Santin-Janin, Michael Kreuter, Geert-Jan Mulder, Martina Vasakova, Danielle Antin-Ozerkis, Francois Aubin, Keith C. Meyer, Donna Moran, Alberto Pesci, Raghu, G, van den Blink, B, Hamblin, M, Brown, A, Golden, J, Ho, L, Wijsenbeek, M, Vasakova, M, Pesci, A, Antin-Ozerkis, D, Meyer, K, Kreuter, M, Moran, D, Santin-Janin, H, Aubin, F, Mulder, G, Gupta, R, Richeldi, L, and Pulmonary Medicine
Subjects: Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Exacerbation, Vital Capacity, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, Placebo, law.invention, 03 medical and health sciences, FEV1/FVC ratio, Idiopathic pulmonary fibrosis, 0302 clinical medicine, Double-Blind Method, Randomized controlled trial, law, Internal medicine, Humans, Medicine, 030212 general & internal medicine, Extensive stage, Aged, idiopathic pulmonary fibrosis, pentraxin 2, Homeodomain Proteins, Cross-Over Studies, MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, business.industry, medicine.disease, Long-Term Care, Crossover study, Idiopathic Pulmonary Fibrosis, Recombinant Proteins, Serum Amyloid P-Component, Treatment Outcome, 030228 respiratory system, Tolerability, Female, idiopathic pulmonary fibrosis (IPF), business
Abstract: Background: Patients with idiopathic pulmonary fibrosis (IPF) treated with PRM-151, a recombinant human pentraxin 2 protein, in a phase 2 double-blind, randomised controlled trial had significantly reduced decline in percentage of predicted forced vital capacity (FVC) and stabilised 6-min walking distance compared with placebo over a 28-week period. Here we report the 76-week results of an open-label extension study. Methods: Patients who completed the 28-week double-blind period of the PRM-151-202 trial were eligible to participate in the open-label extension study. Patients previously enrolled in the PRM-151 group continued this treatment and those previously in the placebo group crossed over to PRM-151. All patients received PRM-151 in 28-week cycles with loading doses of 10 mg/kg by 60 min intravenous infusions on days 1, 3, and 5 in the first week of each cycle followed by one infusion of 10 mg/kg every 4 weeks. The primary objective of the open-label extension study was to assess the long-term safety and tolerability of PRM-151, which were assessed by analysing adverse events (AEs) up to week 76 in all patients who received at least one dose of PRM-151 during the open-label extension study. Exploratory efficacy analyses were done by assessing changes from baseline in percentage of predicted FVC and 6-min walking distance, with descriptive statistics to week 76 and with random-intercept mixed models to week 52. This study is registered with ClinicalTrials.gov, number NCT02550873, and with EudraCT, number 2014-004782-24. Findings: Of 116 patients who completed the double-blind treatment period, 111 entered the open-label extension study (74 from the PRM-151 group and 37 from the placebo group). 84 (76%) of 111 patients received concomitant IPF therapy (pirfenidone n=55 or nintedanib n=29). AEs were consistent with long-term IPF sequelae. 31 (28%) patients had serious AEs. Those occurring in two or more patients were pneumonia (six [5%] of 111), IPF exacerbation (four [4%]), IPF progression (four [4%]), and chest pain (two [2%]). 21 (19%) patients had severe AEs, of which IPF exacerbation and IPF progression each occurred in two (2%) patients. Two (2%) patients experienced life-threatening AEs (one had pneumonia and one had small-cell lung cancer extensive stage). A persistent treatment effect was observed for PRM-151 in patients who continued treatment, with a decline in percentage of predicted FVC of −3·6% per year and in 6-min walking distance of −10·5 m per year at week 52. In patients who started PRM-151 during the open-label extension study, compared with the slopes for placebo, decline reduced for percentage of predicted FVC (from −8·7% per year in weeks 0–28 to −0·9% per year in weeks 28–52, p
Published: 2019

227. Evolving Concepts in Chronic Obstructive Pulmonary Disease Blood-Based Biomarkers

Author: Ermanno Puxeddu, Paola Rogliani, Josuel Ora, and Mario Cazzola
Subjects: 0301 basic medicine, medicine.medical_specialty, Settore MED/10 - Malattie dell'Apparato Respiratorio, Medical laboratory, Pulmonary Disease, Chronic Obstructive, 03 medical and health sciences, 0302 clinical medicine, Pharmacotherapy, Drug Development, Diabetes mellitus, Genetics, medicine, Humans, Liquid biopsy, Intensive care medicine, Pharmacology, COPD, business.industry, Liquid Biopsy, Computational Biology, Fibrinogen, General Medicine, Prognosis, medicine.disease, respiratory tract diseases, 030104 developmental biology, Molecular Diagnostic Techniques, Drug development, 030220 oncology & carcinogenesis, Meta-analysis, Molecular Medicine, Biomarker (medicine), Disease Susceptibility, business, Biomarkers
Abstract: In recent years, there has been a great deal of interest in the identification and validation of blood-based biomarkers for clinical use in chronic obstructive pulmonary disease (COPD). We now have panels of blood biomarkers that potentially hold great promise as they show statistically significant associations with COPD, but biomarkers for the diagnosis of COPD remain elusive. In fact, they are yet to demonstrate sufficient accuracy to be accepted in clinical use, and many are not specific to COPD but more related to inflammation (e.g. interleukin-6) or associated with other chronic diseases such as diabetes (e.g. soluble receptor for advanced glycation endproducts [sRAGE]). Although no single blood-based biomarker has demonstrated clinical utility for either the diagnosis or progression of COPD, it has been suggested that combinations of individual markers may provide important diagnostic or prognostic information; however, the interpretation of COPD biomarker results still requires thought and many questions remain unanswered.
Published: 2019

228. Thiol-Based Drugs in Pulmonary Medicine: Much More than Mucolytics

Author: Mario Cazzola, Luigino Calzetta, Clive P. Page, Maria Gabriella Matera, Paola Rogliani, Cazzola, M., Calzetta, L., Page, C., Rogliani, P., and Matera, M. G.
Subjects: 0301 basic medicine, Lung Neoplasms, Antioxidant, Settore MED/10 - Malattie dell'Apparato Respiratorio, medicine.medical_treatment, Thiophenes, thiol-based drugs, Pharmacology, Toxicology, medicine.disease_cause, Antioxidants, anti-inflammatory agents, antioxidant drugs, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, mucolytics, Pulmonary medicine, Pulmonary Medicine, medicine, Animals, Humans, COPD, Sulfhydryl Compounds, Respiratory system, Expectorants, chemistry.chemical_classification, Biofilm, Glutathione, anti-inflammatory agent, antioxidant drug, IPF, 030104 developmental biology, chemistry, Thioglycolates, Thiol, mucolytic, Neurokinin A, 030217 neurology & neurosurgery, Oxidative stress
Abstract: Thiol-based drugs are considered as mucolytics because they decrease the viscosity and mostly decrease the elasticity of bronchial secretions by reducing disulfide bonds in proteins. However, they can also act as antioxidant drugs directly through free sulfhydryl groups that serve as a source of reducing equivalents, as well as indirectly through the replenishment of intracellular glutathione (GSH) levels. Modulation of neurokinin A levels may also be related to the effect of thiol drugs on oxidative stress. Moreover, thiol-based drugs interfere with inflammatory pathways and modulate human bronchial tone. They might also be considered as therapeutic agents against some types of infection because they reduce bacterial adhesion to the respiratory epithelial cell surface and inhibit biofilm formation, causing biofilm disruption and thereby improving the efficacy of antibiotic therapy.
Published: 2019

229. Pharmacological characterization of the interaction between tiotropium bromide and olodaterol on human bronchi and small airways

Author: Barbara Rinaldi, Clive P. Page, Luigino Calzetta, Mario Cazzola, Maria Gabriella Matera, Paola Rogliani, Calzetta, L, Rogliani, P, Page, C, Rinaldi, B, Cazzola, M, and Matera, Mg.
Subjects: Male, Pulmonary and Respiratory Medicine, Carbachol, Human airways, Settore MED/10 - Malattie dell'Apparato Respiratorio, Bronchi, Muscarinic Antagonists, Pharmacology, Contractility, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Muscarinic acetylcholine receptor, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Adrenergic beta-2 Receptor Agonists, Aged, Papaverine, Chemistry, Biochemistry (medical), Olodaterol, Muscarinic antagonist, Drug Synergism, Muscle, Smooth, Tiotropium bromide, Middle Aged, respiratory system, Synergy, Benzoxazines, Bronchodilator Agents, respiratory tract diseases, Drug Combinations, 030228 respiratory system, Female, Acetylcholine, medicine.drug
Abstract: Combining a long-acting β2-agonist (LABA) with a long-acting muscarinic antagonist (LAMA) is the cornerstone to treat patients with chronic obstructive pulmonary disease (COPD). In this study we have characterized the interaction between the LAMA tiotropium bromide, and the LABA olodaterol, on the contractile tone of human medium bronchi and small airways. The response to a combination of tiotropium bromide and olodaterol was assessed at sub-maximal contractile tone induced by carbachol. The duration of action was studied in tissue contracted by transmural stimulation. Relaxation of bronchial tone was expressed as % of maximal response to papaverine. Drug interactions were analyzed by the Bliss Independence method and Unified Theory. Tiotropium bromide/olodaterol combination induced a significant synergistic relaxant response (P < 0.05 vs. expected additive effect) in medium bronchi and small airways pre-contracted by carbachol, by enhancing relaxation +22.13 ± 4.42% and +26.31 ± 12.39%, respectively. The combination of tiotropium bromide and olodaterol also reduced the airway smooth muscle contractility elicited by transmural stimulation by 73.60 ± 3.10%. The extent of synergy was strong to very strong, and was supported by the release of neuronal acetylcholine, cyclic adenosine monophosphate levels, and activation of iberiotoxin-sensitive KCa++ channels. Conversely, the interaction between tiotropium bromide and olodaterl was independent of the activity at M2 muscarinic receptors. These results indicate that tiotropium bromide/olodaterol combination leads to a potent and durable synergistic relaxation of human medium bronchi and small airways. Further pharmacological studies are needed to confirm these results in clinical settings.
Published: 2019

230. Contemporary Concise Review 2018: Interstitial lung disease

Author: Mark Jones, Luca Richeldi, and Pier-Valerio Mari
Subjects: Pulmonary and Respiratory Medicine, Pathology, medicine.medical_specialty, business.industry, Interstitial lung disease, MEDLINE, hypersensitivity pneumonitis, interstitial lung disease, pulmonary fibrosis, sarcoidosis, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, medicine.disease, Pulmonary fibrosis, medicine, Sarcoidosis, business, Hypersensitivity pneumonitis
Published: 2019

231. Current and Future Idiopathic Pulmonary Fibrosis Therapy

Author: Luca Richeldi, Giuliana Pasciuto, Loredana Panico, Fabiana Baldi, and Francesco Macagno
Subjects: medicine.medical_specialty, Indoles, Pyridones, Nintedanib, Anti-Inflammatory Agents, Idiopathic pulmonary fibrosis, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, Disease, 030204 cardiovascular system & hematology, Pirfenidone, law.invention, 03 medical and health sciences, chemistry.chemical_compound, Clinical trials, 0302 clinical medicine, Randomized controlled trial, law, Humans, Medicine, 030212 general & internal medicine, Intensive care medicine, Disease Progression, Idiopathic Pulmonary Fibrosis, Therapeutic strategy, business.industry, Disease progression, General Medicine, medicine.disease, respiratory tract diseases, Clinical trial, chemistry, business, medicine.drug
Abstract: The last years have led to advances in the therapeutic management of idiopathic pulmonary fibrosis (IPF), mainly through the discovery of new pathological pathways and drugs and better design of clinical trials. The objective of this review is both to describe the current therapies approved for the treatment of IPF and the emerging therapeutic approaches. Currently, nintedanib and pirfenidone are the basis of IPF therapy, based on the results of large randomized clinical trials showing their safety and efficacy in reducing disease progression. Nonetheless, the ideal IPF therapy is still lacking and trials are underway to test new therapeutic targets. The near future could bring to clinicians and patients a combined therapeutic strategy, hitting the disease from several simultaneous pathways and hopefully leading to clinical stabilization or improvement.
Published: 2019

232. Bronchodilators in subjects with asthma-related comorbidities

Author: Mario Cazzola, Luigino Calzetta, Paola Rogliani, Maria Gabriella Matera, Cazzola, M., Rogliani, P., Calzetta, L., and Matera, M. G.
Subjects: Pulmonary and Respiratory Medicine, Muscarinic agonists, medicine.medical_specialty, Settore MED/10 - Malattie dell'Apparato Respiratorio, Osteoporosis, β, Disease, Anxiety, Xanthine, Comorbidities, Death, Sudden, 03 medical and health sciences, 0302 clinical medicine, immune system diseases, Internal medicine, Diabetes mellitus, Diabetes Mellitus, Humans, Medicine, Asthma, Xanthines, β(2)-agonists, Obesity, 030212 general & internal medicine, Depression (differential diagnoses), Depression, business.industry, agonists, medicine.disease, Rhinitis, Allergic, Bronchodilator Agents, respiratory tract diseases, 030228 respiratory system, Cardiovascular Diseases, Gastroesophageal Reflux, Muscarinic agonist, Narrative review, Comorbiditie, business
Abstract: Asthma is often associated with different comorbidities such as cardiovascular diseases, depression, diabetes mellitus, dyslipidaemia, osteoporosis, rhinosinusitis and mainly gastro-oesophageal reflux disease and allergic rhinitis. Although bronchodilators play an important role in the treatment of asthma, there is no overall description of their impact on comorbid asthma, regardless of whether favourable or negative. This narrative review examines the potential effects of bronchodilators on comorbidities of asthma.
Published: 2019

233. Prevalence and Etiology of Community-acquired Pneumonia in Immunocompromised Patients

Author: Di Pasquale, Marta Francesca, Sotgiu, Giovanni, Gramegna, Andrea, Radovanovic, Dejan, Terraneo, Silvia, Reyes, Luis F, Rupp, Jan, González del Castillo, Juan, Blasi, Francesco, Aliberti, Stefano, Restrepo, Marcos I, Aruj, Patricia Karina, Attorri, Silvia, Barimboim, Enrique, Caeiro, Juan Pablo, Garzón, María I, Cambursano, Victor Hugo, Cazaux, A, Ceccato, Adrian, Chertcoff, Julio, Lascar, Florencia, Tulio, Fernando Di, Díaz, Ariel Cordon, de Vedia, Lautaro, Ganaha, Maria Cristina, Lambert, Sandra, Lopardo, Gustavo, Luna, Carlos M, Malberti, Alessio Gerardo, Morcillo, Nora, Tartara, Silvina, Cetrangolo, Antonio A, Pensotti, Claudia, Pereyra, Betiana, Scapellato, Pablo Gustavo, Stagnaro, Juan Pablo, Shah, Sonali, Lötsch, Felix, Thalhammer, Florian, Anseeuw, Kurt, Francois, Camille A, Van Braeckel, Eva, Vincent, Jean Louis, Djimon, Marcel Zannou, Bashi, Jules, Dodo, Roger, Nouér, Simone Aranha, Chipev, Peter, Encheva, Milena, Miteva, Darina, Petkova, Diana, Balkissou, Adamou Dodo, Yone, Eric Walter Pefura, Ngahane, Bertrand Hugo Mbatchou, Shen, Ning, Xu, Jin-fu, Rico, Carlos Andres Bustamante, Buitrago, Ricardo, Paternina, Fernando Jose Pereira, Ntumba, Jean-Marie Kayembe, Carevic, Vesna Vladic, Jakopovic, Marko, Jankovic, Mateja, Matkovic, Zinka, Mitrecic, Ivan, Jacobsson, Marie-Laure Bouchy, Christensen, Anette Bro, Bødtger, Uffe Christian Heitmann, Meyer, Christian Niels, Jensen, Andreas Vestergaard, Baunbæk-Knudsen, Gertrud, Petersen, Pelle Trier, Andersen, Stine, El-Wahhab, Ibrahim El-Said Abd, Morsy, Nesreen Elsayed, Shafiek, Hanaa, Sobh, Eman, Abdulsemed, Kedir Abdella, Bertrand, Fabrice, Brun-Buisson, Christian, de Montmollin, Etienne, Fartoukh, Muriel, Messika, Jonathan, Tattevin, Pierre, Khoury, Abdo, Ebruke, Bernard, Dreher, Michael, Kolditz, Martin, Meisinger, Matthias, Niederlausitz, Klinikum, Pletz, Mathias W, Hagel, Stefan, Schaberg, Tom, Spielmanns, Marc, Creutz, Petra, Suttorp, Norton, Siaw-Lartey, Beatrice, Dimakou, Katerina, Papapetrou, Dimosthenis, Tsigou, Evdoxia, Ampazis, Dimitrios, Kaimakamis, Evangelos, Bhatia, Mohit, Dhar, Raja, D’Souza, George, Garg, Rajiv, Koul, Parvaiz A, Mahesh, P A, Jayaraj, B S, Narayan, Kiran Vishnu, Udnur, Hirennappa B, Krishnamurthy, Shashi Bhaskara, Kant, Surya, Swarnakar, Rajesh, Limaye, Sneha, Salvi, Sundeep, Golshani, Keihan, Keatings, Vera M, Martin-Loeches, Ignacio, Maor, Yasmin, Strahilevitz, Jacob, Battaglia, Salvatore, Carrabba, Maria, Ceriana, Piero, Confalonieri, Marco, Monforte, Antonella d’Arminio, Prato, Bruno Del, Rosa, Marino De, Fantini, Riccardo, Fiorentino, Giuseppe, Gammino, Maria Antonia, Menzella, Francesco, Milani, Giuseppe, Nava, Stefano, Palmiero, Gerardo, Petrino, Roberta, Gabrielli, Barbra, Rossi, Paolo, Sorino, Claudio, Steinhilber, Gundi, Zanforlin, Alessandro, Franzetti, Fabio, Carugati, Manuela, Morosi, Manuela, Monge, Elisa, Carone, Mauro, Patella, Vincenzo, Scarlata, Simone, Comel, Andrea, Kurahashi, Kiyoyasu, Bacha, Zeina Aoun, Ugalde, Daniel Barajas, Zuñiga, Omar Ceballos, Villegas, José F, Medenica, Milic, van de Garde, E M W, Mihsra, Deebya Raj, Shrestha, Poojan, Ridgeon, Elliott, Awokola, Babatunde Ishola, Nwankwo, Ogonna N O, Olufunlola, Adefuye Bolanle, Olumide, Segaolu, Ukwaja, Kingsley N, Irfan, Muhammad, Minarowski, Lukasz, Szymon, Skoczyński, Froes, Felipe, Leuschner, Pedro, Meireles, Mariana, Ferrão, Cláudia, Neves, João, Ravara, Sofia B, Brocovschii, Victoria, Ion, Chesov, Rusu, Doina, Toma, Cristina, Chirita, Daniela, Dorobat, Carmen Mihaela, Birkun, Alexei, Kaluzhenina, Anna, Almotairi, Abdullah, Bukhary, Zakeya Abdulbaqi Ali, Edathodu, Jameela, Fathy, Amal, Enani, Abdullah Mushira Abdulaziz, Mohamed, Nazik Eltayeb, Memon, Jawed Ulhadi, Bella, Abdelhaleem, Bogdanović, Nada, Milenkovic, Branislava, Pesut, Dragica, Borderìas, Luis, Garcia, Noel Manuel Bordon, Alarcón, Hugo Cabello, Cilloniz, Catia, Torres, Antoni, Diaz-Brito, Vicens, Casas, Xavier, González, Alicia Encabo, Fernández-Almira, Maria Luisa, Gallego, Miguel, Gaspar-GarcÍa, Inmaculada, del Castillo, Juan González, Victoria, Patricia Javaloyes, Martínez, Elena Laserna, de Molina, Rosa Malo, Marcos, Pedro J, Menéndez, Rosario, Pando-Sandoval, Ana, Aymerich, Cristina Prat, de la Torre, Alicia Lacoma, García-Olivé, Ignasi, Rello, Jordi, Moyano, Silvia, Sanz, Francisco, Sibila, Oriol, Rodrigo-Troyano, Ana, Solé-Violán, Jordi, Uranga, Ane, van Boven, Job F M, Torra, Ester Vendrell, Pujol, Jordi Almirall, Feldman, Charles, Yum, Ho Kee, Fiogbe, Arnauld Attannon, Yangui, Ferdaous, Bilaceroglu, Semra, Dalar, Levent, Yilmaz, Ufuk, Bogomolov, Artemii, Elahi, Naheed, Dhasmana, Devesh J, Feneley, Andrew, Ions, Rhiannon, Skeemer, Julie, Woltmann, Gerrit, Hancock, Carole, Hill, Adam T, Rudran, Banu, Ruiz-Buitrago, Silvia, Campbell, Marion, Whitaker, Paul, Youzguin, Alexander, Singanayagam, Anika, Allen, Karen S, Brito, Veronica, Dietz, Jessica, Dysart, Claire E, Kellie, Susan M, Franco-Sadud, Ricardo A, Meier, Garnet, Gaga, Mina, Holland, Thomas L, Bergin, Stephen P, Kheir, Fayez, Landmeier, Mark, Lois, Manuel, Nair, Girish B, Patel, Hemali, Reyes, Katherine, Rodriguez-Cintron, William, Saito, Shigeki, Soni, Nilam J, Noda, Julio, Hinojosa, Cecilia I, Levine, Stephanie M, Angel, Luis F, Anzueto, Antonio, Whitlow, K Scott, Hipskind, John, Sukhija, Kunal, Totten, Vicken, Wunderink, Richard G, Shah, Ray D, Mateyo, Kondwelani John, Noriega, Lorena, Alvarado, Ezequiel, Aman, Mohamed, Labra, Lucía, Value, Affordability and Sustainability (VALUE), Groningen Research Institute for Asthma and COPD (GRIAC), Di Pasquale, M. F., Sotgiu, G., Gramegna, A., Radovanovic, D., Terraneo, S., Reyes, L. F., Rupp, J., Gonzalez Del Castillo, J., Blasi, F., Aliberti, S., Restrepo, M. I., Aruj, P. K., Attorri, S., Barimboim, E., Caeiro, J. P., Garzon, M. I., Cambursano, V. H., Cazaux, A., Ceccato, A., Chertcoff, J., Lascar, F., Tulio, F. D., Diaz, A. C., de Vedia, L., Ganaha, M. C., Lambert, S., Lopardo, G., Luna, C. M., Malberti, A. G., Morcillo, N., Tartara, S., Cetrangolo, A. A., Pensotti, C., Pereyra, B., Scapellato, P. G., Stagnaro, J. P., Shah, S., Lotsch, F., Thalhammer, F., Anseeuw, K., Francois, C. A., Van Braeckel, E., Vincent, J. L., Djimon, M. Z., Bashi, J., Dodo, R., Nouer, S. A., Chipev, P., Encheva, M., Miteva, D., Petkova, D., Balkissou, A. D., Yone, E. W. P., Ngahane, B. H. M., Shen, N., Xu, J. F., Rico, C. A. B., Buitrago, R., Paternina, F. J. P., Ntumba, J. K., Carevic, V. V., Jakopovic, M., Jankovic, M., Matkovic, Z., Mitrecic, I., Jacobsson, M. B., Christensen, A. B., Bodtger, U. C. H., Meyer, C. N., Jensen, A. V., Baunbaek-Knudsen, G., Petersen, P. T., Andersen, S., El-Wahhab, I. E. A., Morsy, N. E., Shafiek, H., Sobh, E., Abdulsemed, K. A., Bertrand, F., Brun-Buisson, C., de Montmollin, E., Fartoukh, M., Messika, J., Tattevin, P., Khoury, A., Ebruke, B., Dreher, M., Kolditz, M., Meisinger, M., Niederlausitz, K., Pletz, M. W., Hagel, S., Schaberg, T., Spielmanns, M., Creutz, P., Suttorp, N., Siaw-Lartey, B., Dimakou, K., Papapetrou, D., Tsigou, E., Ampazis, D., Kaimakamis, E., Bhatia, M., Dhar, R., D'Souza, G., Garg, R., Koul, P. A., Mahesh, P. A., Jayaraj, B. S., Narayan, K. V., Udnur, H. B., Krishnamurthy, S. B., Kant, S., Swarnakar, R., Limaye, S., Salvi, S., Golshani, K., Keatings, V. M., Martin-Loeches, I., Maor, Y., Strahilevitz, J., Battaglia, S., Carrabba, M., Ceriana, P., Confalonieri, M., Monforte, A. D., Prato, B. D., Rosa, M., Fantini, R., Fiorentino, G., Gammino, M. A., Menzella, F., Milani, G., Nava, S., Palmiero, G., Petrino, R., Gabrielli, B., Rossi, P., Sorino, C., Steinhilber, G., Zanforlin, A., Franzetti, F., Carugati, M., Morosi, M., Monge, E., Carone, M., Patella, V., Scarlata, S., Comel, A., Kurahashi, K., Bacha, Z. A., Ugalde, D. B., Zuniga, O. C., Villegas, J. F., Medenica, M., van de Garde, E. M. W., Mihsra, D. R., Shrestha, P., Ridgeon, E., Awokola, B. I., Nwankwo, O. N. O., Olufunlola, A. B., Olumide, S., Ukwaja, K. N., Irfan, M., Minarowski, L., Szymon, S., Froes, F., Leuschner, P., Meireles, M., Ferrao, C., Neves, J., Ravara, S. B., Brocovschii, V., Ion, C., Rusu, D., Toma, C., Chirita, D., Dorobat, C. M., Birkun, A., Kaluzhenina, A., Almotairi, A., Bukhary, Z. A. A., Edathodu, J., Fathy, A., Enani, A. M. A., Mohamed, N. E., Memon, J. U., Bella, A., Bogdanovic, N., Milenkovic, B., Pesut, D., Borderias, L., Garcia, N. M. B., Alarcon, H. C., Cilloniz, C., Torres, A., Diaz-Brito, V., Casas, X., Gonzalez, A. E., Fernandez-Almira, Ml., Gallego, M., Gaspar-GarcIa, I., Victoria, P. J., Martinez, E. L., de Molina, R. M., Marcos, P. J., Menendez, R., Pando-Sandoval, A., Aymerich, C. P., de la Torre, A. L., Garcia-Olive, I., Rello, J., Moyano, S., Sanz, F., Sibila, O., Rodrigo-Troyano, A., Sole-Violan, J., Uranga, A., van Boven, J. F. M., Torra, E. V., Pujol, J. A., Feldman, C., Yum, H. K., Fiogbe, A. A., Yangui, F., Bilaceroglu, S., Dalar, L., Yilmaz, U., Bogomolov, A., Elahi, N., Dhasmana, D. J., Feneley, A., Ions, R., Skeemer, J., Woltmann, G., Hancock, C., Hill, A. T., Rudran, B., Ruiz-Buitrago, S., Campbell, M., Whitaker, P., Youzguin, A., Singanayagam, A., Allen, K. S., Brito, V., Dietz, J., Dysart, C. E., Kellie, S. M., Franco-Sadud, R. A., Meier, G., Gaga, M., Holland, T. L., Bergin, S. P., Kheir, F., Landmeier, M., Lois, M., Nair, G. B., Patel, H., Reyes, K., Rodriguez-Cintron, W., Saito, S., Soni, N. J., Noda, J., Hinojosa, C. I., Levine, S. M., Angel, L. F., Anzueto, A., Whitlow, K. S., Hipskind, J., Sukhija, K., Totten, V., Wunderink, R. G., Shah, R. D., Mateyo, K. J., Noriega, L., Alvarado, E., Aman, M., Labra, L., Di Pasquale M.F., Sotgiu G., Gramegna A., Radovanovic D., Terraneo S., Reyes L.F., Rupp J., Gonzalez Del Castillo J., Blasi F., Aliberti S., Restrepo M.I., Aruj P.K., Attorri S., Barimboim E., Caeiro J.P., Garzon M.I., Cambursano V.H., Cazaux A., Ceccato A., Chertcoff J., Lascar F., Tulio F.D., Diaz A.C., de Vedia L., Ganaha M.C., Lambert S., Lopardo G., Luna C.M., Malberti A.G., Morcillo N., Tartara S., Cetrangolo A.A., Pensotti C., Pereyra B., Scapellato P.G., Stagnaro J.P., Shah S., Lotsch F., Thalhammer F., Anseeuw K., Francois C.A., Van Braeckel E., Vincent J.L., Djimon M.Z., Bashi J., Dodo R., Nouer S.A., Chipev P., Encheva M., Miteva D., Petkova D., Balkissou A.D., Yone E.W.P., Ngahane B.H.M., Shen N., Xu J.F., Rico C.A.B., Buitrago R., Paternina F.J.P., Ntumba J.K., Carevic V.V., Jakopovic M., Jankovic M., Matkovic Z., Mitrecic I., Jacobsson M.B., Christensen A.B., Bodtger U.C.H., Meyer C.N., Jensen A.V., Baunbaek-Knudsen G., Petersen P.T., Andersen S., El-Wahhab I.E.A., Morsy N.E., Shafiek H., Sobh E., Abdulsemed K.A., Bertrand F., Brun-Buisson C., de Montmollin E., Fartoukh M., Messika J., Tattevin P., Khoury A., Ebruke B., Dreher M., Kolditz M., Meisinger M., Niederlausitz K., Pletz M.W., Hagel S., Schaberg T., Spielmanns M., Creutz P., Suttorp N., Siaw-Lartey B., Dimakou K., Papapetrou D., Tsigou E., Ampazis D., Kaimakamis E., Bhatia M., Dhar R., D'Souza G., Garg R., Koul P.A., Mahesh P.A., Jayaraj B.S., Narayan K.V., Udnur H.B., Krishnamurthy S.B., Kant S., Swarnakar R., Limaye S., Salvi S., Golshani K., Keatings V.M., Martin-Loeches I., Maor Y., Strahilevitz J., Battaglia S., Carrabba M., Ceriana P., Confalonieri M., Monforte A.D., Prato B.D., Rosa M., Fantini R., Fiorentino G., Gammino M.A., Menzella F., Milani G., Nava S., Palmiero G., Petrino R., Gabrielli B., Rossi P., Sorino C., Steinhilber G., Zanforlin A., Franzetti F., Carugati M., Morosi M., Monge E., Carone M., Patella V., Scarlata S., Comel A., Kurahashi K., Bacha Z.A., Ugalde D.B., Zuniga O.C., Villegas J.F., Medenica M., van de Garde E.M.W., Mihsra D.R., Shrestha P., Ridgeon E., Awokola B.I., Nwankwo O.N.O., Olufunlola A.B., Olumide S., Ukwaja K.N., Irfan M., Minarowski L., Szymon S., Froes F., Leuschner P., Meireles M., Ferrao C., Neves J., Ravara S.B., Brocovschii V., Ion C., Rusu D., Toma C., Chirita D., Dorobat C.M., Birkun A., Kaluzhenina A., Almotairi A., Bukhary Z.A.A., Edathodu J., Fathy A., Enani A.M.A., Mohamed N.E., Memon J.U., Bella A., Bogdanovic N., Milenkovic B., Pesut D., Borderias L., Garcia N.M.B., Alarcon H.C., Cilloniz C., Torres A., Diaz-Brito V., Casas X., Gonzalez A.E., Fernandez-Almira ML., Gallego M., Gaspar-GarcIa I., Victoria P.J., Martinez E.L., de Molina R.M., Marcos P.J., Menendez R., Pando-Sandoval A., Aymerich C.P., de la Torre A.L., Garcia-Olive I., Rello J., Moyano S., Sanz F., Sibila O., Rodrigo-Troyano A., Sole-Violan J., Uranga A., van Boven J.F.M., Torra E.V., Pujol J.A., Feldman C., Yum H.K., Fiogbe A.A., Yangui F., Bilaceroglu S., Dalar L., Yilmaz U., Bogomolov A., Elahi N., Dhasmana D.J., Feneley A., Ions R., Skeemer J., Woltmann G., Hancock C., Hill A.T., Rudran B., Ruiz-Buitrago S., Campbell M., Whitaker P., Youzguin A., Singanayagam A., Allen K.S., Brito V., Dietz J., Dysart C.E., Kellie S.M., Franco-Sadud R.A., Meier G., Gaga M., Holland T.L., Bergin S.P., Kheir F., Landmeier M., Lois M., Nair G.B., Patel H., Reyes K., Rodriguez-Cintron W., Saito S., Soni N.J., Noda J., Hinojosa C.I., Levine S.M., Angel L.F., Anzueto A., Whitlow K.S., Hipskind J., Sukhija K., Totten V., Wunderink R.G., Shah R.D., Mateyo K.J., Noriega L., Alvarado E., Aman M., and Labra L.
Subjects: 0301 basic medicine, Male, Pediatrics, Etiology, Multidrug-resistant pathogen, MRSA, Pneumocystis pneumonia, Pneumònia adquirida a la comunitat, HOSPITALIZED-PATIENTS, 0302 clinical medicine, Community-acquired pneumonia, Risk Factors, Prevalence, Medicine, 030212 general & internal medicine, PNEUMOCYSTIS PNEUMONIA, Articles and Commentaries, Aged, 80 and over, Respiratory tract infections, Anemia, Aplastic, Middle Aged, 3. Good health, Community-Acquired Infections, Europe, Infectious Diseases, Immunocompromise, Microbiology, Multidrug-resistant pathogens, Pneumonia, Etiologia, Hematologic Neoplasms, Female, BLOOD-STREAM INFECTIONS, Lung Transplantation, Microbiology (medical), medicine.medical_specialty, Asia, Neutropenia, 030106 microbiology, RESPIRATORY-TRACT INFECTIONS, Settore MED/10 - Malattie Dell'Apparato Respiratorio, TRANSPLANT RECIPIENTS, DISEASES-SOCIETY, 03 medical and health sciences, Immunocompromised Host, Pneumonia, Bacterial, MANAGEMENT, Humans, pneumonia, BACTERIAL PNEUMONIA, Aged, Acquired Immunodeficiency Syndrome, business.industry, microbiology, Bacterial pneumonia, Australia, medicine.disease, multidrug-resistant pathogens, Mycoses, Bacteremia, Africa, RISK-FACTORS, immunocompromise, Americas, business
Abstract: Background The correct management of immunocompromised patients with pneumonia is debated. We evaluated the prevalence, risk factors, and characteristics of immunocompromised patients coming from the community with pneumonia. Methods We conducted a secondary analysis of an international, multicenter study enrolling adult patients coming from the community with pneumonia and hospitalized in 222 hospitals in 54 countries worldwide. Risk factors for immunocompromise included AIDS, aplastic anemia, asplenia, hematological cancer, chemotherapy, neutropenia, biological drug use, lung transplantation, chronic steroid use, and solid tumor. Results At least 1 risk factor for immunocompromise was recorded in 18% of the 3702 patients enrolled. The prevalences of risk factors significantly differed across continents and countries, with chronic steroid use (45%), hematological cancer (25%), and chemotherapy (22%) the most common. Among immunocompromised patients, community-acquired pneumonia (CAP) pathogens were the most frequently identified, and prevalences did not differ from those in immunocompetent patients. Risk factors for immunocompromise were independently associated with neither Pseudomonas aeruginosa nor non–community-acquired bacteria. Specific risk factors were independently associated with fungal infections (odds ratio for AIDS and hematological cancer, 15.10 and 4.65, respectively; both P = .001), mycobacterial infections (AIDS; P = .006), and viral infections other than influenza (hematological cancer, 5.49; P < .001). Conclusions Our findings could be considered by clinicians in prescribing empiric antibiotic therapy for CAP in immunocompromised patients. Patients with AIDS and hematological cancer admitted with CAP may have higher prevalences of fungi, mycobacteria, and noninfluenza viruses.
Published: 2019

234. Differing severities of acute exacerbations of idiopathic pulmonary fibrosis (IPF): insights from the INPULSIS® trials

Author: Matthias Trampisch, Harald Koegler, S Geier, Luca Richeldi, and Michael Kreuter
Subjects: Male, 0301 basic medicine, medicine.medical_specialty, Indoles, Exacerbation, Nintedanib, Vital Capacity, Tyrosine kinase inhibitor, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, Placebo, Severity of Illness Index, Placebo group, 03 medical and health sciences, Idiopathic pulmonary fibrosis, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, Humans, Medicine, Enzyme Inhibitors, Treatment outcome, Adverse effect, Aged, lcsh:RC705-779, Disease progression, business.industry, Research, Clinical course, lcsh:Diseases of the respiratory system, Middle Aged, medicine.disease, Idiopathic Pulmonary Fibrosis, Serious adverse events, 030104 developmental biology, 030228 respiratory system, chemistry, Acute Disease, Female, Disease Progression, Etiology, business
Abstract: Given the broad definition of an acute exacerbation of IPF, it is likely that acute exacerbations are heterogeneous in their aetiology, severity and clinical course. We used pooled data from the INPULSIS® trials of nintedanib versus placebo to investigate whether acute exacerbations reported as serious adverse events were associated with higher mortality than those reported as non-serious adverse events and to assess the effect of nintedanib on these types of events. Adverse events considered by an investigator to be an acute exacerbation were adjudicated as a confirmed acute exacerbation, suspected acute exacerbation, or not an acute exacerbation. Time to first investigator-reported acute exacerbation or confirmed/suspected acute exacerbation reported as a serious adverse event or non-serious adverse event over the 52-week treatment period was assessed post-hoc. Deaths were assessed based on data collected over the 52-week treatment period. Of 63 patients who had ≥1 investigator-reported acute exacerbation, 48 (76.2%) had a first acute exacerbation reported as a serious adverse event. Thirty-six (3.4%) patients had ≥1 confirmed/suspected acute exacerbation, of whom 31 had a first event reported as a serious adverse event. Investigator-reported acute exacerbations reported as serious adverse events occurred in 23 patients in the nintedanib group and 26 in the placebo group. Confirmed/suspected acute exacerbations reported as serious adverse events occurred in 10 and 21 patients in these groups, respectively. Nintedanib significantly reduced the risk of a first acute exacerbation reported as a serious adverse event (HR 0.57 [95% CI: 0.32, 0.99]; p = 0.0476) and the risk of a first confirmed/suspected acute exacerbation reported as a serious adverse event (HR 0.30 [95% CI: 0.14, 0.64]; p = 0.0019) versus placebo. A higher proportion of patients with investigator-reported acute exacerbations reported as serious adverse events died than patients with acute exacerbations reported as non-serious adverse events (61.2% versus 7.1%). Different severities of acute exacerbation of IPF may exist. Acute exacerbations reported as serious adverse events in the INPULSIS® trials were associated with high mortality. Nintedanib significantly reduced the risk of acute exacerbations reported as serious adverse events. ClinicalTrials.gov NCT01335464 and NCT01335477 .
Published: 2019

235. Effects of nintedanib in patients with idiopathic pulmonary fibrosis by GAP stage

Author: Joyce S. Lee, Venerino Poletti, Luca Richeldi, Susanne Stowasser, Martin Kolb, D Wachtlin, and Christopher J. Ryerson
Subjects: Pulmonary and Respiratory Medicine, medicine.medical_specialty, Vital capacity, lcsh:Medicine, nintedanib, idiopathic pulmonary fibrosis, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, Placebo, Interstitial Lung Disease, Gastroenterology, 03 medical and health sciences, Idiopathic pulmonary fibrosis, chemistry.chemical_compound, FEV1/FVC ratio, 0302 clinical medicine, Internal medicine, Post-hoc analysis, medicine, In patient, 030212 general & internal medicine, Stage (cooking), business.industry, lcsh:R, Original Articles, medicine.disease, 3. Good health, 030228 respiratory system, chemistry, Nintedanib, business
Abstract: We conducted a post hoc analysis to assess the potential impact of GAP (gender, age, physiology) stage on the treatment effect of nintedanib in patients with idiopathic pulmonary fibrosis. Outcomes were compared in patients at GAP stage I versus II/III at baseline in the INPULSIS® trials. At baseline, 500 patients were at GAP stage I (nintedanib 304, placebo 196), 489 were at GAP stage II (nintedanib 296, placebo 193) and 71 were at GAP stage III (nintedanib 38, placebo 33). In nintedanib-treated patients, the annual rate of decline in forced vital capacity (FVC) was similar in patients at GAP stage I and GAP stage II/III at baseline (−110.1 and −116.6 mL·year−1, respectively), and in both subgroups was lower than in placebo-treated patients (−218.5 and −227.6 mL·year−1, respectively) (treatment-by-time-by-subgroup interaction p=0.92). In the nintedanib group, the number of deaths was 43.8% of those predicted based on GAP stage (35 versus 79.9). In the placebo group, the number of deaths was 59.8% of those predicted based on GAP stage (33 versus 55.2). In conclusion, data from the INPULSIS® trials suggest that nintedanib has a similar beneficial effect on the rate of FVC decline in patients at GAP stage I versus II/III at baseline., Nintedanib provides a similar benefit versus placebo on the rate of decline in forced vital capacity in patients with idiopathic pulmonary fibrosis irrespective of GAP stage at baseline http://ow.ly/HfJ730nNkRT
Published: 2019

236. Lung function outcomes in the INPULSIS® trials of nintedanib in idiopathic pulmonary fibrosis

Author: Toby M. Maher, Wibke Stansen, Yoshikazu Inoue, Vincent Cottin, Kevin K. Brown, Athol U. Wells, Ganesh Raghu, Susanne Stowasser, Kevin R. Flaherty, Arata Azuma, Luca Richeldi, Rozsa Schlenker-Herceg, and John T. Huggins
Subjects: Pulmonary and Respiratory Medicine, Vital capacity, medicine.medical_specialty, Interstitial lung diseases, Protein-tyrosine kinases, Pulmonary gas exchange, Respiratory function tests, Respiratory System, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, Placebo, 1102 Cardiovascular Medicine And Haematology, 03 medical and health sciences, FEV1/FVC ratio, Idiopathic pulmonary fibrosis, chemistry.chemical_compound, 0302 clinical medicine, DLCO, Internal medicine, Diffusing capacity, medicine, 030212 general & internal medicine, Oxygen saturation (medicine), business.industry, 1103 Clinical Sciences, respiratory system, medicine.disease, 030228 respiratory system, chemistry, Cardiology, Nintedanib, business
Abstract: Background In the INPULSIS® trials, nintedanib reduced the annual rate of decline in forced vital capacity (FVC) versus placebo, consistent with slowing of disease progression. We characterised the effects of nintedanib on physiologic outcomes using pooled data from the INPULSIS® trials. Methods Post-hoc analyses included changes in FVC over time, cumulative distribution of patients by change in FVC % predicted, and annual rate of decline in FVC in subgroups by diffusing capacity of the lung for carbon monoxide (DLco) and composite physiologic index (CPI) at baseline. Changes from baseline in DLco and oxygen saturation by pulse oximetry (SpO2) were pre-specified. Results Nintedanib significantly reduced FVC decline versus placebo from week 12. A higher proportion of patients treated with nintedanib than placebo had an improvement or no decline in FVC % predicted, whereas a smaller proportion had absolute declines in FVC ≥5% or ≥10% predicted from baseline to week 52. The effect of nintedanib on FVC decline was similar in patients with baseline DLco >40% versus ≤40% predicted or CPI ≤45 versus >45. There were no significant differences between nintedanib and placebo in change from baseline in DLco % predicted, CPI, or SpO2 at week 52. However, change (deterioration) in CPI was significantly lower with nintedanib versus placebo in patients with CPI > 45 at baseline (1.0 versus 2.9) and CPI >55 at baseline (−1.2 versus 3.3). Conclusions A range of physiologic outcome measures in the INPULSIS® trials support the effect of nintedanib on reducing disease progression in patients with IPF.
Published: 2019

237. Computed Tomographic Biomarkers in Idiopathic Pulmonary Fibrosis. The Future of Quantitative Analysis

Author: Jonathan G. Goldin, Ganesh Raghu, Stephen M. Humphries, Simon L.F. Walsh, Brian J. Bartholmai, Craig S Conoscenti, Joseph Jacob, James F. Gruden, Jan De Backer, Fernando J. Martinez, David Barber, Toby M. Maher, Kevin R. Flaherty, Luca Richeldi, Nicola Sverzellati, David A. Lynch, Athol U. Wells, Grace Kim, Eric A. Hoffman, Xiaoping Wu, Brian D. Ross, Margaret L. Salisbury, Rozsa Schlenker-Herceg, and Kevin K. Brown
Subjects: Pulmonary and Respiratory Medicine, medicine.medical_specialty, Vital capacity, AUTOMATED QUANTIFICATION, Respiratory System, TREATMENT TRIALS, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, INTERSTITIAL LUNG-DISEASE, Critical Care and Intensive Care Medicine, Idiopathic pulmonary fibrosis, Critical Care Medicine, General & Internal Medicine, END-POINTS, medicine, Humans, Quantitative computed tomography, Intensive care medicine, Tomography, Lung, 11 Medical and Health Sciences, Pulmonologists, Science & Technology, medicine.diagnostic_test, Surrogate endpoint, business.industry, Interstitial lung disease, STAGING SYSTEM, medicine.disease, Idiopathic Pulmonary Fibrosis, X-Ray Computed, Clinical trial, HIGH-RESOLUTION CT, quantitative computed tomography, IMAGING BIOMARKERS, biomarker, Biomarker (medicine), Tomography, X-Ray Computed, business, Life Sciences & Biomedicine, FORCED VITAL CAPACITY, HYPERSENSITIVITY PNEUMONITIS, CLINICAL-TRIALS, Biomarkers, Forecasting
Abstract: Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease with great variability in disease severity and rate of progression. The need for a reliable, sensitive, and objective biomarker to track disease progression and response to therapy remains a great challenge in IPF clinical trials. Over the past decade, quantitative computed tomography (QCT) has emerged as an area of intensive research to address this need. We have gathered a group of pulmonologists, radiologists and scientists with expertise in this area to define the current status and future promise of this imaging technique in the evaluation and management of IPF. In this Pulmonary Perspective, we review the development and validation of six computer-based QCT methods and offer insight into the optimal use of an imaging-based biomarker as a tool for prognostication, prediction of response to therapy, and potential surrogate endpoint in future therapeutic trials.
Published: 2019

238. EAACI Guidelines on Allergen Immunotherapy: House dust mite-driven allergic asthma

Author: Elisabeth Angier, Pawe Gajdanowicz, Ozlem Cavkaytar, Milena Sokolowska, Ralph Mösges, Cezmi A. Akdis, Marek Jutel, Oscar Palomares, Dermot Ryan, Matteo Bonini, Ioana Agache, Juan José Yepes-Nuñez, Graham Roberts, Oliver Pfaar, Nikolaos G. Papadopoulos, Omer Kalayci, Breda Flood, Giovanni Battista Pajno, Ronald van Ree, Gunter J. Sturm, Kenji Izuhara, Roy Gerth van Wijk, Eva M. Varga, Montserrat Fernandez-Rivas, Susanne Lau, Sylwia Smolinska, Erasmus MC other, Internal Medicine, Ear, Nose and Throat, Experimental Immunology, AII - Inflammatory diseases, APH - Global Health, and APH - Personalized Medicine
Subjects: 0301 basic medicine, Pediatrics, medicine.medical_specialty, Allergen immunotherapy, Allergy, Lydia Becker Institute, medicine.medical_treatment, Immunology, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, medicine.disease_cause, 03 medical and health sciences, 0302 clinical medicine, Allergen, Pharmacotherapy, ResearchInstitutes_Networks_Beacons/lydia_becker_institute_of_immunology_and_inflammation, allergen immunotherapy, allergy, asthma, asthma control, asthma exacerbations, GRADE, house dust mites, lung function, medicine, Animals, Humans, Immunology and Allergy, Antigens, Dermatophagoides, Asthma, Desensitization (medicine), House dust mite, biology, business.industry, Pyroglyphidae, lung function, Guideline, Allergens, asthma, allergy, medicine.disease, biology.organism_classification, asthma control, respiratory tract diseases, GRADE, 030104 developmental biology, 030228 respiratory system, Desensitization, Immunologic, asthma exacerbations, allergen immunotherapy, business, house dust mites
Abstract: Allergen immunotherapy (AIT) has been in use for the treatment of allergic disease for more than 100 years. Asthma treatment relies mainly on corticosteroids and other controllers recommended to achieve and maintain asthma control, prevent exacerbations, and improve quality of life. AIT is underused in asthma, both in children and in adults. Notably, patients with allergic asthma not adequately controlled on pharmacotherapy (including biologics) represent an unmet health need. The European Academy of Allergy and Clinical Immunology has developed a clinical practice guideline providing evidence-based recommendations for the use of house dust mites (HDM) AIT as add-on treatment for HDM-driven allergic asthma. This guideline was developed by a multi-disciplinary working group using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. HDM AIT was separately evaluated by route of administration and children and adults: subcutaneous (SCIT) and sublingual AIT (SLIT), drops, and tablets. Recommendations were formulated for each. The important prerequisites for successful treatment with HDM AIT are (a) selection of patients most likely to respond to AIT and (b) use of allergen extracts and desensitization protocols of proven efficacy. To date, only AIT with HDM SLIT-tablet has demonstrated a robust effect in adults for critical end points (exacerbations, asthma control, and safety). Thus, it is recommended as an add-on to regular asthma therapy for adults with controlled or partially controlled HDM-driven allergic asthma (conditional recommendation, moderate-quality evidence). HDM SCIT is recommended for adults and children, and SLIT drops are recommended for children with controlled HDM-driven allergic asthma as the add-on to regular asthma therapy to decrease symptoms and medication needs (conditional recommendation, low-quality evidence).
Published: 2019

239. Epidemiology, Physiology and Clinical Approach to Sleepiness at the Wheel in OSA Patients: A Narrative Review

Author: Maria R. Bonsignore, Carolina Lombardi, Simone Lombardo, Francesco Fanfulla, Bonsignore, Maria R, Lombardi, Carolina, Lombardo, Simone, and Fanfulla, Francesco
Subjects: motor vehicle accidents, General Medicine, driving license, Settore MED/10 - Malattie Dell'Apparato Respiratorio, Epworth Sleepiness Scale, commercial driver, maintenance of wakefulness test
Abstract: Sleepiness at the wheel (SW) is recognized as an important factor contributing to road traffic accidents, since up to 30 percent of fatal accidents have been attributed to SW. Sleepiness-related motor vehicle accidents may occur both from falling asleep while driving and from behavior impairment attributable to sleepiness. SW can be caused by various sleep disorders but also by behavioral factors such as sleep deprivation, shift work and non-restorative sleep, as well as chronic disease or the treatment with drugs that negatively affect the level of vigilance. An association between obstructive sleep apnea (OSA) and motor vehicle accidents has been found, with an increasing risk in OSA patients up to sevenfold in comparison to the general population. Regular treatment with continuous positive airway pressure (CPAP) relieves excessive daytime sleepiness and reduces the crash risk. Open questions still remain about the physiological and clinical determinants of SW in OSA patients: the severity of OSA in terms of the frequency of respiratory events (apnea hypopnea index, AHI) or hypoxic load, the severity of daytime sleepiness, concomitant chronic sleep deprivation, comorbidities, the presence of depressive symptoms or chronic fatigue. Herein, we provide a review addressing the epidemiological, physiological and clinical aspects of SW, with a particular focus on the methods to recognize those patients at risk of SW.
Published: 2022

240. When kidneys and lungs suffer together

Author: Stefano Negri, Claudio Pedone, Antonio Spanevello, Nicola Scichilone, Claudio Sorino, Dina Visca, Sorino, Claudio, Scichilone, Nicola, Pedone, Claudio, Negri, Stefano, Visca, Dina, and Spanevello, Antonio
Subjects: Lung Diseases, Nephrology, medicine.medical_specialty, 030232 urology & nephrology, Renal function, Settore MED/10 - Malattie Dell'Apparato Respiratorio, 030204 cardiovascular system & hematology, Lung injury, Pulmonary Disease, Chronic Obstructive, 03 medical and health sciences, Mechanical ventilation, 0302 clinical medicine, Renal Dialysis, Internal medicine, Acute lung injury, COPD, Pulmonary-renal syndrome, Acute kidney injury, Humans, Medicine, business.industry, medicine.disease, respiratory tract diseases, Pneumonia, Albuminuria, Cardiology, Kidney Failure, Chronic, Kidney Diseases, medicine.symptom, Renal compensation, business, Kidney disease
Abstract: A significant interaction between kidneys and lungs has been shown in physiological and pathological conditions. The two organs can both be targets of the same systemic disease (eg., some vasculitides). Moreover, loss of normal function of either of them can induce direct and indirect dysregulation of the other one. Subjects suffering from COPD may have systemic inflammation, hypoxemia, endothelial dysfunction, increased sympathetic activation and increased aortic stiffness. As well as the exposure to nicotine, all the foresaid factors can induce a microvascular damage, albuminuria, and a worsening of renal function. Renal failure in COPD can be unrecognized since elderly and frail patients may have normal serum creatinine concentration. Lungs and kidneys participate in maintaining the acid-base balance. Compensatory role of the lungs rapidly expresses through an increase or reduction of ventilation. Renal compensation usually requires a few days as it is achieved through changes in bicarbonate reabsorption. Chronic kidney disease and end-stage renal diseases increase the risk of pneumonia. Vaccination against Streptococcus pneumonia and seasonal influenza is recommended for these patients. Vaccines against the last very virulent H1N1 influenza A strain are also available and effective. Acute lung injury and acute kidney injury are frequent complications in critical illnesses, associated with high morbidity and mortality. The concomitant failure of kidneys and lungs implies a multidisciplinary approach, both in terms of diagnostic processes and therapeutic management.
Published: 2018

241. Is kidney a new organ target in patients with obstructive sleep apnea? Research priorities in a rapidly evolving field

Author: Maria R. Bonsignore, Athanasios Voulgaris, Sophia E. Schiza, Oreste Marrone, Paschalis Steiropoulos, Voulgaris A., Bonsignore M.R., Schiza S., Marrone O., and Steiropoulos P.
Subjects: medicine.medical_specialty, Polysomnography, Renal function, Disease, Positive airway pressure, Settore MED/10 - Malattie Dell'Apparato Respiratorio, urologic and male genital diseases, Kidney, End stage renal disease, End-stage renal disease, Chronic kidney disease, Epidemiology, medicine, Humans, Sleep-disordered breathing, Intensive care medicine, Sleep Apnea, Obstructive, business.industry, Research, General Medicine, medicine.disease, Obstructive sleep apnea, female genital diseases and pregnancy complications, respiratory tract diseases, Natural history, Kidney Failure, Chronic, business, Kidney disease
Abstract: The bidirectional relationship between sleep disordered breathing and chronic kidney disease (CKD) has recently gained a lot of interest. Several lines of evidence suggest the high prevalence of coexistent obstructive sleep apnea (OSA) in patients with CKD and end-stage renal disease (ESRD). In addition, OSA seems to result in loss of kidney function in some patients, especially in those with cardio-metabolic comorbidities. Treatment of CKD/ESRD and OSA can alter the natural history of each other; still better phenotyping with selection of appropriate treatment approaches is urgently needed. The aim of this narrative review is to provide an update of recent studies on epidemiological associations, pathophysiological interactions, and management of patients with OSA and CKD or ESRD.
Published: 2021

242. Diagnostic Insights from Plethysmographic Alveolar Pressure Assessed during Spontaneous Breathing in COPD Patients

Author: Zilianti, C., Santus, P., Pecchiari, M., D'Angelo, E., and Radovanovic, D.
Subjects: plethysmographic loops, expiratory flow-limitation, Medicine (General), R5-920, PEEPi, chronic obstructive pulmonary disease, respiratory function tests, Settore MED/10 - Malattie dell'Apparato Respiratorio, Review, respiratory system, Settore BIO/09 - Fisiologia
Abstract: Since its introduction in the clinical practice, body plethysmography has assisted pneumologists in the diagnosis of respiratory diseases and patients' follow-up, by providing easy assessment of absolute lung volumes and airway resistance. In the last decade, emerging evidence suggested that estimation of alveolar pressure by electronically-compensated plethysmographs may contain information concerning the mechanics of the respiratory system which goes beyond those provided by the simple value of airway resistance or conductance. Indeed, the systematic study of expiratory alveolar pressure-flow loops produced during spontaneous breathing at rest has shown that the marked expansion of expiratory loops in chronic obstructive pulmonary disease patients mainly reflects the presence of tidal expiratory flow-limitation. The presence of this phenomenon can be accurately predicted on the basis of loop-derived parameters. Finally, we present results suggesting that plethysmographic alveolar pressure may be used to estimate non-invasively intrinsic positive end-expiratory pressure (PEEPi) in spontaneously breathing patients, a task which previously could be only accomplished by introducing a balloon-tipped catheter in the esophagus.
Published: 2021

243. The bizarre appearance of intrathoracic extramedullary hematopoiesis during an endoscopic ultrasound examination

Author: Vanina Livi, Daniela Paioli, Alessandra Cancellieri, Alberto Larghi, and Rocco Trisolini
Subjects: Endoscopic ultrasound, medicine.medical_specialty, medicine.diagnostic_test, endoscopic ultrasound examination, business.industry, Gastroenterology, Bizarre appearance, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, medicine.disease, Mediastinal Neoplasms, Extramedullary hematopoiesis, Endosonography, Hematopoiesis, Extramedullary, medicine, Humans, Radiology, business, Ultrasonography
Published: 2021

244. One-Year Evolution of Symptoms and Health Status of the COPD Multi-Dimensional Phenotypes: Results from the Follow-Up of the STORICO Observational Study

Author: Nicola Scichilone, Alessandro Zullo, Lucia Simoni, Raffaele Antonelli Incalzi, Giorgio Walter Canonica, Francesco Blasi, Incalzi R.A., Blasi F., Scichilone N., Zullo A., Simoni L., and Canonica G.W.
Subjects: medicine.medical_specialty, phenotype, Quality of sleep, Health Status, quality of sleep, Settore MED/10 - Malattie Dell'Apparato Respiratorio, International Journal of Chronic Obstructive Pulmonary Disease, Disease cluster, 03 medical and health sciences, Diseases of the respiratory system, Pulmonary Disease, Chronic Obstructive, 0302 clinical medicine, Quality of life, Internal medicine, Surveys and Questionnaires, evolution, medicine, cohort study, Humans, In patient, 030212 general & internal medicine, Original Research, COPD, RC705-779, business.industry, real world, Cohort study, Evolution, Phenotype, Quality of life, Quality of sleep, Real world, General Medicine, medicine.disease, 030228 respiratory system, quality of life, Multi dimensional, Observational study, business, Cohort study, Follow-Up Studies
Abstract: Raffaele Antonelli Incalzi,1 Francesco Blasi,2,3 Nicola Scichilone,4 Alessandro Zullo,5 Lucia Simoni,5 Giorgio Walter Canonica6 On Behalf of STORICO study group1Internal Medicine and Geriatrics Department Biomedical Campus University of Rome, Rome, Italy; 2Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Adult Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy; 3Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy; 4DIBIMIS, University of Palermo, Palermo, Italy; 5Medineos Observational Research, Modena, Italy; 6Personalized Medicine Asthma & Allergy Clinic, Humanitas University, Humanitas & Research Hospital-IRCCS, Rozzano (Milan), ItalyCorrespondence: Raffaele Antonelli IncalziBiomedical Campus, University of Rome, Via Alvaro Del Portillo, 21, Rome, 00128, ItalyTel +39 06 22541 1365Fax +39 06 22541 456Email papermultiSTORICO@medineos.comAim: Describing the 1-year evolution of symptoms and health status in COPD patients enrolled in the STORICO study (observational study on characterization of 24-h symptoms in patients with COPD) classified in multidimensional phenotypes (m-phenotypes).Methods: In our previous study, we performed an exploratory factor analysis to identify clinical and pathophysiological variables having the greatest classificatory properties, followed by a cluster analysis to group patients into m-phenotypes (mild COPD (MC), mild emphysematous (ME), severe bronchitic (SB), severe emphysematous (SE), and severe mixed COPD (SMC)). COPD symptoms were recorded at baseline, 6-, and 12-month follow-up and their evolution was described as frequency of patients with always present, always absent, arising’, ‘no more present symptoms. QoL and quality of sleep were evaluated using the SGRQ and CASIS questionnaires, respectively.Results: We analyzed 379 subjects (144 MC, 71 ME, 96 SB, 14 SE, 54 SMC). M-phenotypes were stable over time in terms of presence of symptoms and health status with selected differences in evolution of symptoms in mild vs severe m-phenotypes. Indeed, 28.1% SB, 50.0% SE and 24.1% SMC vs 0.7% MC and 5.6% ME with night-time symptoms at baseline had no more symptoms at 6-month (p-value night-time symptom evolution MC vs SB, SE, SMC and ME vs SB, SE, SMC < 0.0001). All m-phenotypes improved in quality of sleep, more markedly the severe than the mild ones (p-values CASIS score change between baseline and 6- or 12-month in MC, ME vs SB, SE, SMC < 0.0001). QoL did not change during observation, irrespectively of m-phenotype.Conclusion: Over 1 year, severe m-phenotypes showed an improvement in night-time symptoms and quality of sleep, but not QoL. Being stable over time, m-phenotypes seem worthy of testing for classificatory and prognostic purposes.Keywords: phenotype, evolution, quality of sleep, quality of life, real world, cohort study
Published: 2021

245. The value of cytology in distinguishing malignant mesothelioma: An institutional experience of 210 cases reclassified according to the International System for Reporting Serous Fluid Cytopathology (ISRSFC)

Author: Rocco Trisolini, Patrizia Straccia, Alessandra Cancellieri, Marco Chiappetta, Daniele Magnini, and Filippo Lococo
Subjects: Mesothelioma, Pathology, medicine.medical_specialty, Histology, Cytodiagnosis, Cytological Techniques, 030209 endocrinology & metabolism, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, Malignancy, Pathology and Forensic Medicine, ISRSFC, 03 medical and health sciences, cytology effusions, 0302 clinical medicine, Cytology, Atypia, medicine, Humans, Stage (cooking), Retrospective Studies, Suspicious for Malignancy, International System for Reporting Serous Fluid Cytopathology, business.industry, Mesothelioma, Malignant, General Medicine, medicine.disease, Serous fluid, Cytopathology, 030220 oncology & carcinogenesis, business
Abstract: Objective Malignant mesothelioma (MM) is usually diagnosed by histological examination of tissue samples; however, effusion cytology offers an opportunity to identify a strong possibility for mesothelioma diagnosis at an early stage. We conducted a retrospective analysis of cytological specimens from a large series of histologically proven MM diagnosed over 19 years. The cases were reviewed and reclassified according to the International System for Reporting Serous Fluid Cytopathology (ISRSFC). Methods A total of 450 cases were identified. Cytological analysis was present in 210 patients (164 pleural and 46 peritoneal effusions). All cases were reviewed and reclassified according to the proposed ISRSFC scheme. A comparison among the cytomorphological features was made throughout the different diagnostic categories. Results The 210 cases were histologically diagnosed as follows: 192 (91.4%) cases had an epithelioid type and 18 (8.6%) had a sarcomatoid subtype of MM. The cytological cases were reclassified as follows: 2 (0.9%) as non-diagnostic (ND), 81 (38.6%) as negative for malignancy (NFM), 4 (1.9%) as atypia of undetermined significance (AUS), 11 (5.2%) as suspicious for malignancy (SFM), 112 (53.4%) as malignant (MAL). Sarcomatoid cells in the MAL category were characterised cytomorphologically by more pronounced discohesion. In comparison with the epithelioid subtype, the tumour cells appeared solitary with moderate or marked nuclear pleomorphism, and irregular chromatin. Conclusions It is important to recognise the cytological characteristics of this aggressive entity to suggest an early and precise possible diagnosis. Morphological features, coupled with clinico-radiological data may help the clinicians in adequately managing the patients.
Published: 2021

246. Impact of temperature on obstructive sleep apnoea in three different climate zones of Europe: Data from the European Sleep Apnoea Database (ESADA)

Author: Renata L. Riha, Richard Staats, Sébastien Bailly, Athanasia Pataka, Maria R. Bonsignore, Carolina Lombardi, Jan Hedner, Johan Verbraecken, Ozen K. Basoglu, Ondrej Ludka, Ludger Grote, Silke Ryan, Sophia E. Schiza, Tarja Saaresranta, Repositório da Universidade de Lisboa, European Sleep Apnoea Database ESA, Staats R., Bailly S., Bonsignore M.R., Ryan S., Riha R.L., Schiza S., Verbraecken J., Basoglu O.K., Saaresranta T., Pataka A., Ludka O., Lombardi C., Hedner J.A., and Grote L.
Subjects: Cognitive Neuroscience, Settore MED/10 - Malattie Dell'Apparato Respiratorio, Environment, computer.software_genre, Body Mass Index, Cohort Studies, 03 medical and health sciences, Behavioral Neuroscience, Sleep Apnea Syndrome, Sleep Apnea Syndromes, 0302 clinical medicine, Environmental temperature, stomatognathic system, Humans, Medicine, Oxygen saturation (medicine), Climate zones, Sleep Apnea, Obstructive, Oxygen desaturation, Database, business.industry, Temperature, General Medicine, Sleep in non-human animals, Sleep-related breathing disorders, nervous system diseases, respiratory tract diseases, Clinical neurology, sleep&#8208, 030228 respiratory system, Climate zone, related breathing disorders, sleep-related breathing disorder, Human medicine, Cohort Studie, business, Body mass index, computer, 030217 neurology & neurosurgery, Human
Abstract: Recent studies indicate that ambient temperature may modulate obstructive sleep apnoea (OSA) severity. However, study results are contradictory warranting more investigation in this field. We analysed 19,293 patients of the European Sleep Apnoea Database (ESADA) cohort with restriction to the three predominant climate zones according to the Koppen-Geiger climate classification: Cfb (warm temperature, fully humid, warm summer), Csa (warm temperature, summer dry, hot summer), and Dfb (snow, fully humid, warm summer). Average outside temperature values were obtained and several hierarchical regression analyses were performed to investigate the impact of temperature on the apnea-hypopnea index (AHI), oxygen desaturation index (ODI), time of oxygen saturation, Fundacao para a Ciencia e a Tecnologia (FCT), Portugal; European Union; ResMed Foundation; Philips Respironics Foundation; European Respiratory Society (ERS), RS received financial support by the Fundacao para a Ciencia e a Tecnologia (FCT), Portugal. We would like to thank the members of the Pneumology Department of the University Hospital Lisbon, in particular to Andreia Colaco (RN), Claudia Pereira (RN), Dina Fernandes (RN), and Cristina Barbara (MD, Professor) for their support. The ESADA network was founded during the COST action B26 supported by the European Union and is one of the Clinical Research Collaborations (CRC) funded by the European Respiratory Society (ERS). Unrestricted seeding grants from the ResMed Foundation and the Philips Respironics Foundation for establishment of the database in 2007 and 2011 are gratefully acknowledged. Non--financial support was provided by the European Sleep Research Society (ESRS) and the European Respiratory Society (ERS) in terms of logistics for communication, meetings, and data presentations for the ESADA collaborators.
Published: 2021

247. To stent or not to stent? Treating angina after ISCHEMIA-introduction

Author: William E. Boden, Thomas F. Lüscher, Bernard J. Gersh, Deepak L. Bhatt, Peter Stone, and Filippo Crea
Subjects: medicine.medical_specialty, business.industry, medicine.medical_treatment, Ischemia, MEDLINE, Stent, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, medicine.disease, Revascularization, Coronary Angiography, Surgery, Angina Pectoris, angina, Angina, Osteopathic manipulation, Text mining, Medicine, Humans, Stents, Cardiology and Cardiovascular Medicine, business
Published: 2021

248. Large Cell Neuro-Endocrine Carcinoma of the Lung: Current Treatment Options and Potential Future Opportunities

Author: Miriam Grazia Ferrara, Alessio Stefani, Michele Simbolo, Sara Pilotto, Maurizio Martini, Filippo Lococo, Emanuele Vita, Marco Chiappetta, Alessandra Cancellieri, Ettore D’Argento, Rocco Trisolini, Guido Rindi, Aldo Scarpa, Stefano Margaritora, Michele Milella, Giampaolo Tortora, and Emilio Bria
Subjects: 0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, medicine.medical_treatment, neuro-endocrine, Disease, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, Review, Neuroendocrine tumors, lcsh:RC254-282, Targeted therapy, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Carcinoma, Medicine, Lung cancer, treatment, business.industry, Large cell, Standard treatment, large cell, medicine.disease, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Regimen, lung cancer, 030104 developmental biology, 030220 oncology & carcinogenesis, review, business
Abstract: Large-cell neuroendocrine carcinomas of the lung (LCNECs) are rare tumors representing 1–3% of all primary lung cancers. Patients with LCNEC are predominantly male, older, and heavy smokers. Histologically, these tumors are characterized by large cells with abundant cytoplasm, high mitotic rate, and neuroendocrine immunohistochemistry-detected markers (chromogranin-A, synaptophysin, and CD56). In 2015 the World Health Organization classified LCNEC as a distinct subtype of pulmonary large-cell carcinoma and, therefore, as a subtype of non-small cell lung carcinoma (NSCLC). Because of the small-sized tissue samples and the likeness to other neuroendocrine tumors, the histological diagnosis of LCNEC remains difficult. Clinically, the prognosis of metastatic LCNECs is poor, with high rates of recurrence after surgery alone and overall survival of approximately 35% at 5 years, even for patients with early stage disease that is dramatically shorter compared with other NSCLC subtypes. First-line treatment options have been largely discussed but with limited data based on phase II studies with small sample sizes, and there are no second-line well defined treatments. To date, no standard treatment regimen has been developed, and how to treat LCNEC is still on debate. In the immunotherapy and targeted therapy era, in which NSCLC treatment strategies have been radically reshaped, a few data are available regarding these opportunities in LCNEC. Due to lack of knowledge in this field, many efforts have been done for a deeper understanding of the biological and molecular characteristics of LCNEC. Next generation sequencing analyses have identified subtypes of LCNEC that may be relevant for prognosis and response to therapy, but further studies are needed to better define the clinical impact of these results. Moreover, scarce data exist about PD-L1 expression in LCNEC and its predictive value in this histotype with regard to immunotherapy efficacy. In the literature some cases are reported concerning LCNEC metastatic patients carrying driver mutations, especially EGFR alterations, showing targeted therapy efficacy in this setting of disease. Due to the rarity and the challenging understanding of LCNEC, in this review we aim to summarize the management options currently available for treatment of LCNEC.
Published: 2021

249. Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe eosinophilic asthma treated with benralizumab (ANDHI): a randomised, controlled, phase 3b trial

Author: Harrison, Tim W, Chanez, Pascal, Menzella, Francesco, Canonica, Giorgio Walter, Louis, Renaud, Cosio, Borja G, Lugogo, Njira L, Mohan, Arjun, Burden, Annie, McDermott, Lawrence, Garcia Gil, Esther, Zangrilli, James G, Wolfgang Pohl, Robert Voves, Maud Deschampheleire, Renaud Louis, Jean-Benoit Martinot, Rudi Peché, Kenneth Chapman, Amarjit Cheema, Delbert Dorscheid, J Mark FitzGerald, Remi Gagnon, William Patrick Killorn, Ronald Olivenstein, George Philteos, Clare Ramsey, J Douglass Rolf, Brandie Walker, Ole Hilberg, Tina Skjold, Ingrid Titlestad, Auli Hakulinen, Maritta Kilpeläinen, Michèle Ben Hayoun, Philippe Bonniaud, Arnaud Bourdin, Pascal Chanez, Frédéric De Blay, Gaëtan Deslee, Gilles Devouassoux, Alain Didier, Youcef Douadi, Stéphanie Fry, Gilles Garcia, Pierre-Olivier Girodet, Christophe Leroyer, Antoine Magnan, Guillaume Mahay, Cécilia Nocent, Christophe Pison, Pauline-Marie Roux, Camille Taillé, Juliana-Angelica Tiotiu, Ekkehard Beck, Margret Jandl, Christian Kaehler, Frank Kässner, Frank Koesters, Juliane Kronsbein, Thomas Schaum, Christian Schulz, Dirk Skowasch, Christian Taube, Tobias Welte, Andrés de Roux, Bianca Beghé, Francesco Blasi, Giorgio Walter Canonica, Giovanna Carpagnano, Cristiano Caruso, Angelo Guido Corsico, Elio Constantino, Nunzio Crimi, Piero Maestrelli, Francesco Menzella, Manlio Milanese, Alberto Papi, Girolamo Pelaia, Laura Pini, Pierachille Santus, Eleonora Savi, Nicola Scichilone, Gianenrico Senna, Giuseppe Spadaro, Adriano Vaghi, Steven Gans, Jurgen Hölters, B Langeveld, Willem Pieters, G H A Staaks, Ilonka van Veen, J W K van den Berg, Gunnar Einvik, Sverre Lehmann, Ismael Ali García, Carlos Almonacid, Irina Bobolea, Paloma Campo Mozo, Gustavo de Luiz, Christian Domingo Ribas, José María Echave-Sustaeta María-Tomé, Juan Luis García Rivero, Borja García-Cosío Piqueras, Ana Gómez-Bastero Fernández, Ruperto González Pérez, Aythamy Henríquez Santa, Carlos Martínez Rivera, Xavier Muñoz Gall, Jacinto Ramos, Jose Gregorio Soto Campos, Carmen Vidal Pan, Nikolai Stenfors, Alf Tunsäter, Ines Vinge, Rekha Chaudhuri, Timothy Harrison, Adel Mansur, Shuaib Nasser, Monica Nordstrom, Paul Pfeffer, Dinesh Saralaya, Philip Short, Arun Adlakha, Oral Alpan, Francis Averill, Anil Badhwar, Jose Bardelas, Barbara Baxter, George Bensch, William Berger, Jonathan Bernstein, Tracy Bridges, Ryan Brimeyer, William Calhoun, Edward Campbell, William Brett Cherry, Geoffrey Chupp, Lee Clore, John Cohn, Jeremy Cole, John Condemi, James Cury, Benjamin Davis, Samuel DeLeon, Luis Delacruz, Joseph Diaz, David Erb, Emeka Eziri, Faisal Fakih, Douglas Fiedler, David Fost, Stephen Fritz, Erika Gonzalez, Brad Goodman, Peter Gottlieb, Gregory Gottschlich, Richard Gower, Rizan Hajal, James Harris, Hengameh Heidarian-Raissy, Albrecht Heyder, David Hill, Fernando Holguin, Iftikhar Hussain, Jonathan Illowite, Joshua Jacobs, Mikell Jarratt, Harold Kaiser, Neil Kao, Ravindra Kashyap, David Kaufman, Edward Kent, Kenneth Kim, Ryan Klein, Monica Kraft, Ritsu Kono, Shahrukh Kureishy, Jeffrey Leflein, Mila Leong, Huamin Li, Robert Lin, Njira Lugogo, Michael Marcus, Diego Jose Maselli Caceres, Vinay Mehta, Curtis Mello, Mark Millard, Aaron Milstone, Arjun Mohan, Wendy Moore, Mark Moss, Nayla Mumneh, Thomas O'Brien, David Ostransky, Michael Palumbo, Purvi Parikh, Sudhir Parikh, Amit Patel, Guido Perez, Warren Pleskow, Bruce Prenner, Dileep Puppala, John Ramey, Joan Reibman, Ramon Reyes, Emory Robinette, Ileana Rodicio, Stephen Ryan, Sudhir Sekhsaria, Barry Sigal, Vinay Sikand, Weily Soong, Selwyn Spangenthal, Roy St John, Gary Steven, Vijay Subramaniam, Kaharu Sumino, Eric Sztejman, Ricardo A Tan, Tonny Tanus, Charles Thompson, Carl Thornblade, Manuel Villareal, Sally Wenzel, Heidi Zafra, Tomasz Ziedalski, Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Pathologies Pulmonaires et Plasticité Cellulaire - UMR-S 1250 (P3CELL), Université de Reims Champagne-Ardenne (URCA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Tim W, Harrison, Pascal, Chanez, Francesco, Menzella, Giorgio Walter, Canonica, Renaud, Loui, Borja G, Cosio, Njira L, Lugogo, Arjun, Mohan, Annie, Burden, Lawrence, Mcdermott, Esther, Garcia Gil, Zangrilli, G, Jame, Pohl, Wolfgang, Voves, Robert, Deschampheleire, Maud, Louis, Renaud, Martinot, Jean-Benoit, Peché, Rudi, Chapman, Kenneth, Cheema, Amarjit, Dorscheid, Delbert, Mark FitzGerald, J, Gagnon, Remi, Patrick Killorn, William, Olivenstein, Ronald, Philteos, George, Ramsey, Clare, Douglass Rolf, J, Walker, Brandie, Hilberg, Ole, Skjold, Tina, Titlestad, Ingrid, Hakulinen, Auli, Kilpeläinen, Maritta, Ben Hayoun, Michèle, Bonniaud, Philippe, Bourdin, Arnaud, Chanez, Pascal, De Blay, Frédéric, Deslee, Gaëtan, Devouassoux, Gille, Didier, Alain, Douadi, Youcef, Fry, Stéphanie, Garcia, Gille, Girodet, Pierre-Olivier, Leroyer, Christophe, Magnan, Antoine, Mahay, Guillaume, Nocent, Cécilia, Pison, Christophe, Roux, Pauline-Marie, Taillé, Camille, Tiotiu, Juliana-Angelica, Beck, Ekkehard, Jandl, Margret, Kaehler, Christian, Kässner, Frank, Koesters, Frank, Kronsbein, Juliane, Schaum, Thoma, Schulz, Christian, Skowasch, Dirk, Taube, Christian, Welte, Tobia, de Roux, André, Beghé, Bianca, Blasi, Francesco, Walter Canonica, Giorgio, Carpagnano, Giovanna, Caruso, Cristiano, Guido Corsico, Angelo, Constantino, Elio, Crimi, Nunzio, Maestrelli, Piero, Menzella, Francesco, Milanese, Manlio, Papi, Alberto, Pelaia, Girolamo, Pini, Laura, Santus, Pierachille, Savi, Eleonora, Scichilone, Nicola, Senna, Gianenrico, Spadaro, Giuseppe, Vaghi, Adriano, Gans, Steven, Hölters, Jurgen, Langeveld, B, Pieters, Willem, A Staaks, G H, van Veen, Ilonka, K van den Berg, J W, Einvik, Gunnar, Lehmann, Sverre, Ali García, Ismael, Almonacid, Carlo, Bobolea, Irina, Campo Mozo, Paloma, de Luiz, Gustavo, Domingo Ribas, Christian, María Echave-Sustaeta María-Tomé, José, Luis García Rivero, Juan, García-Cosío Piqueras, Borja, Gómez-Bastero Fernández, Ana, González Pérez, Ruperto, Henríquez Santa, Aythamy, Martínez Rivera, Carlo, Muñoz Gall, Xavier, Ramos, Jacinto, Gregorio Soto Campos, Jose, Vidal Pan, Carmen, Stenfors, Nikolai, Tunsäter, Alf, Vinge, Ine, Chaudhuri, Rekha, Harrison, Timothy, Mansur, Adel, Nasser, Shuaib, Nordstrom, Monica, Pfeffer, Paul, Saralaya, Dinesh, Short, Philip, Adlakha, Arun, Alpan, Oral, Averill, Franci, Badhwar, Anil, Bardelas, Jose, Baxter, Barbara, Bensch, George, Berger, William, Bernstein, Jonathan, Bridges, Tracy, Brimeyer, Ryan, Calhoun, William, Campbell, Edward, Brett Cherry, William, Chupp, Geoffrey, Clore, Lee, Cohn, John, Cole, Jeremy, Condemi, John, Cury, Jame, Davis, Benjamin, Deleon, Samuel, Delacruz, Lui, Diaz, Joseph, Erb, David, Eziri, Emeka, Fakih, Faisal, Fiedler, Dougla, Fost, David, Fritz, Stephen, Gonzalez, Erika, Goodman, Brad, Gottlieb, Peter, Gottschlich, Gregory, Gower, Richard, Hajal, Rizan, Harris, Jame, Heidarian-Raissy, Hengameh, Heyder, Albrecht, Hill, DAVID STANLEY, Holguin, Fernando, Hussain, Iftikhar, Illowite, Jonathan, Jacobs, Joshua, Jarratt, Mikell, Kaiser, Harold, Kao, Neil, Kashyap, Ravindra, Kaufman, David, Kent, Edward, Kim, Kenneth, Klein, Ryan, Kraft, Monica, Kono, Ritsu, Kureishy, Shahrukh, Leflein, Jeffrey, Leong, Mila, Li, Huamin, Lin, Robert, Lugogo, Njira, Marcus, Michael, Jose Maselli Caceres, Diego, Mehta, Vinay, Mello, Curti, Millard, Mark, Milstone, Aaron, Mohan, Arjun, Moore, Wendy, Moss, Mark, Mumneh, Nayla, O'Brien, Thoma, Ostransky, David, Palumbo, Michael, Parikh, Purvi, Parikh, Sudhir, Patel, Amit, Perez, Guido, Pleskow, Warren, Prenner, Bruce, Puppala, Dileep, Ramey, John, Reibman, Joan, Reyes, Ramon, Robinette, Emory, Rodicio, Ileana, Ryan, Stephen, Sekhsaria, Sudhir, Sigal, Barry, Sikand, Vinay, Soong, Weily, Spangenthal, Selwyn, St John, Roy, Gary, Steven, Subramaniam, Vijay, Sumino, Kaharu, Sztejman, Eric, A Tan, Ricardo, Tanus, Tonny, Thompson, Charle, Thornblade, Carl, Villareal, Manuel, Wenzel, Sally, Zafra, Heidi, Ziedalski, Tomasz, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service de pneumologie, Harrison T.W., Chanez P., Menzella F., Canonica G.W., Louis R., Cosio B.G., Lugogo N.L., Mohan A., Burden A., McDermott L., Garcia Gil E., Zangrilli J.G., Pohl W., Voves R., Deschampheleire M., Martinot J.-B., Peche R., Chapman K., Cheema A., Dorscheid D., FitzGerald J.M., Gagnon R., Killorn W.P., Olivenstein R., Philteos G., Ramsey C., Rolf J.D., Walker B., Hilberg O., Skjold T., Titlestad I., Hakulinen A., Kilpelainen M., Ben Hayoun M., Bonniaud P., Bourdin A., De Blay F., Deslee G., Devouassoux G., Didier A., Douadi Y., Fry S., Garcia G., Girodet P.-O., Leroyer C., Magnan A., Mahay G., Nocent C., Pison C., Roux P.-M., Taille C., Tiotiu J.-A., Beck E., Jandl M., Kaehler C., Kassner F., Koesters F., Kronsbein J., Schaum T., Schulz C., Skowasch D., Taube C., Welte T., de Roux A., Beghe B., Blasi F., Carpagnano G., Caruso C., Corsico A.G., Constantino E., Crimi N., Maestrelli P., Milanese M., Papi A., Pelaia G., Pini L., Santus P., Savi E., Scichilone N., Senna G., Spadaro G., Vaghi A., Gans S., Holters J., Langeveld B., Pieters W., Staaks G.H.A., van Veen I., van den Berg J.W.K., Einvik G., Lehmann S., Ali Garcia I., Almonacid C., Bobolea I., Campo Mozo P., de Luiz G., Domingo Ribas C., Echave-Sustaeta Maria-Tome J.M., Garcia Rivero J.L., Garcia-Cosio Piqueras B., Gomez-Bastero Fernandez A., Gonzalez Perez R., Henriquez Santa A., Martinez Rivera C., Munoz Gall X., Ramos J., Gregorio Soto Campos J., Vidal Pan C., Stenfors N., Tunsater A., Vinge I., Chaudhuri R., Harrison T., Mansur A., Nasser S., Nordstrom M., Pfeffer P., Saralaya D., Short P., Adlakha A., Alpan O., Averill F., Badhwar A., Bardelas J., Baxter B., Bensch G., Berger W., Bernstein J., Bridges T., Brimeyer R., Calhoun W., Campbell E., Cherry W.B., Chupp G., Clore L., Cohn J., Cole J., Condemi J., Cury J., Davis B., DeLeon S., Delacruz L., Diaz J., Erb D., Eziri E., Fakih F., Fiedler D., Fost D., Fritz S., Gonzalez E., Goodman B., Gottlieb P., Gottschlich G., Gower R., Hajal R., Harris J., Heidarian-Raissy H., Heyder A., Hill D., Holguin F., Hussain I., Illowite J., Jacobs J., Jarratt M., Kaiser H., Kao N., Kashyap R., Kaufman D., Kent E., Kim K., Klein R., Kraft M., Kono R., Kureishy S., Leflein J., Leong M., Li H., Lin R., Lugogo N., Marcus M., Maselli Caceres D.J., Mehta V., Mello C., Millard M., Milstone A., Moore W., Moss M., Mumneh N., O'Brien T., Ostransky D., Palumbo M., Parikh P., Parikh S., Patel A., Perez G., Pleskow W., Prenner B., Puppala D., Ramey J., Reibman J., Reyes R., Robinette E., Rodicio I., Ryan S., Sekhsaria S., Sigal B., Sikand V., Soong W., Spangenthal S., St. John R., Steven G., Subramaniam V., Sumino K., Sztejman E., Tan R.A., Tanus T., Thompson C., Thornblade C., Villareal M., Wenzel S., Zafra H., Ziedalski T., and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)
Subjects: Pulmonary and Respiratory Medicine, Spirometry, Adult, Male, medicine.medical_specialty, Exacerbation, [SDV]Life Sciences [q-bio], Population, Settore MED/10 - Malattie Dell'Apparato Respiratorio, Placebo, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Double-Blind Method, Internal medicine, medicine, Humans, 030212 general & internal medicine, Anti-Asthmatic Agents, Patient Reported Outcome Measures, education, Sinusitis, Asthma, education.field_of_study, medicine.diagnostic_test, business.industry, Middle Aged, medicine.disease, Benralizumab, 3. Good health, Eosinophils, 030228 respiratory system, chemistry, Asthma Control Questionnaire, Disease Progression, Quality of Life, Female, business
Abstract: Background: ANDHI was done to assess the efficacy of benralizumab, including onset of effect and impact on health-related quality of life (HRQOL), exacerbation rate, lung function, and nasal polyposis symptoms. Methods: This phase 3b, randomised, double-blind, parallel-group, placebo-controlled ANDHI study was completed in adults (aged 18–75 years) with severe eosinophilic asthma with at least 2 exacerbations in the previous year, despite high-dose inhaled corticosteroid plus additional controllers, screening blood eosinophil counts of at least 150 cells per μL, and an Asthma Control Questionnaire 6 (ACQ-6) score of 1·5 or more. Patients who met eligibility criteria were randomly assigned (2:1; stratified by previous exacerbation count [two, or three or more], maintenance oral corticosteroid use, and region), using an integrated web-based response system, to receive benralizumab at 30 mg every 8 weeks (first three doses given 4 weeks apart) or matched placebo for 24 weeks. Primary efficacy measure was annualised asthma exacerbation rate, with rate ratio (RR) calculated over the approximate 24-week follow-up. Secondary efficacy measures included change from baseline to end of treatment (week 24) in St George's Respiratory Questionnaire (SGRQ) total score (key secondary endpoint), FEV1, peak expiratory flow (PEF), ACQ-6, Predominant Symptom and Impairment Assessment (PSIA), Clinician Global Impression of Change (CGI-C), Patient Global Impression of Change (PGI-C), and Sino-Nasal Outcome Test-22 (SNOT-22). All efficacy analyses, except for SNOT-22, were summarised and analysed using the full analysis set on an intention-to-treat population (all randomly assigned patients receiving investigational product, regardless of protocol adherence or continued participation in the study). SNOT-22 was summarised for the subgroup of patients with physician-diagnosed nasal polyposis with informed consent. This study is registered with ClinicalTrials.gov, NCT03170271. Findings: Between July 7, 2017, and Sept 25, 2019, 656 patients received benralizumab (n=427) or placebo (n=229). Baseline characteristics were consistent with severe eosinophilic asthma. Benralizumab significantly reduced exacerbation risk by 49% compared with placebo (RR estimate 0·51, 95% CI 0·39–0·65; p5%) were nasopharyngitis (30 [7%]), headache (37 [9%]), sinusitis (28 [7%]), bronchitis (22 [5%]), and pyrexia (26 [6%]). Fewer serious adverse events were reported for benralizumab (23 [5%]) versus placebo (25 [11%]), and the only common serious adverse event (experienced by >1% of patients) was worsening of asthma, which was reported for nine (2%) patients in the benralizumab group and nine (4%) patients in the placebo group. Interpretation: Our results extend the efficacy profile of benralizumab for patients with severe eosinophilic asthma, showing early clinical benefits in patient-reported outcomes, HRQOL, lung function, and nasal polyposis symptoms. Funding: AstraZeneca.
Published: 2021

250. Surgery after induction chemo or immunotherapy for locally advanced NSCLC

Author: Lococo, Filippo, Sassorossi, Carolina, Mazzarella, Ciro, Vita, Emanuele, Leoncini, Fausto, Martino, Antonella, Nachira, Dania, Chiappetta, Marco, Cesario, Alfredo, Trisolini, Rocco, Bria, Emilio, Margaritora, Stefano, Lococo, Filippo (ORCID:0000-0002-9383-5554), Nachira, Dania (ORCID:0000-0003-2937-9678), Cesario, Alfredo (ORCID:0000-0003-4687-0709), Trisolini, Rocco (ORCID:0000-0002-1067-4696), Bria, Emilio (ORCID:0000-0002-2333-704X), Margaritora, Stefano (ORCID:0000-0002-9796-760X), Lococo, Filippo, Sassorossi, Carolina, Mazzarella, Ciro, Vita, Emanuele, Leoncini, Fausto, Martino, Antonella, Nachira, Dania, Chiappetta, Marco, Cesario, Alfredo, Trisolini, Rocco, Bria, Emilio, Margaritora, Stefano, Lococo, Filippo (ORCID:0000-0002-9383-5554), Nachira, Dania (ORCID:0000-0003-2937-9678), Cesario, Alfredo (ORCID:0000-0003-4687-0709), Trisolini, Rocco (ORCID:0000-0002-1067-4696), Bria, Emilio (ORCID:0000-0002-2333-704X), and Margaritora, Stefano (ORCID:0000-0002-9796-760X)
Published: 2020

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