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1. Risk of Pneumonia in Patients with COPD Initiating Fixed Dose Inhaled Corticosteroid (ICS) / Long-Acting Bronchodilator (LABD) Formulations Containing Extrafine Beclometasone Dipropionate versus Patients Initiating LABD Without ICS

Author

Price D, Henley W, Cançado JED, Fabbri LM, Kerstjens HA, Papi A, Roche N, Şen E, Singh D, Vogelmeier CF, Nudo E, Carter V, Skinner D, Vella R, Soriano JB, Kots M, and Georges G

Subjects
inhaled corticosteroids, pneumonia, copd, extrafine beclometasone, long-acting bronchodilators, Medicine
Abstract

David Price,1,2 William Henley,1,3 José Eduardo Delfini Cançado,4 Leonardo M Fabbri,5 Huib AM Kerstjens,6 Alberto Papi,7 Nicolas Roche,8 Elif Şen,9 Dave Singh,10 Claus F Vogelmeier,11 Elena Nudo,12 Victoria Carter,1 Derek Skinner,1 Rebecca Vella,1 Joan B Soriano,13 Maxim Kots,12 George Georges14 1Observational and Pragmatic Research Institute, Singapore; 2Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; 3Health Statistics Group, Department of Health and Community Sciences, University of Exeter Medical School, Exeter, UK; 4Santa Casa de São Paulo Medical School, São Paulo, Brazil; 5Respiratory Medicine, Department of Translational Medicine and for Romagna, University of Ferrara, Ferrara, Italy; 6Department of Pulmonary Diseases, University of Groningen and University Medical Centre Groningen, and Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, the Netherlands; 7Respiratory Medicine, University of Ferrara, Ferrara, Italy; 8Department of Respiratory Medicine, APHP-Centre University of Paris, Cochin Hospital and Institute (UMR1016), Paris, France; 9Department of Pulmonary Medicine, Ankara University School of Medicine, Ankara, Turkey; 10Division of Infection, Immunity & Respiratory Medicine, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK; 11Department of Internal Medicine, Pulmonary and Critical Care Medicine, University of Marburg, Member of the German Centre for Lung Research (DZL), Marburg, Germany; 12Global Medical Affairs, Chiesi Farmaceutici, S.p.A, Parma, Italy; 13Respiratory Department, Hospital Universitario de La Princesa and Facultad de Medicina, Universidad Autónoma de Madrid, Madrid, Spain; 14Global Clinical Development, Chiesi Farmaceutici, S.p.A, Parma, ItalyCorrespondence: David Price, Observational and Pragmatic Research Institute, 22 Sin Ming Lane, #06-76, Midview City, 573969, Singapore, Tel +65 3105 1489, Email dprice@opri.sgBackground: Combined ICS and long-acting bronchodilators (LABD) more effectively reduce COPD exacerbations than LABD therapy alone. Corticosteroid-related adverse effects, including pneumonia, limit ICS use. Previous data suggest this risk is lower for extrafine beclometasone (ef-BDP). We compared pneumonia risk among new users of fixed dose ICS/LABD formulations containing ef-BDP, versus patients initiating LABD without any ICS.Methods: A propensity-matched historical cohort study design used data from OPCRD. COPD patients with ≥ 1 year of continuous data who initiated LABD or ICS/LABD formulations containing ef-BDP were matched. Primary outcome was time to pneumonia event, as treated, using either sensitive (physician diagnosed) or specific (physician diagnosed and x-ray or hospital admission confirmed) definitions, with non-inferiority boundary of 15%.Results: 23,898 COPD patients were matched, who were 68± 11 years, 54.3% male and 56% current-smokers, while 43% were former-smokers. Initiation of ef-BDP/LABD was not associated with an increased risk of pneumonia versus LABD, for either a sensitive 0.89 (0.78– 1.02), P = 0.08 or a specific 0.91 (0.78– 1.05), P = 0.18 definition of pneumonia. The probability of remaining pneumonia free 1-year after ef-BDP/LABD was 98.4%, which was comparable to LABD at 97.7%, and was sustained up to 6 years of observation; non-inferiority criterion was met for both definitions. Initiation of ef-BDP/LABD was also associated with a reduced risk of developing LRTIs in the propensity matched cohort.Conclusion: Risk of pneumonia when using ICS for the management of COPD reported in several randomised controlled trials may not be relevant with ef-BDP in a diverse real-world clinical population.Keywords: inhaled corticosteroids, pneumonia, COPD, extrafine beclometasone, long-acting bronchodilators

Published
2024

2. Interclass Difference in Pneumonia Risk in COPD Patients Initiating Fixed Dose Inhaled Treatment Containing Extrafine Particle Beclometasone versus Fine Particle Fluticasone

Author

Price DB, Henley W, Cançado JED, Fabbri LM, Kerstjens HA, Papi A, Roche N, Şen E, Singh D, Vogelmeier CF, Barille S, Nudo E, Carter V, Skinner D, Vella R, and Georges G

Subjects
inhaled corticosteroids, pneumonia, copd, extrafine beclomethasone, fluticasone, Diseases of the respiratory system, RC705-779
Abstract

David B Price,1,2 William Henley,1,3 José Eduardo Delfini Cançado,4 Leonardo M Fabbri,5 Huib AM Kerstjens,6 Alberto Papi,7 Nicolas Roche,8 Elif Şen,9 Dave Singh,10 Claus F Vogelmeier,11 Sara Barille,12 Elena Nudo,12 Victoria Carter,1 Derek Skinner,1 Rebecca Vella,1 George Georges13 1Observational and Pragmatic Research Institute, Singapore; 2Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; 3Health Statistics Group, Institute of Health Research, University of Exeter Medical School, Exeter, UK; 4Santa Casa de São Paulo Medical School, São Paulo, Brazil; 5Respiratory Medicine, Department of Translational Medicine, University of Ferrara, Ferrara, Italy; 6Department of Pulmonary Diseases, University of Groningen and University Medical Centre Groningen, and Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, Netherlands; 7Respiratory Medicine, University of Ferrara, Ferrara, Italy; 8Department of Respiratory Medicine, APHP-Centre University of Paris, Cochin Institute, Paris, France; 9Department of Pulmonary Medicine, Ankara University School of Medicine, Ankara, Turkey; 10Division of Infection, Immunity & Respiratory Medicine, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK; 11Department of Internal Medicine, Pulmonary and Critical Care Medicine, University of Marburg, Member of the German Centre for Lung Research (DZL), Marburg, Germany; 12Global Medical Affairs, Chiesi Farmaceutici, S.p.A., Parma, Italy; 13Global Clinical Development, Chiesi Farmaceutici, S.p.A., Parma, ItalyCorrespondence: David B Price, Observational and Pragmatic Research Institute, 22 Sin Ming Lane, #06-76, Midview City, 573969, Singapore, Email dprice@opri.sgBackground: Inhaled corticosteroids (ICS) afford therapeutic benefits in some COPD patients, but their widespread use is cautioned due to an increased risk of developing pneumonia. Subclass variations exist, and the risk profile differs for individual ICS. Formulation particle size has been identified as a potential effect modifier. The present study compared the risk of pneumonia among new COPD users of fixed-dose combination inhalers containing fine-particle fluticasone (fp-FDC-F) versus extrafine particle beclometasone (ef-FDC-BDP).Methods: A propensity matched historical cohort study was conducted using data from the Optimum Patient Care Research Database. COPD patients aged ≥ 40 years with ≥ 1 year of continuous medical data who initiated fp-FDC-F or ef-FDC-BDP were compared. The primary outcome was time to pneumonia event, as treated, using either sensitive (physician diagnosed) or specific (physician diagnosed and x-ray or hospital admission confirmed) definitions.Results: A total of 13,316 patients were matched. Initiation of fp-FDC-F (mean dosage furoate 99 μg; propionate 710 μg) was associated with an increased risk of pneumonia versus ef-FDC-BDP (mean beclometasone dose 395 μg), irrespective of definition (sensitive HR 1.38 95% CI 1.14– 1.68; specific HR 1.31 95% CI 1.05– 1.62).Conclusion: In the current investigation, we found that in comparison to extrafine beclomethasone, commencing a formulation containing fluticasone is associated with an increased risk of developing pneumonia. These observations support the idea that not all ICS are equal in their adverse effects and subclass variations exist and should be carefully considered in the treatment choice.Keywords: inhaled corticosteroids, pneumonia, COPD, extrafine beclomethasone, fluticasone

Published
2022

3. Extrafine Beclometasone Dipropionate/Formoterol Fumarate vs Double Bronchodilation Therapy in Patients with COPD: A Historical Real-World Non-Inferiority Study

Author

Voorham J, Baldi S, Santoro L, Kerkhof M, Contoli M, Fabbri LM, Kerstjens HAM, Luis López-Campos J, Roche N, Singh D, Vogelmeier CF, and Price DB

Subjects
real-world, electronic health records, observational, comparative effectiveness, heterogeneity, chronic obstructive pulmonary disease, Diseases of the respiratory system, RC705-779
Abstract

Jaco Voorham,1,2 Simonetta Baldi,3 Luigi Santoro,4 Marjan Kerkhof,1,5 Marco Contoli,6 Leonardo M Fabbri,6 Huib AM Kerstjens,7 Jose Luis López-Campos,8 Nicolas Roche,9 Dave Singh,10 Claus F Vogelmeier,11 David B Price1,12 1Observational & Pragmatic Research Institute Pte Ltd, Singapore, Singapore; 2Data to Insights Research Solutions, Lisbon, Portugal; 3Department of Global Clinical Development, Chiesi SAS, Bois Colombes Cedex, France; 4Department of Global Clinical Development, Chiesi Farmaceutici S.p.A, Parma, Italy; 5Mescio Research, Blauwestad, The Netherlands; 6Section of Respiratory Medicine, Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy; 7Department of Pulmonary Diseases, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands; 8Respiratory Diseases Unit, University Hospital Virgen Del Rocío, Seville, Spain; 9Service de Pneumologie, Hôpital Cochin, APHP, Centre-Université de Paris, Paris, France; 10University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK; 11Department of Internal Medicine, Pulmonary and Critical Care Medicine, University of Marburg, Member of the German Centre for Lung Research (DZL), Marburg, Germany; 12Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UKCorrespondence: David B PriceAcademic Primary Care, Division of Applied Health Sciences University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen AB25 2ZD 198785, UKTel +65 6962 3627Email dprice@opri.sgPurpose: This study aimed to evaluate the non-inferiority of initiating extrafine beclometasone dipropionate/formoterol fumarate (BDP/FF) versus double bronchodilation (long-acting beta-agonists [LABA]/long-acting muscarinic antagonists [LAMA]) among patients with a history of chronic obstructive pulmonary disease (COPD) exacerbations.Patients and Methods: A historical cohort study was conducted using data from the UK’s Optimum Patient Care Research Database. Patients with COPD ≥ 40 years at diagnosis were included if they initiated extrafine BDP/FF or any LABA/LAMA double therapy as a step-up from no maintenance therapy or monotherapy with inhaled corticosteroids (ICS), LAMA, or LABA and a history of ≥ 2 moderate/severe exacerbations in the previous two years. The primary outcome was exacerbation rate from therapy initiation until a relevant therapy change or end of follow-up. Secondary outcomes included rate of acute respiratory events, acute oral corticosteroids (OCS) courses, and antibiotic prescriptions with lower respiratory indication, modified Medical Research Council score (mMRC) ≥ 2, and time to first pneumonia diagnosis. The non-inferiority boundary was set at a relative difference of 15% on the ratio scale. Five potential treatment effect modifiers were investigated.Results: A total of 1735 patients initiated extrafine BDP/FF and 2450 patients initiated LABA/LAMA. The mean age was 70 years, 51% were male, 41% current smokers, and 85% had FEV1 < 80% predicted. Extrafine BDP/FF showed non-inferiority to LABA/LAMA for rate of exacerbations (incidence rate ratio [IRR] = 1.01 [95% CI 0.94– 1.09]), acute respiratory events (IRR = 0.98 [0.92– 1.04]), acute OCS courses (IRR = 1.01 [0.91– 1.11]), and antibiotic prescriptions (IRR = 0.99 [0.90– 1.09]), but not for mMRC (OR = 0.93 [0.69– 1.27]) or risk of pneumonia (HR = 0.50 [0.14– 1.73]). None of the a priori defined effect modifier candidates affected the comparative effectiveness.Conclusion: This study found that stepping up to extrafine BDP/FF from no maintenance or monotherapy was not inferior to stepping up to double bronchodilation therapy in patients with a history of exacerbations.Keywords: real-world, electronic health records, observational, comparative effectiveness, heterogeneity, chronic obstructive pulmonary disease

Published
2020

4. Extrafine triple therapy delays COPD clinically important deterioration vs ICS/LABA, LAMA, or LABA/LAMA

Author

Singh D, Fabbri LM, Vezzoli S, Petruzzelli S, and Papi A

Subjects
anticholinergics, beta-2 agonists, chronic obstructive pulmonary disease, disease activity, inhaled corticosteroids, Diseases of the respiratory system, RC705-779
Abstract

Dave Singh,1 Leonardo M Fabbri,2,3 Stefano Vezzoli,4 Stefano Petruzzelli,4 Alberto Papi2 1Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK; 2Section of Cardiorespiratory and Internal Medicine, Department of Medical Sciences, University of Ferrara, Ferrara, Italy; 3COPD Center, Institute of Medicine, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden; 4Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy Background: Current pharmacological therapies for COPD improve quality of life and symptoms and reduce exacerbations. Given the progressive nature of COPD, it is arguably more important to understand whether the available therapies are able to delay clinical deterioration; the concept of “clinically important deterioration” (CID) has therefore been developed. We evaluated the efficacy of the single-inhaler triple combination beclometasone dipropionate, formoterol fumarate, and glycopyrronium (BDP/FF/G), using data from three large 1-year studies. Methods: The studies compared BDP/FF/G to BDP/FF (TRILOGY), tiotropium (TRINITY), and indacaterol/glycopyrronium (IND/GLY; TRIBUTE). All studies recruited patients with symptomatic COPD, FEV1

Published
2019

5. Triple therapy (ICS/LABA/LAMA) in COPD: time for a reappraisal

Author

Vanfleteren L, Fabbri LM, Papi A, Petruzzelli S, and Celli B

Subjects
Muscarinic antagonists, adrenergic beta-2 receptor agonists, glucocorticoids, pulmonary disease, chronic obstructive, review, exacerbations, safety, Diseases of the respiratory system, RC705-779
Abstract

Lowie Vanfleteren,1–3 Leonardo M Fabbri,1,4 Alberto Papi,4 Stefano Petruzzelli,5 Bartolome Celli6 1COPD Center, Institute of Medicine, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden; 2CIRO, Horn, the Netherlands; 3Department of Respiratory Medicine, Maastricht University Medical Hospital, Maastricht, the Netherlands; 4Section of Cardiorespiratory and Internal Medicine, Department of Medical Sciences, University of Ferrara, Ferrara, Italy; 5Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy; 6Division of Pulmonary and Critical Care, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA Abstract: Recently, two “fixed triple” single-inhaler combinations of an inhaled corticosteroid (ICS), a long-acting β2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA) have become available for patients with COPD. This review presents the clinical evidence that led to the approval of these triple therapies, discusses the role of ICS in patients with COPD, and presents data on the relative efficacy of “fixed triple” (ICS/LAMA/LABA) therapy vs LAMA, ICS/LABA, and LAMA/LABA combinations, and summarizes studies in which ICS/LABAs were combined with LAMAs to form “open triple” combinations. Of the five main fixed triple studies completed so far, three evaluated the efficacy and safety of an extrafine formulation of beclometasone dipropionate, formoterol fumarate, and glycopyrronium; the other two studies evaluated fluticasone furoate, vilanterol, and umeclidinium. Overall, compared to LAMA, ICS/LABA, or LAMA/LABA, triple therapy decreased the risk of exacerbations and improved lung function and health status, with a favorable benefit-to-harm ratio. Furthermore, triple therapy showed a promising signal in terms of improved survival. The evidence suggests that triple therapy is the most effective treatment in moderate/severe symptomatic patients with COPD at risk of exacerbations, with marginal if any risk of side effects including pneumonia. Ongoing studies are examining the role of triple therapy in less severe symptomatic patients with COPD and asthma–COPD overlap. Keywords: muscarinic antagonists, adrenergic β2 receptor agonists, glucocorticoids, pulmonary disease, chronic obstructive, review, exacerbations, safety

Published
2018

6. Does roflumilast decrease exacerbations in severe COPD patients not controlled by inhaled combination therapy? the REACT study protocol

Author

Calverley PM, Martinez FJ, Fabbri LM, Goehring UM, and Rabe KF

Subjects
Diseases of the respiratory system, RC705-779
Abstract

Peter MA Calverley,1 Fernando J Martinez,2 Leonardo M Fabbri,3 Udo-Michael Goehring,4 Klaus F Rabe5–71Clinical Science Center, University Hospital Aintree, Liverpool, United Kingdom; 2Department of Internal Medicine, University of Michigan, MI, USA; 3Department of Respiratory Diseases, University of Modena and Reggio Emilia, Modena, Italy; 4Nycomed (a Takeda company), Konstanz, Germany; 5University of Kiel, Kiel, Germany; 6Krankenhaus Grosshansdorf, Center for Pulmonology and Thoracic Surgery, Grosshansdorf, Germany; 7Department of Pulmonology, Leiden University Medical Center, Leiden, The NetherlandsBackground: Many patients with chronic obstructive pulmonary disease (COPD) continue to suffer exacerbations, even when treated with maximum recommended therapy (eg, inhaled combinations of long-acting β2-agonist and high dose inhaled corticosteroids, with or without a long-acting anticholinergic [long-acting muscarinic antagonist]). Roflumilast is approved to treat severe COPD in patients with chronic bronchitis – and a history of frequent exacerbations – as an add-on to bronchodilators.Purpose: The REACT (Roflumilast in the Prevention of COPD Exacerbations While Taking Appropriate Combination Treatment) study (identification number RO-2455-404-RD, clinicaltrials.gov identifier NCT01329029) will investigate whether roflumilast further reduces exacerbations when added to inhaled combination therapy in patients still suffering from frequent exacerbations.Patients and methods: REACT is a 1-year randomized, double-blind, multicenter, phase III/IV study of roflumilast 500 µg once daily or placebo on top of a fixed long-acting β2-agonist/inhaled corticosteroid combination. A concomitant long-acting muscarinic antagonist will be allowed at stable doses. The primary outcome is the rate of moderate or severe COPD exacerbations. Using a Poisson regression model with a two-sided significance level of 5%, a sample size of 967 patients per treatment group is needed for 90% power. COPD patients with severe to very severe airflow limitation, symptoms of chronic bronchitis, and at least two exacerbations in the previous year will be recruited.Conclusion: It is hypothesized that because roflumilast (a phosphodiesterase-4 inhibitor) has a different mode of action to bronchodilators and inhaled corticosteroids, it may provide additional benefits when added to these treatments in frequent exacerbators. REACT will be important to determine the role of roflumilast in COPD management. Here, the design and rationale for this important study is described.Keywords: chronic obstructive pulmonary disease, roflumilast, protocol, LABA, ICS, exacerbation

Published
2012

8. Exploring the relevance and extent of small airways dysfunction in asthma: baseline data from the AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS) prospective cohort study

Author

Postma, Dirkje S., Brightling, C, Baldi, S, Van den Berge, M, Fabbri, LM, Gagnatelli, A, Papi, A, Van der Molen, T, Rabe, KF, Siddiqui, S, Singh, Dave, Nicolini, G, and Kraft, M

Subjects
mental disorders, behavioral disciplines and activities, respiratory tract diseases
Abstract

Background Small airways dysfunction (SAD) is well-recognized in asthma, yet its role in asthma severity and asthma control is unclear. Our study aimed to assess which (combination of) biomarkers, physiological testing and imaging markers best measures the presence and extent of SAD in asthma. Methods This multinational observational study investigated participants without and with asthma (GINA severity stage 1-5). Asthma inclusion criteria were: 1) age 18-65 years; 2) clinical asthma diagnosis > 6 months, confirmed by a chest physician 2, supported by objective evidence of any of the following at the baseline visit or in the previous 5 years: a) positive airway hyperresponsiveness to methacholine, or b) positive reversibility (ΔFEV1≥ 12% and ≥ 200 mL within 30 minutes after 400 μg of salbutamol pMDI with or without a spacer or c) PEF variability >20%, measured during 7 days or d) documented reversibility after a cycle (e.g. 4 weeks) of maintenance anti-asthma treatment; 3) stable asthma on any previous regular asthma treatment (“rescue” β2-agonists alone included) at a stable dose for > 8 weeks before baseline; 4) lifetime smoking ≤ 10 pack-years. They underwent spirometry, body plethysmography, impulse oscillometry (IOS), Multiple Breath Nitrogen Washout (MBNW), computed tomography (CT) and questionnaires. Structural equation modeling (SEM) was applied in asthma to assess the contribution of all physiological and CT parameters to SAD. With SEM, we defined a clinical-SAD and CT-SAD score. Asthma subjects were classified in SAD groups using model-based clustering. Asthma severity, control and health care utilization in the past year were compared with the SAD scores and SAD groups. Findings We investigated 773 asthma and 99 control participants (median [interquartiles] age 46 [34, 54] and 41 [29, 52] years, 58% and 57% females, respectively). All physiologic measures contributed to the clinical SAD model with SEM analysis. The prevalence of SAD in asthma was dependent on the measure used and lowest with MBNW Sacin that reflects ventilation heterogeneity in the most peripheral, pre-acinar/acinar airways. IOS and spirometry, reflecting dysfunction of small-to-midsized airways, contributed most to the Clinical-SAD score and differentiated the two SAD Groups. Clinical-SAD Group1 (n=452) had “milder“ SAD, i.e. comparable MBNW Sacin with controls. Group2 (n=312) had more abnormal physiologic SAD measures than Group1, particularly IOS and spirometry, and more severe asthma (asthma control, treatments, exacerbations, quality of life). Clinical-SAD scores were higher in Group2 (“more severe” SAD) and related to asthma control, severity, and exacerbations. Clinical-SAD and CT-SAD scores did not significantly correlate. Interpretation SAD is a complex and silent signature of asthma, which is likely to be directly or indirectly captured by combinations of physiologic tests: spirometry, body plethysmography, IOS, and MBNW. SAD is present across all asthma severity and particularly in severe disease. The clinical classification of SAD in two groups, i.e. a “milder” and “more severe” SAD group, by the easy-to conduct measures IOS and spirometry, is meaningful given its association with GINA asthma severity stages, asthma control, quality of life, and exacerbations. The longitudinal part of ATLANTIS will show the relevance of the SAD score for future risks in asthma, and additionally which parameter best associates with future asthma control. Moreover, we will report on development of a Small Airways Dysfunction Tool (SADT), a questionnaire as an easy measure to suggest SAD, and on the measures of inflammation that best discriminate between the large and small airways’ compartments, with bronchial and transbronchial biopsies, in a smaller subset of participants.

Published
2019

10. Cardiac Diseases and respiratory consequences

Author

Clini, E, Roversi, S, Beghè, B, and Fabbri, Lm.

Subjects
systemic inflammation, ischemic heart disease and heart failure, chronic obstructive lung disease, ischemic heart disease and heart failure, systemic inflammation, chronic obstructive lung disease
Published
2019

13. Reduction in fatal events with extrafine inhaled corticosteroid (ICS)-containing medications: Results of stratified safety pooled analysis of the TRILOGY, TRINITY and TRIBUTE studies

Author

Fabbri, LM, additional, Singh, D, additional, Roche, N, additional, Corradi, M, additional, Guasconi, A, additional, Scuri, M, additional, Montagna, I, additional, Cohuet, G, additional, Francisco, C, additional, Vezzoli, S, additional, Petruzzelli, S, additional, and Papi, A, additional

Published
2019
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17. Antibiotic treatment of severe exacerbations of chronic obstructive pulmonary disease with procalcitonin: a randomized noninferiority trial

Author

Verduri, A, Luppi, F, D'Amico, R, Balduzzi, S, Vicini, R, Liverani, A, Ruggieri, V, Plebani, M, Barbaro, Mp, Spanevello, A, Canonica, Gw, Papi, A, Fabbri, Lm, Beghè, B, FARM58J2XH Study Group: Fabbri LM, Beghé, B, Franco, F, De Carlo MR, Confalonieri, M, Milani, G, Pozzi, E, Luisetti, M, Cerveri, I, Niniano, R, Marsico, S, Calabrese, C, Olivieri, D, Tzani, P, Torre, O, Braido, F, Salerno, F, Carone, M, Zucchi, L, Menzella, F, Castagnetti, C, Paggiaro, Pl, Vagaggini, B, Costa, F, Contoli, M, Marku, B, Cagnazzo, Mg, Crimi, Nunzio, Mastruzzo, C, Ciccarelli, M, Calabro, S, Balestro, E, Rossi, A, Donazzan, G, Bonazza, L, Zuin, R, Pistolesi, M, and Bigazzi, F.

Subjects
Sepsis, C-Reactive Protein, Serum procalcitonin
Published
2015

21. Mancanza di correlazione tra segni radiologici di tubercolosi inattiva e risposta immune specifica nei confronti di M. Tuberculosis in pazienti con malattie ematolinfoproliferative

Author

Fantini, R, Losi, M, Ferrari, A, Luppi, F, Spagnolo, P, D'Amico, R, Torricelli, P, Fiocchi, F, Roversi, P, Cerri, S, Rumpianesi, F, Meacci, M, Meccugni, B, Fabbri LM., T, Luppi, M, Richeldi, L, Fantini R, Losi M, Ferrari A, Luppi F, Spagnolo P, D'Amico R, Torricelli P, Fiocchi F, Roversi P, Cerri S, Rumpianesi F, Meacci M, Meccugni B, Fabbri LM. Torelli G, Luppi M, Richeldi L., Fantini, R, Losi, M, Ferrari, A, Luppi, F, Spagnolo, P, D'Amico, R, Torricelli, P, Fiocchi, F, Roversi, P, Cerri, S, Rumpianesi, F, Meacci, M, Meccugni, B, Fabbri LM., T, Luppi, M, Richeldi, L, Fantini R, Losi M, Ferrari A, Luppi F, Spagnolo P, D'Amico R, Torricelli P, Fiocchi F, Roversi P, Cerri S, Rumpianesi F, Meacci M, Meccugni B, Fabbri LM. Torelli G, Luppi M, and Richeldi L.

Published
2010

22. Adjustable maintenance dosing with budesonide/formoterol in a single inhaler provides effective asthma symptom control at a lower dose than fixed maintenance dosing

Author

Canonica, Giorgio, Castellani, P, Cazzola, M, Fabbri, Lm, Fogliani, V, Mangrella, M, Moretti, A, Paggiaro, P, Sanguinetti, Cm, Vignola, Am, and CAST Study Group

Subjects
Adult, Male, Pulmonary and Respiratory Medicine, Budesonide, medicine.drug_class, Drug Administration Schedule, Formoterol Fumarate, Bronchodilator, medicine, Humans, Pharmacology (medical), Dosing, athma, therapy, guidelines, Asthma, Dose-Response Relationship, Drug, Inhalation, business.industry, Nebulizers and Vaporizers, Inhaler, Biochemistry (medical), medicine.disease, Bronchodilator Agents, respiratory tract diseases, Treatment Outcome, Budesonide/formoterol, Ethanolamines, Anesthesia, Drug Therapy, Combination, Female, Formoterol, business, medicine.drug
Abstract

Asthma guidelines suggest a stepwise approach to maintenance pharmacological treatment of persistent asthma until control is attained, and a 3 month review of the fixed maintenance dosing for step-up or step-down adjustment. This 12-week study compared the efficacy and safety of budesonide/formoterol in a single inhaler (Symbicort Turbuhaler 160/4.5 or 80/4.5 microg) given as adjustable maintenance or fixed maintenance dosing. Patients (n = 2358) were randomised to budesonide/formoterol fixed maintenance dosing (two inhalations bid) or adjustable maintenance dosing (two inhalation bid; stepping up to four inhalations bid if asthma worsened for a maximum of 14 days; stepping down to two inhalations once nocte or one inhalation bid if symptoms were controlled) for 12 weeks, following a 4-week run-in period on budesonide/formoterol two inhalations bid. Primary efficacy variables were frequency of asthma exacerbations and changes in patients' asthma symptom severity. Secondary variables were asthma control, safety and health economics. Both adjustable maintenance dosing and fixed maintenance dosing were associated with similar low frequency of exacerbations (5% both groups; ns) and similarly improved lung function, with similarly fewer nocturnal awakenings and less asthma symptoms compared with the mean value of the run-in period. However, patients on adjustable maintenance dosing used 24% fewer study drug compared with fixed maintenance dosing (2.95 versus 3.86 inhalations daily; p < 0.0001) and incurred in a significant (p

Published
2004

23. Mancanza di correlazione tra segni radiologici di tubercolosi inattiva e risposta immune specifica nei confronti di M. Tuberculosis in pazienti con malattie ematolinfoproliferative

Author

Fantini R, Losi M, Ferrari A, Luppi F, Spagnolo P, D'Amico R, Torricelli P, Fiocchi F, Roversi P, Cerri S, Rumpianesi F, Meacci M, Meccugni B, Fabbri LM. Torelli G, Luppi M, Richeldi L., Fantini, R, Losi, M, Ferrari, A, Luppi, F, Spagnolo, P, D'Amico, R, Torricelli, P, Fiocchi, F, Roversi, P, Cerri, S, Rumpianesi, F, Meacci, M, Meccugni, B, Fabbri LM., T, Luppi, M, and Richeldi, L

Subjects
Malattie ematolinfoproliferative, Tuberculosis, IFN-gamma based tests
Published
2010

24. Moving from the Oslerian paradigm to the postgenomic era: Are asthma and COPD outdated terms?

Author

Vanfleteren, LEGW, Kocks, JWH, Stone, IS, Breyer-Kohansal, R, Greulich, T, Lacedonia, D, Buhl, R, Fabbri, LM, Pavord, ID, Barnes, N, Wouters, EFM, Agusti, A, Pulmonologie, RS: CAPHRI School for Public Health and Primary Care, RS: NUTRIM - R3 - Chronic inflammatory disease and wasting, and RS: CAPHRI - Asthma and COPD

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, Placebo-controlled study, Alternative medicine, PHENOTYPES, AIRWAY DISEASE, Disease, PLACEBO-CONTROLLED TRIAL, OBSTRUCTIVE PULMONARY-DISEASE, THERAPY, COPD Mechanisms, DOUBLE-BLIND, Pulmonary Disease, Chronic Obstructive, Asthma, Terminology as Topic, medicine, Humans, Precision Medicine, Intensive care medicine, INDEX, CLUSTER-ANALYSIS, COPD, business.industry, Systems Biology, medicine.disease, LUNG-FUNCTION, Systems medicine, EXACERBATIONS, Phenotype, Physical therapy, Health education, Personalized medicine, business
Abstract

In the majority of cases, asthma and chronic obstructive pulmonary disease (COPD) are two clearly distinct disease entities. However, in some patients there may be significant overlap between the two conditions. This constitutes an important area of concern because these patients are generally excluded from randomised controlled trials (mostly because of smoking history in the case of asthma or because of significant bronchodilator reversibility in the case of COPD). As a result, their pathobiology, prognosis and response to therapy are largely unknown. This may lead to suboptimal management and can limit the development of more personalised therapeutic options. Emerging genetic and molecular information coupled with new bioinformatics capabilities provide novel information that can pave the way towards a new taxonomy of airway diseases. In this paper we question the current value of the terms 'asthma' and 'COPD' as still useful diagnostic labels; discuss the scientific and clinical progress made over the past few years towards unravelling the complexity of airway diseases, from the definition of clinical phenotypes and endotypes to a better understanding of cellular and molecular networks as key pathogenic elements of human diseases (so-called systems medicine); and summarise a number of ongoing studies with the potential to move the field towards a new taxonomy of airways diseases and, hopefully, a more personalised approach to medicine, in which the focus will shift from the current goal of treating diseases as best as possible to the so-called P4 medicine, a new type of medicine that is predictive, preventive, personalised and participatory.

Published
2014

25. The Inhaled Steroid Treatment As Regular Therapy in Early Asthma (START) study 5-year follow-up: effectiveness of early intervention with budesonide in mild persistent asthma

Author

BUSSE WW, PEDERSEN S, PAUWELS RA, TAN WC, CHEN YZ, LAMM CJ, Eckmayr J, Riedler J, Wurzinger G, Ott G, Zarkovic J, Schulheim A, Götz M, Schinko H, Thomüller I, de Backer W, van Bever H, Verleden G, de Boeck C, Aumann J, Vincken W, Dab I, de Vuyst P, de Jonghe M, Casimir G, Joos G, de Baets F, Bogaerts Y, Halloy JL, Bartsch P, Thiriaux J, Pohunek P, Rybníćek O, Skopková O, Pavelková L, Broź P, Ohnutková E, Novotná B, Baly J, Krćmová I, Kuralová Z, Koćí T, Honomichlová H, Kaśák V, Panzner P, Vondra V, Némećková J, Seberová E, Sykora T, Vít P, Turzíková J, Sörensen T, Neldam S, Peter J, Kludt J, Hansen UB, Knudsen T, Schultz PJ, Rost D, Jensen F, Kinnula V, Saarelainen P, Eho Remes M, Valovirta E, Venho KK, Kokko E, Järvinen M, Toljamo T, Taivainen A, Kava T, Herrala J, Kuusela AL, Nordgren P, Syvänen P, Godard P, Rufin P, Anton M, Aubert JP, Grosclaude M, Brambilla C, Archaud P, Racineux JL, Muir JF, Albertini M, Le Roux P, Simmons A, Bartuschka B, von Berg A, Bergmann V, Berns J, Bisping Arnold A, Blum HC, Garanin G, Brückner OJ, Burbach P, Sudhoff H, Feldmann M, Schmoller T, Wozny HW, Galaske R, Huptas M, Kaecke J, Köcher V, Laule Peschel M, Lohr E, Goldberg J, Drescher T, Reeh W, Rabe U, Rehn L, Scheffler NK, Steinmetz KO, Stutz PM, Weber HH, Uhde C, Ullner R, Vehar H, Krohn EU, Orosz M, Devai A, Uhereczky G, Rajkay K, Gönczi F, Györi E, Dobra G, Puha K, Sztancsik Z, Gömöri K, Dolinay T, Bittera I, Palinkasi S, Cseke Z, Bisits M, Bjämer D, Holme JI, Langhammer A, Hunstad K, Holmboe JH, Grangård E, Solberg DA, Grönneröd TA, Salkowitsch MB, Oymar K, Iversen K, Szczeklik A, Chyrek Borowska S, Mincewicz G, Malaczynska T, Latos T, Obtulowicz K, Emeryk A, Gorski P, Nowak D, Szmidt M, Alkiewicz J, Ziolo G, Spychalski L, Chmielewska Szewczyk D, Nowacka K, Pirozynski M, Prokurat H, Boznanski A, Malolepszy J, Rogala E, Kozielski J, Eriksson UL, Wahlestedt H, Selberg M, Larsson R, Rignér K, Alm B, Aronsson M, Winnergård I, Lagerwall M, Martinsons U, Berlin L, Rydberg B, Weston D, Johnson ME, Barrett C, Siafakas N, Mantzourani E, Orphanidou D, Trakopoulos G, Tzannes S, Kotsovoulou V, Dimadi M, Amfilochiou A, Priftis K, Papageorgiou Saxoni F, Christaki P, Tsanakas I, Paraskevi M, Bousmoukilia S, Spiropoulos K, Anthrakopoulos M, Roussos C, Bentur Alkouby L, Heimer D, Tal A, Horowitz I, Soferman R, Katz Y, Stav D, Weiler Z, Bibi H, Rottem M, Mandelberg A, Geller C, Roizin H, Weiler Ravell D, Kramer MR, Schwartz Y, Rossi A, Foresi A, Giuntini C, Bisetti A, Scoditti S, Tranfa C, Zacchello F, Giovannini M, Boner A, Fabbri LM, Girbino G, Barberio G, Cacciari E, Montefort S, Parascandalo R, Pato R, de Lourdes Chieira M, Moreira C, Chieira DS, Brito U, Borges FD, Marques AC, Figueiredo MM, Dias F, de Almeida AB, Cesar Ramos J, Valente MJ, Pereira JD, Nunes C, Riberio MF, Marques A, Carvalho MQ, de Azevedo MV, de Almeida AR, Pinto JA, Matos Mde F, Afonso A, Dos Santos JM, Fernandez CV, Agustin IC, Bejarano JM, Santos AA, Font ET, Huet EH, Lorente TL, Pujol MM, Munoz AP, Aineto PS, Forns SB, Areu JB, Casan P, Garcia JM, Rodriguez AV, Segura PA, Gil RS, Ciscar CP, Garcia JF, Jimenez TV, Gonzalez JI, Andres FQ, Bueno TA, Baticon CO, Miguel CR, Garcia FD, Hernando HV, Vina AL, Matia RA, Cumplido AS, Andueza MC, Cabra MS, Navarro PL, Rodriguez FA, Li JH, Landry D, O'Keefe D, Muram BF, Conter HS, Tweel D, Peters SD, Adelglass J, Baker JW, Berger WE, Bernstein DI, Blake KV, Amelong P, Casale TB, Charous BL, Chervinsky P, Condemi JJ, Cook D, Creticos PS, de Graff AC Jr, Smith T, Ellis MH, Grossman J, Halverson PC, Galant S, Hollingsworth H, Jackson C, Jacobs RL, Welch M, Kraemer MJ, Leflein J, Lemanske RF, Liebhaber MI, Lockey R, Kelly B, Mendelson L, Nayak A, Pearlman DS, Ruff M, Schwartz B, Scott MB, Shapiro GG, Silk HJ, Skoner DP, Stoloff S, Swamy KN, Atkins FM, Szefler SJ, Vandewalker M, Wald J, Weinstein SF, Wong DA, Wu F, Goldstein S, Murthy KC, Dolmann A, Gene R, Casas JC, Piovano C, Segal E, Balanzat AM, Taborda J, Truganti A, Teper A, Garrood J, Patel MJ, Hogan C, Russel G, Zhu YJ, Cao L, Liu SY, Miao JZ, Ding DJ, Yao WZ, Liu YN, Chen P, Kong SQ, Pang L, Sun B, Li ZM, Li GS, Chen PL, Zhu Q, Zhang TX, Wang XH, Wei S, Deng WW, Zhou X, Ji YY, Luo WT, Li Q, Zhu HR, Sheng JY, Ma JY, Zhang DP, Ji CZ, Xia XR, Zhang ZY, Yin KS, Yiang J, Li Y, Tang PW, Liu FG, Wang HP, Zhong NS, Rong ZS, Tang YC, Lin CY, Liu JS, Liu HZ, Cai DM, Yang JC, Ma QF, Mangunnegoro H, Wijono CA, Tobing NH, Rahajoe NN, Sugito, Surjanto E, Hisyam B, Alsagaff H, Santosa G, Kim YY, Park CS, Kim MK, Cho YJ, Choi DC, Jee YK, Mohan J, Yogeswery S, Wong SL, Kuan GL, Koh CT, Quah BS, de Bruyne J, Liam CK, Avila MM, Cuevas F, Chavaje N, Topete LA, Badillo I, Ponce M, Merida JC, Espinosa AG, Ledezma JM, García JA, Morales GG, Gomez JM, Martinez FJ, Ramos JE, Dorantes JR, Gonzalez CC, Vera JG, Bayardo RG, Melendez AP, Loyola CB, Suárez MA, de Guia T, Balgos A, Bautista N, Realiza T, Diaz D, Yu C, Mendoza Wi JA, Juaneza R, Bigornia R, Mansukhani P, Cacanindin DN, Wah LB, Hon YK, Yau OY, Moh CO, Tang WY, Dippenaar YD, Kirsten DL, Maraschin EF, Ossip MS, Visser SS, Mouton WL, Mercer M, Cassim KM, Macleod AH, Bateman ED, Leaver R, Morison A, Nel H, von Delft KH, Vermeulen JH, Weinberg EG, Lund RJ, Weber HC, Kuo SH, Kuo HP, Wang JL, Hsiue TR, Wang JH, Ching CD, Vangveeravong M, Pothiratana C, Trakultivakorn M, Kongpanichkul A, Thamanavat B, Fuangtong R, Suntornlohanakul S, Youngchaiyud P, Teeratakulpisarn J, Boonsawat W, Viriyachaiyo V, Direkwattanachai C, Visitsunthorn N., MIRAGLIA DEL GIUDICE, Michele, Busse, Ww, Pedersen, S, Pauwels, Ra, Tan, Wc, Chen, Yz, Lamm, Cj, Eckmayr, J, Riedler, J, Wurzinger, G, Ott, G, Zarkovic, J, Schulheim, A, Götz, M, Schinko, H, Thomüller, I, de Backer, W, van Bever, H, Verleden, G, de Boeck, C, Aumann, J, Vincken, W, Dab, I, de Vuyst, P, de Jonghe, M, Casimir, G, Joos, G, de Baets, F, Bogaerts, Y, Halloy, Jl, Bartsch, P, Thiriaux, J, Pohunek, P, Rybníćek, O, Skopková, O, Pavelková, L, Broź, P, Ohnutková, E, Novotná, B, Baly, J, Krćmová, I, Kuralová, Z, Koćí, T, Honomichlová, H, Kaśák, V, Panzner, P, Vondra, V, Némećková, J, Seberová, E, Sykora, T, Vít, P, Turzíková, J, Sörensen, T, Neldam, S, Peter, J, Kludt, J, Hansen, Ub, Knudsen, T, Schultz, Pj, Rost, D, Jensen, F, Kinnula, V, Saarelainen, P, Eho Remes, M, Valovirta, E, Venho, Kk, Kokko, E, Järvinen, M, Toljamo, T, Taivainen, A, Kava, T, Herrala, J, Kuusela, Al, Nordgren, P, Syvänen, P, Godard, P, Rufin, P, Anton, M, Aubert, Jp, Grosclaude, M, Brambilla, C, Archaud, P, Racineux, Jl, Muir, Jf, Albertini, M, Le Roux, P, Simmons, A, Bartuschka, B, von Berg, A, Bergmann, V, Berns, J, Bisping Arnold, A, Blum, Hc, Garanin, G, Brückner, Oj, Burbach, P, Sudhoff, H, Feldmann, M, Schmoller, T, Wozny, Hw, Galaske, R, Huptas, M, Kaecke, J, Köcher, V, Laule Peschel, M, Lohr, E, Goldberg, J, Drescher, T, Reeh, W, Rabe, U, Rehn, L, Scheffler, Nk, Steinmetz, Ko, Stutz, Pm, Weber, Hh, Uhde, C, Ullner, R, Vehar, H, Krohn, Eu, Orosz, M, Devai, A, Uhereczky, G, Rajkay, K, Gönczi, F, Györi, E, Dobra, G, Puha, K, Sztancsik, Z, Gömöri, K, Dolinay, T, Bittera, I, Palinkasi, S, Cseke, Z, Bisits, M, Bjämer, D, Holme, Ji, Langhammer, A, Hunstad, K, Holmboe, Jh, Grangård, E, Solberg, Da, Grönneröd, Ta, Salkowitsch, Mb, Oymar, K, Iversen, K, Szczeklik, A, Chyrek Borowska, S, Mincewicz, G, Malaczynska, T, Latos, T, Obtulowicz, K, Emeryk, A, Gorski, P, Nowak, D, Szmidt, M, Alkiewicz, J, Ziolo, G, Spychalski, L, Chmielewska Szewczyk, D, Nowacka, K, Pirozynski, M, Prokurat, H, Boznanski, A, Malolepszy, J, Rogala, E, Kozielski, J, Eriksson, Ul, Wahlestedt, H, Selberg, M, Larsson, R, Rignér, K, Alm, B, Aronsson, M, Winnergård, I, Lagerwall, M, Martinsons, U, Berlin, L, Rydberg, B, Weston, D, Johnson, Me, Barrett, C, Siafakas, N, Mantzourani, E, Orphanidou, D, Trakopoulos, G, Tzannes, S, Kotsovoulou, V, Dimadi, M, Amfilochiou, A, Priftis, K, Papageorgiou Saxoni, F, Christaki, P, Tsanakas, I, Paraskevi, M, Bousmoukilia, S, Spiropoulos, K, Anthrakopoulos, M, Roussos, C, Bentur Alkouby, L, Heimer, D, Tal, A, Horowitz, I, Soferman, R, Katz, Y, Stav, D, Weiler, Z, Bibi, H, Rottem, M, Mandelberg, A, Geller, C, Roizin, H, Weiler Ravell, D, Kramer, Mr, Schwartz, Y, Rossi, A, Foresi, A, Giuntini, C, Bisetti, A, Scoditti, S, Tranfa, C, Zacchello, F, Giovannini, M, Boner, A, MIRAGLIA DEL GIUDICE, Michele, Fabbri, Lm, Girbino, G, Barberio, G, Cacciari, E, Montefort, S, Parascandalo, R, Pato, R, de Lourdes Chieira, M, Moreira, C, Chieira, D, Brito, U, Borges, Fd, Marques, Ac, Figueiredo, Mm, Dias, F, de Almeida, Ab, Cesar Ramos, J, Valente, Mj, Pereira, Jd, Nunes, C, Riberio, Mf, Marques, A, Carvalho, Mq, de Azevedo, Mv, de Almeida, Ar, Pinto, Ja, Matos Mde, F, Afonso, A, Dos Santos, Jm, Fernandez, Cv, Agustin, Ic, Bejarano, Jm, Santos, Aa, Font, Et, Huet, Eh, Lorente, Tl, Pujol, Mm, Munoz, Ap, Aineto, P, Forns, Sb, Areu, Jb, Casan, P, Garcia, Jm, Rodriguez, Av, Segura, Pa, Gil, R, Ciscar, Cp, Garcia, Jf, Jimenez, Tv, Gonzalez, Ji, Andres, Fq, Bueno, Ta, Baticon, Co, Miguel, Cr, Garcia, Fd, Hernando, Hv, Vina, Al, Matia, Ra, Cumplido, A, Andueza, Mc, Cabra, M, Navarro, Pl, Rodriguez, Fa, Li, Jh, Landry, D, O'Keefe, D, Muram, Bf, Conter, H, Tweel, D, Peters, Sd, Adelglass, J, Baker, Jw, Berger, We, Bernstein, Di, Blake, Kv, Amelong, P, Casale, Tb, Charous, Bl, Chervinsky, P, Condemi, Jj, Cook, D, Creticos, P, de Graff AC, Jr, Smith, T, Ellis, Mh, Grossman, J, Halverson, Pc, Galant, S, Hollingsworth, H, Jackson, C, Jacobs, Rl, Welch, M, Kraemer, Mj, Leflein, J, Lemanske, Rf, Liebhaber, Mi, Lockey, R, Kelly, B, Mendelson, L, Nayak, A, Pearlman, D, Ruff, M, Schwartz, B, Scott, Mb, Shapiro, Gg, Silk, Hj, Skoner, Dp, Stoloff, S, Swamy, Kn, Atkins, Fm, Szefler, Sj, Vandewalker, M, Wald, J, Weinstein, Sf, Wong, Da, Wu, F, Goldstein, S, Murthy, Kc, Dolmann, A, Gene, R, Casas, Jc, Piovano, C, Segal, E, Balanzat, Am, Taborda, J, Truganti, A, Teper, A, Garrood, J, Patel, Mj, Hogan, C, Russel, G, Zhu, Yj, Cao, L, Liu, Sy, Miao, Jz, Ding, Dj, Yao, Wz, Liu, Yn, Chen, P, Kong, Sq, Pang, L, Sun, B, Li, Zm, Li, G, Chen, Pl, Zhu, Q, Zhang, Tx, Wang, Xh, Wei, S, Deng, Ww, Zhou, X, Ji, Yy, Luo, Wt, Li, Q, Zhu, Hr, Sheng, Jy, Ma, Jy, Zhang, Dp, Ji, Cz, Xia, Xr, Zhang, Zy, Yin, K, Yiang, J, Li, Y, Tang, Pw, Liu, Fg, Wang, Hp, Zhong, N, Rong, Z, Tang, Yc, Lin, Cy, Liu, J, Liu, Hz, Cai, Dm, Yang, Jc, Ma, Qf, Mangunnegoro, H, Wijono, Ca, Tobing, Nh, Rahajoe, Nn, Sugito, Surjanto, E, Hisyam, B, Alsagaff, H, Santosa, G, Kim, Yy, Park, C, Kim, Mk, Cho, Yj, Choi, Dc, Jee, Yk, Mohan, J, Yogeswery, S, Wong, Sl, Kuan, Gl, Koh, Ct, Quah, B, de Bruyne, J, Liam, Ck, Avila, Mm, Cuevas, F, Chavaje, N, Topete, La, Badillo, I, Ponce, M, Merida, Jc, Espinosa, Ag, Ledezma, Jm, García, Ja, Morales, Gg, Gomez, Jm, Martinez, Fj, Ramos, Je, Dorantes, Jr, Gonzalez, Cc, Vera, Jg, Bayardo, Rg, Melendez, Ap, Loyola, Cb, Suárez, Ma, de Guia, T, Balgos, A, Bautista, N, Realiza, T, Diaz, D, Yu, C, Mendoza Wi, Ja, Juaneza, R, Bigornia, R, Mansukhani, P, Cacanindin, Dn, Wah, Lb, Hon, Yk, Yau, Oy, Moh, Co, Tang, Wy, Dippenaar, Yd, Kirsten, Dl, Maraschin, Ef, Ossip, M, Visser, S, Mouton, Wl, Mercer, M, Cassim, Km, Macleod, Ah, Bateman, Ed, Leaver, R, Morison, A, Nel, H, von Delft, Kh, Vermeulen, Jh, Weinberg, Eg, Lund, Rj, Weber, Hc, Kuo, Sh, Kuo, Hp, Wang, Jl, Hsiue, Tr, Wang, Jh, Ching, Cd, Vangveeravong, M, Pothiratana, C, Trakultivakorn, M, Kongpanichkul, A, Thamanavat, B, Fuangtong, R, Suntornlohanakul, S, Youngchaiyud, P, Teeratakulpisarn, J, Boonsawat, W, Viriyachaiyo, V, Direkwattanachai, C, and Visitsunthorn, N.

Published
2008

27. Occurrence and impact of chronic obstructive pulmonary disease in elderly patients with stable heart failure

Author

Boschetto, Piera, Fucili, Alessandro, Stendardo, Mariarita, Malagù, M, Parrinello, G, Casimirri, Enrico, Potena, Alfredo, Ballerin, L, Fabbri, Lm, Ferrari, Roberto, and Ceconi, Claudio

Subjects
Aged, 80 and over, Heart Failure, Male, respiratory diseases, heart failure, Middle Aged, Prognosis, Cohort Studies, Pulmonary Disease, Chronic Obstructive, Spirometry, Humans, Female, Aged, Follow-Up Studies, Proportional Hazards Models
Abstract

The coexistence of chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) increases with age. The occurrence, prognosis and therapeutic implications of concurrent COPD in elderly patients with CHF were investigated.One hundred and eighteen consecutive patients, ≥ 65 years old with ≥ 10 pack/years of smoking and with a verified diagnosis of CHF in stable condition, were enrolled. They were followed for a mean of 1029 (range 758-1064) days. All patients had spirometry and the diagnosis and classification of COPD were made according to Global Initiative for Chronic Obstructive Lung Disease guidelines.The mean occurrence of COPD was 30% (90% confidence interval: 24-37%). At baseline in patients with CHF and COPD, there was a shorter 6-min walk distance, lower arterial oxygen tension, glomerular filtration rate and higher N-terminal pro-B-type natriuretic peptide (all P0.05). The prescription of CHF therapies, including β-blockers, was similar in the two groups. After follow up, the presence of COPD in patients with CHF did not appear to influence survival.COPD is relatively frequent in elderly patients with CHF. COPD did not alter survival.

Published
2013

29. Tiotropium versus salmeterol for the prevention of exacerbations of COPD

Author

Vogelmeier C, Hederer B, Glaab T, Schmidt H, Rutten-van Mölken MP, Beeh KM, Rabe KF, Fabbri LM, and POET-COPD Investigators

Subjects
respiratory tract diseases
Abstract

Treatment guidelines recommend the use of inhaled long-acting bronchodilators to alleviate symptoms and reduce the risk of exacerbations in patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD) but do not specify whether a long-acting anticholinergic drug or a ß(2)-agonist is the preferred agent. We investigated whether the anticholinergic drug tiotropium is superior to the ß(2)-agonist salmeterol in preventing exacerbations of COPD.

Published
2011

34. Use of Quantiferon-TB in tube test in the diagnosis of non tuberculous mycobacteria lung disease

Author

Losi M, Fabio A, Dal Monte P, Peracchi M, Del Giovane P, Meacci M, Luppi F, Cerri S, Lombardi G, Fallico L, Apice MG, Spagnolo P, Rumpianesi F, Manganelli R, Fabbri LM, Richeldi L., Losi, M, Fabio, A, Dal Monte, P, Peracchi, M, Del Giovane, P, Meacci, M, Luppi, F, Cerri, S, Lombardi, G, Fallico, L, Apice, M, Spagnolo, P, Rumpianesi, F, Manganelli, R, Fabbri, L, and Richeldi, L

Subjects
Non tuberculous mycobacteria, Interferon-gamma based test
Published
2010

35. Diagnosis of latent tuberculosis in children immigrants from countries with high tuberculosis prevalence

Author

Bergamini, BM, Losi, M, Del Giovane, C, Meacci, M, Luppi, F, Venturelli, C, D’Amico, R, Spagnolo, P, Meccugni, B, Cerri, S, Codifava, M, Rumpianesi, F, Paolucci, P, Fabbri, LM, Richeldi, L, Bergamini, B, Losi, M, Del Giovane, C, Meacci, M, Luppi, F, Venturelli, C, D’Amico, R, Spagnolo, P, Meccugni, B, Cerri, S, Codifava, M, Rumpianesi, F, Paolucci, P, Fabbri, L, and Richeldi, L

Subjects
Latent tuberculosis infection, children immigrants
Published
2010

37. Clusterin (CLU) and lung cancer

Author

Panico, F, Rizzi, F, Fabbri, LM, Bettuzzi, S, Luppi, F, Panico, F, Rizzi, F, Fabbri, L, Bettuzzi, S, and Luppi, F

Subjects
Lung Neoplasms, Prognosi, analysis/antagonists /&/ inhibitors/genetics/physiology, Small Interfering, Prognosis, Lung Neoplasm, Neoplasm Metastasi, Clusterin, analysis/antagonists /&/ inhibitors/genetics/physiology, Disease Progression, Humans, Lung Neoplasms, etiology/pathology/therapy, Neoplasm Metastasis, Prognosis, RNA, genetics, Disease Progression, RNA, Humans, etiology/pathology/therapy, Neoplasm Metastasis, RNA, Small Interfering, Human
Abstract

Lung cancer is the leading cause of cancer-related mortality. It is categorized into two histological groups that have distinct clinical behaviors, the nonsmall cell lung cancers (NSCLC) and the small cell lung cancer (SCLC). When identified at an early stage, NSCLC is treated by surgical resection. However, patients who undergo surgical resection still have a relative low survival rate, primarily for tumor recurrence. Unfortunately, advances in cytotoxic therapy have reached a plateau and new approaches to treatment are needed together with new and better parameters for more accurate prediction of the outcome and more precise indication of the efficacy of the treatment. Several in vitro studies have examined the role of Clusterin (CLU) in carcinogenesis, lung cancer progression, and response to chemo- and radiotherapy. Studies performed in lung cancer cell lines and animal models showed that CLU is upregulated after exposure to chemo- and radiotherapy. A potential role proposed for the protein is cytoprotective. In vitro, CLU silencing by antisense oligonucleotides (ASO) and small-interfering RNAs (siRNA) directed against CLU mRNA in CLU-rich lung cancer cell lines sensitized cells to chemotherapy and radiotherapy and decreased their metastatic potential. In vivo, a recent work analyzed the prognostic role of CLU in NSCLC, showing that CLU-positive patients with lung cancer had a better overall survival and disease-free survival than those with CLU-negative tumors. These data are contradictory to the promising in vitro results. From the results of these studies we may hypothesize that in early-stage lung cancers CLU represents a positive biomarker correlating with better overall survival. In advanced patients, already treated with chemo- and radiotherapy, the induction of CLU may confer resistance to the treatments. However, many studies are needed to better understand the role of CLU in early-stage and advanced lung cancers with the aim to discriminate patients and specific local conditions that could benefit for a CLU knocking down treatment.

Published
2009

38. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials

Author

Fabbri LM, Calverley PM, Izquierdo-Alonso JL, Bundschuh DS, Brose M, Martinez FJ, Rabe KF, and M2-127 and M2-128 study groups

Subjects
respiratory tract diseases
Abstract

Patients with chronic obstructive pulmonary disease (COPD) have few options for treatment. The efficacy and safety of the phosphodiesterase-4 inhibitor roflumilast have been investigated in studies of patients with moderate-to-severe COPD, but not in those concomitantly treated with longacting inhaled bronchodilators. The effect of roflumilast on lung function in patients with COPD that is moderate to severe who are already being treated with salmeterol or tiotropium was investigated.

Published
2009

40. Pharmacological prevention of COPD exacerbations

Author

Beghè B, Luppi F, Fabbri LM, Wedzicha W, Martinez FJ, Beghè, B, Luppi, F, and Fabbri, L

Subjects
Chronic Obstructive Pulmonary Disease, Exacerbations, Pharmacological Prevention
Published
2009

41. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials

Author

Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ, and M2-124 and M2-125 study groups

Subjects
respiratory tract diseases
Abstract

The phosphodiesterase-4 inhibitor roflumilast can improve lung function and prevent exacerbations in certain patients with chronic obstructive pulmonary disease (COPD). We therefore investigated whether roflumilast would reduce the frequency of exacerbations requiring corticosteroids in patients with COPD.

Published
2009

43. Prior tuberculin skin test does not induce a false positive result of T-cell interferon-gamma release assays

Author

Losi M, Ferrara G, Luppi F, Piro R, Cerri S, Tallarico S, Andreani A, D’Amico R, Roversi P, Meacci M, Meccugni B, Marchetti Dori I, Caracciolo R, Fabbri LM, Richeldi L, Losi, M, Ferrara, G, Luppi, F, Piro, R, Cerri, S, Tallarico, S, Andreani, A, D’Amico, R, Roversi, P, Meacci, M, Meccugni, B, Marchetti Dori, I, Caracciolo, R, Fabbri, L, and Richeldi, L

Subjects
Tuberculin skin test, T-cell interferon-gamma release assays
Published
2008

44. T-cell Interferon-gamma-release assays performance to detect latent tuberculosis infection in immunocompromised patients

Author

Losi M, Luppi F, Roversi P, Ferrara G, Cerri S, Ferrari A, D’Amico R, Codeluppi M, Meacci M, Luppi M, Torelli G, Fabbri LM, Richeldi L., Losi, M, Luppi, F, Roversi, P, Ferrara, G, Cerri, S, Ferrari, A, D’Amico, R, Codeluppi, M, Meacci, M, Luppi, M, Torelli, G, Fabbri, L, and Richeldi, L

Subjects
T-cell Interferon-gamma-release assays, immunocompromised patients
Published
2008

47. Rescue use of beclomethasone and albuterol in a single inhaler for mild asthma

Author

Papi, A, Canonica, Giorgio, Maestrelli, P, Paggiaro, P, Olivieri, D, Pozzi, E, Crimi, N, Vignola, Am, Morelli, P, Nicolini, G, Fabbri, Lm, and BEST Study Group

Subjects
Adult, Male, Combination therapy, medicine.drug_class, Peak Expiratory Flow Rate, Placebo, law.invention, Double-Blind Method, Randomized controlled trial, immune system diseases, law, Forced Expiratory Volume, Bronchodilator, Administration, Inhalation, Humans, Medicine, Albuterol, Anti-Asthmatic Agents, Glucocorticoids, Asthma, Inhalation, business.industry, Nebulizers and Vaporizers, Inhaler, Beclomethasone, General Medicine, asthma, Adrenergic beta-Agonists, Middle Aged, medicine.disease, respiratory tract diseases, Drug Combinations, Anesthesia, Salbutamol, Female, Beclomethasone/albuterol, business, medicine.drug
Abstract

Treatment guidelines recommend the regular use of inhaled corticosteroids for patients with mild persistent asthma. We investigated whether the symptom-driven use of a combination of beclomethasone dipropionate and albuterol (also known as salbutamol) in a single inhaler would be as effective as the regular use of inhaled beclomethasone and superior to the as-needed use of inhaled albuterol.We conducted a 6-month, double-blind, double-dummy, randomized, parallel-group trial. After a 4-week run-in, patients with mild asthma were randomly assigned to receive one of four inhaled treatments: placebo twice daily plus 250 microg of beclomethasone and 100 microg of albuterol in a single inhaler as needed (as-needed combination therapy); placebo twice daily plus 100 microg of albuterol as needed (as-needed albuterol therapy); 250 microg of beclomethasone twice daily and 100 microg of albuterol as needed (regular beclomethasone therapy); or 250 microg of beclomethasone and 100 microg of albuterol in a single inhaler twice daily plus 100 microg of albuterol as needed (regular combination therapy). The primary outcome was the morning peak expiratory flow rate.In 455 patients with mild asthma who had a forced expiratory volume in 1 second of 2.96 liters (88.36% of the predicted value), the morning peak expiratory flow rate during the last 2 weeks of the 6-month treatment was higher (P=0.04) and the number of exacerbations during the 6-month treatment was lower (P=0.002) in the as-needed combination therapy group than in the as-needed albuterol therapy group, but the values in the as-needed combination therapy group were not significantly different from those in the groups receiving regular beclomethasone therapy or regular combination therapy. The cumulative dose of inhaled beclomethasone was lower in the as-needed combination therapy group than in the groups receiving regular beclomethasone therapy or regular combination therapy (P0.001 for both comparisons).In patients with mild asthma, the symptom-driven use of inhaled beclomethasone (250 microg) and albuterol (100 microg) in a single inhaler is as effective as regular use of inhaled beclomethasone (250 microg twice daily) and is associated with a lower 6-month cumulative dose of the inhaled corticosteroid. (ClinicalTrials.gov number, NCT00382889 [ClinicalTrials.gov].).

Published
2007

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