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489 results on '"Dusser, D."'

1. Treatment of exacerbations as a predictor of subsequent outcomes in patients with COPD

Author

Calverley PMA, Anzueto AR, Dusser D, Mueller A, Metzdorf N, and Wise RA

Subjects
tiotropium, TIOSPIR®, severity, exacerbations of COPD, hospitalization, Diseases of the respiratory system, RC705-779
Abstract

Peter MA Calverley,1 Antonio R Anzueto,2 Daniel Dusser,3 Achim Mueller,4 Norbert Metzdorf,5 Robert A Wise6 1Clinical Science Centre, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK; 2Pulmonary/Critical Care, University of Texas and South Texas Veterans Health Care System, San Antonio, TX, USA; 3Department of Pneumology, Hôpital Cochin, AP-HP, Université Paris Descartes, Sorbonne Paris Cité, Paris, France; 4Biostatistics and Data Sciences Europe, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany; 5Respiratory Medicine, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany; 6Division of Pulmonary and Critical Care Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA Rationale: Exacerbations of COPD are managed differently, but whether treatment of one exacerbation predicts the likelihood of subsequent events is unknown. Objective: We examined whether the treatment given for exacerbations predicted subsequent outcomes. Methods: This was a post-hoc analysis of 17,135 patients with COPD from TIOtropium Safety and Performance In Respimat® (TIOSPIR®). Patients treated with tiotropium with one or more moderate to severe exacerbations on study were analyzed using descriptive statistics, logistic and Cox regression analysis, and Kaplan–Meier plots. Results: Of 8,061 patients with moderate to severe exacerbation(s), demographics were similar across patients with exacerbations treated with antibiotics and/or steroids or hospitalization. Exacerbations treated with systemic corticosteroids alone or in combination with antibiotics had the highest risk of subsequent exacerbation (HR: 1.21, P=0.0004 and HR: 1.33, P

Published
2018

2. Determinants of exacerbation risk in patients with COPD in the TIOSPIR study

Author

Calverley PMA, Tetzlaff K, Dusser D, Wise RA, Mueller A, Metzdorf N, and Anzueto A

Subjects
COPD, exacerbation, frequent exacerbators, Diseases of the respiratory system, RC705-779
Abstract

Peter MA Calverley,1 Kay Tetzlaff,2 Daniel Dusser,3 Robert A Wise,4 Achim Mueller,5 Norbert Metzdorf,2 Antonio Anzueto6 1Clinical Science Centre, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK; 2Respiratory Medicine, Boehringer Ingelheim Pharma GmbH, Ingelheim am Rhein, Germany; 3Department of Pneumology, Hôpital Cochin, Université Paris Descartes, Sorbonne Paris Cité, Paris, France; 4Division of Pulmonary and Critical Care Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA; 5Biostatistics and Data Sciences Europe, Boehringer Ingelheim Pharma GmbH, Biberach an der Riss, Germany; 6Pulmonary Medicine and Critical Care, University of Texas Health Sciences Center and South Texas Veterans’ Health Care System, San Antonio, TX, USA Background: Exacerbation history is used to grade the risk of COPD exacerbation, but its reliability and relationship to other risk factors and prior therapy is unclear. To examine these interrelationships, we conducted a post hoc analysis of patients in the TIOSPIR trial with ≥2 years’ follow-up or who died on treatment.Patients and methods: Patients were grouped by their annual exacerbation rate on treatment into nonexacerbators, infrequent, and frequent exacerbators (annual exacerbation rates 0, ≤1, and >1, respectively), and baseline characteristics discriminating among the groups were determined. We used univariate and multivariate analyses to explore the effect of baseline characteristics on risk of exacerbation, hospitalization (severe exacerbation), and death (all causes).Results: Of 13,591 patients, 6,559 (48.3%) were nonexacerbators, 4,568 (33.6%) were infrequent exacerbators, and 2,464 (18.1%) were frequent exacerbators; 45% of patients without exacerbations in the previous year exacerbated on treatment. Multivariate analysis identified baseline pulmonary maintenance medication as a predictive factor of increased exacerbation risk, with inhaled corticosteroid treatment associated with increased exacerbation risk irrespective of exacerbation history.Conclusion: Our data confirm established risk factors for exacerbation, but highlight the limitations of exacerbation history when categorizing patients and the importance of prior treatment when identifying exacerbation risk. Keywords: COPD, exacerbation, frequent exacerbators

Published
2017

4. Differences in outcomes between GOLD groups in patients with COPD in the TIOSPIR® trial

Author

Dusser D, Wise RA, Dahl R, Anzueto A, Carter K, Fowler A, and Calverley PM

Subjects
TIOSPIR, GOLD, cardiovascular comorbidity, Diseases of the respiratory system, RC705-779
Abstract

Daniel Dusser,1 Robert A Wise,2 Ronald Dahl,3 Antonio Anzueto,4,5 Kerstine Carter,6 Andy Fowler,7 Peter M Calverley8 1Service de Pneumologie, Hôpital Cochin, AP-HP, Université Paris Descartes, Sorbonne Paris Cité, Paris, France; 2Asthma and Allergy Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA; 3Allergy Centre, Odense University Hospital, Odense C, Denmark; 4Pulmonary/Critical Care, University of Texas, 5South Texas Veterans Health Care System, San Antonio, TX, USA; 6Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, USA; 7Boehringer Ingelheim Pharma Ltd, Bracknell, UK; 8Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK Background: The aim of this study was to evaluate whether Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification could predict mortality risk factors and whether baseline treatment intensity would relate to mortality within each group, using data from TIOSPIR®, the largest randomized clinical trial in COPD performed to date.Methods: A total of 17,135 patients from TIOSPIR® were pooled and grouped by GOLD grading (A–D) according to baseline Medical Research Council breathlessness score, exacerbation history, and spirometry. All-cause mortality and adjudicated cardiovascular (CV) and respiratory mortality were assessed.Results: Of the 16,326 patients classified, 1,248 died on treatment. Group B patients received proportionally more CV treatment at baseline. CV mortality risk, but not all-cause mortality risk, was significantly higher in Group B than Group C patients (CV mortality – hazard ratio [HR] =1.74, P=0.004; all-cause mortality – HR =1.18, P=0.11). Group D patients had a higher incidence of all-cause mortality than Group B patients (10.9% vs 6.6%). Similar trends were observed regardless of respiratory or CV medication at baseline. In contrast, respiratory deaths increased consistently from Groups A–D (0.3%, 0.8%, 1.6%, and 4.2% of patients, respectively).Conclusion: The data obtained from the TIOSPIR® trial, supporting earlier studies, suggest that proportionally more CV medication and CV deaths occur in GOLD Group B COPD patients, although deaths attributed to respiratory causes are more prevalent in Groups C and D. Keywords: TIOSPIR®, GOLD, cardiovascular comorbidity, mortality, respiratory death, cardiovascular death

Published
2016

42. Tiotropium Respimat Inhaler and the Risk of Death in COPD

Author

Wise RA, Anzueto A, Cotton D, Dahl R, Devins T, Disse B, Dusser D, Joseph E, Kattenbeck S, Koenen Bergmann M, Pledger G, Calverley P, for the TIOSPIR Investigators, CALABRESE, Cecilia, Wise, Ra, Anzueto, A, Cotton, D, Dahl, R, Devins, T, Disse, B, Dusser, D, Joseph, E, Kattenbeck, S, Koenen Bergmann, M, Pledger, G, Calverley, P, for the TIOSPIR, Investigator, and Calabrese, Cecilia

Abstract

Background Tiotropium delivered at a dose of 5 μg with the Respimat inhaler showed efficacy similar to that of 18 μg of tiotropium delivered with the HandiHaler inhalation device in placebo-controlled trials involving patients with chronic obstructive pulmonary disease (COPD). Although tiotropium HandiHaler was associated with reduced mortality, as compared with placebo, more deaths were reported with tiotropium Respimat than with placebo. Methods In this randomized, double-blind, parallel-group trial involving 17,135 patients with COPD, we evaluated the safety and efficacy of tiotropium Respimat at a oncedaily dose of 2.5 μg or 5 μg, as compared with tiotropium HandiHaler at a oncedaily dose of 18 μg. Primary end points were the risk of death (noninferiority study, Respimat at a dose of 5 μg or 2.5 μg vs. HandiHaler) and the risk of the first COPD exacerbation (superiority study, Respimat at a dose of 5 μg vs. HandiHaler). We also assessed cardiovascular safety, including safety in patients with stable cardiac disease. Results During a mean follow-up of 2.3 years, Respimat was noninferior to HandiHaler with respect to the risk of death (Respimat at a dose of 5 μg vs. HandiHaler: hazard ratio, 0.96; 95% confidence interval [CI], 0.84 to 1.09; Respimat at a dose of 2.5 μg vs. HandiHaler: hazard ratio, 1.00; 95% CI, 0.87 to 1.14) and not superior to HandiHaler with respect to the risk of the first exacerbation (Respimat at a dose of 5 μg vs. HandiHaler: hazard ratio, 0.98; 95% CI, 0.93 to 1.03). Causes of death and incidences of major cardiovascular adverse events were similar in the three groups. Conclusions Tiotropium Respimat at a dose of 5 μg or 2.5 μg had a safety profile and exacerbation efficacy similar to those of tiotropium HandiHaler at a dose of 18 μg in patients with COPD. (Funded by Boehringer Ingelheim; TIOSPIR ClinicalTrials.gov number, NCT01126437.)

Published
2013

44. French Intensive Care Society, International congress - Réanimation 2016

Author

Jaillette, E, Girault, C, Brunin, G, Zerimech, F, Chiche, A, Broucqsault Dedrie, C, Fayolle, C, Minacori, F, Alves, I, Barrailler, S, Robriquet, L, Delaporte, E, Thellier, D, Delcourte, C, Duhamel, A, Nseir, S, Valette, X, Desmeulles, I, Savary, B, Masson, R, Seguin, A, Daubin, C, Sauneuf, B, Verrier, P, Pottier, V, Orabona, M, Samba, D, Viquesnel, G, Lermuzeaux, M, Hazera, P, Hanouz, J, Parienti, J, Du Cheyron, D, Demoule, A, Clavel, M, Rolland Debord, C, Perbet, S, Terzi, N, Kouatchet, A, Wallet, F, Roze, H, Vargas, F, Guérin, C, Dellamonica, J, Jaber, S, Similowski, T, Quenot, J, Binquet, C, Vinsonneau, C, Barbar, S, Vinault, S, Deckert, V, Lemaire, S, Hssain, A, Bruyère, R, Souweine, B, Lagrost, L, Adrie, C, Jung, B, Daurat, A, De Jong, A, Chanques, G, Mahul, M, Monnin, M, Molinari, N, Lheureux, O, Trepo, E, Hites, M, Cotton, F, Wolff, F, Surin, R, Créteur, J, Vincent, J, Gustot, T, Jacobs, F, Taccone, F, Neuville, M, Timsit, J, El Helali, N, Le Monnier, A, Magalhaes, E, Radjou, A, Smonig, R, Soubirou, J, Voiriot, G, Sonneville, R, Bouadma, L, Mourvillier, B, Gélisse, E, Brasseur, A, Roisin, S, De Backer, D, Van Ruychevelt, V, Carlier, E, Piagnerelli, M, Vanhaeverbeek, M, Danguy, C, Biston, P, Au, S, Begot, E, Dalmay, F, Repessé, X, Prat, G, Bouferrache, K, Slama, M, Vieillard Baron, A, Monnet, X, Marik, P, Teboul, J, Jozwiak, M, Richard, C, Chauvet, J, El Dash, S, Delastre, O, Bouffandeau, B, Jusserand, D, Michot, J, Bauer, F, Brazier, F, Mercado, P, Kontar, L, Titeca, D, De Cagny, B, Bacari Risal, G, Riviere, A, Maizel, J, Guillot, C, Le Reun, C, Lampin, M, Sadik, A, Botte, A, Leteurtre, S, Collins, A, Kempeneers, C, Cajgfinger, N, Ohlmann, C, Pouyau, R, Subtil, F, Baudin, F, Massenavette, B, Javouhey, E, Milesi, C, Essouri, S, Liet, J, Afanetti, M, Durand, S, Durand, P, Roze, J, Dupont, D, Cambonie, G, Soyer, B, Rusca, M, Lukaszewicz, A, Crassard, I, Guichard, J, Bresson, D, de la Garanderie, D, Cantier, M, Sabben, C, Louedec, L, Delbosc, S, Journé, C, Ou, P, Klein, I, Chau, F, Lefort, A, Desilles, J, Michel, J, Mazighi, M, Salem, O, Demeret, S, Bolgert, F, Sharshar, T, Grabli, D, Arib, S, Crippa, I, Soummer, A, Engrand, N, Guedin, P, Aldea, S, Cerf, C, Desailly, V, Pasquier, P, Brun, P, Roux, D, Latournerie, G, Kasprzyk, L, Grosjean, V, Latreche, A, Habert, P, Huot, S, Jobin, T, Tesnière, A, Dreyfuss, D, Ricard, J, Mignon, A, Gaudry, S, Laithier, F, Kimmoun, A, Chouihed, T, Albizzati, S, Camenzind, E, Vanhuyse, F, Levy, B, Cour, M, Venet, F, Hernu, R, Demaret, J, Monneret, G, Argaud, L, Dumas, F, Lamhaut, L, Rosencher, J, Pène, F, Varenne, O, Carli, P, Jouven, X, Spaulding, C, Cariou, A, Geri, G, Bonnetain, F, Marijon, E, Empana, J, Mirouse, A, Resche Rigon, M, Mayaux, J, Rabbat, A, Meert, A, Benoit, D, Bruneel, F, Azoulay, E, Dupuis, C, Schwebel, C, Ruckly, S, Goldgran Toledano, D, Marcotte, G, Lafarge, A, Pichereau, C, Theodose, I, Scotto, M, Kemlin, D, Ghrenassia, E, Schlemmer, B, Vimpere, D, Galicier, L, Contou, D, Guérot, E, Grimaldi, D, Ricome, S, Maury, E, Plantefève, G, Dessap, A, Brun Buisson, C, de Prost, N, Dubé, B, Delemazure, J, Dres, M, Rousseau, L, Drouot, X, Diaz, V, Rebollar, Y, Frat, J, Thille, A, Aissa, D, Coquet, P, Ruiz, J, Ferre, F, Hoarau, L, Riu Poulenc, B, Bataille, B, Silva, S, Baudel, J, Bigé, N, Tahiri, J, Dubée, V, Guidet, B, Ait Oufella, H, Jinglun, L, Shen, F, Bailly, S, Leroy, O, Montravers, P, Constantin, J, Dupont, H, Guillemot, D, Lortholary, O, Perrigault, P, Gangneux, J, Razazi, K, Mekontso Dessap, A, Jansen, C, Lecronier, M, Sandrine, V, Mira, J, Blein, S, Marin, N, Rousseau, C, Charpentier, J, Pachot, A, Hraiech, S, Bordes, J, De, L, Mège, J, Forel, J, Guervilly, C, Adda, M, Raoult, D, Papazian, L, Kentish Barnes, N, Cohen Solal, Z, Souppart, V, Kerhuel, L, Haubertin, C, Exbrayat, I, Rozières, E, Argain, A, Suc, A, Vignes, M, Cougot, P, Fourcade, O, Brunel, E, Messika, J, Tubach, F, Dubief, E, Pasquet, B, Guillo, S, Pierron, C, Grimaud, M, Farnoux, C, Maillard, A, Decavèle, M, Prodanovic, H, Idbaih, A, Alentorn, A, Delattre, J, De Montmollin, E, Brule, N, Conrad, M, Dailler, F, Navellou, J, Alves, M, Tonnelier, J, Picard, G, Rogemond, V, Honnorat, J, Marzorati, C, Lebert, C, Perez, P, Citerio, G, Legriel, S, Tripon, S, Mallet, M, Rudler, M, Imbert Bismut, F, Thabut, D, Canet, E, Faguer, S, Moreau, A, Barbier, F, Merceron, S, Guitton, C, Labadie, F, Lemiale, V, Faucher, E, Klouche, K, Chevret, S, Ragot, S, Coudroy, R, Boulain, T, Jamet, A, Mercat, A, Brochard, L, Roux, A, Franchineau, G, Brechot, N, Lebreton, G, Hekimian, G, Nieszkowska, A, Leprince, P, Trouillet, J, Combes, A, Schmidt, M, Barrot, L, Piton, G, Bailey, M, Panwar, R, Belin, N, Belon, F, Patry, C, Grandperrin, M, Chaignat, C, Labro, G, Vivet, B, Capellier, G, Daix, T, Guérin, E, Tavernier, E, Mercier, E, Gissot, V, Vallejo, C, François, B, Ravry, C, Pichon, N, Chapellas, C, Fedou, A, Galy, A, Ploy, M, Barraud, O, Vignon, P, Thooft, A, Conotte, R, Colet, J, Le Dorze, M, Tarazona, V, Brumpt, C, Moins Teisserenc, H, Uhel, F, Azzaoui, I, Gregoire, M, Pangault, C, Dulong, J, Cynober, L, Roussel, M, Le Tulzo, Y, Tarte, K, Demiselle, J, Auchabie, J, Dequin, P, Chudeau, N, Fourrier, F, Grange, S, Piquilloud, L, Lautrette, A, Boyer, S, Letheulle, J, Lerolle, N, Truche, A, Clec'H, C, Zaoui, P, Laurent, V, Toledano, D, Ragey, S, Gros, A, Dumenil, A, Jamali, S, Darmon, M, Chouraqui, M, Dewitte, A, Chastel, B, Carles, P, Fleureau, C, Joannes Boyau, O, Ouattara, A, Joseph, A, Garrouste Orgeas, M, Max, A, Lerin, T, Grégoire, C, Kloeckner, M, Bruel, C, Brochon, S, Philippart, F, Pichot, E, Simons, C, Flint, A, Aubron, C, Bellomo, R, Pilcher, D, Cheng, A, Hegarty, C, Martinelli, A, Howden, B, Reade, M, Mcquilten, Z, Bretonnière, C, Villers, D, Soares, M, Gonzalez, F, Vincent, F, Fauché, C, Gay, S, Skowron, O, Levrat, A, Dorez, D, Foucrier, A, Pease, S, Gauss, T, Paugam, C, Gorham, J, Ameye, L, Paesmans, M, Berghmans, T, Sculier, J, Deras, P, Martinez, O, Latry, P, Capdevila, X, Charbit, J, Jaubert, J, Etiennar, C, Ginoux, L, Sebbah, J, Haouache, H, Dhonneur, G, Cheikh, C, Moussaid, I, Ghazaoui, O, Belkadi, K, El Youssoufi, S, Salmi, S, Pajot, L, Zuber, B, Bedos, J, Dupont, B, Eugène, A, Galateau Sallé, F, Michard, B, Lebas, B, Boivin, A, Guillot, M, Harlay, M, Janssen Langenstein, R, Schenck, M, Ellero, B, Woehl Jaegle, M, Besch, C, Castelain, V, Bachellier, P, Schneider, F, Camus, C, Saliba, F, Goubaux, B, Bonadona, A, Lavayssiere, L, Quinart, A, Barbot, O, Dharancy, S, Delafosse, B, Barraud, H, Galbois, A, Veber, B, Cayot, S, Souche, B, Locher, C, Roux, O, Figorilli, F, Putignano, A, Houssel, P, Francoz, C, Weiss, E, Agarwal, B, Jalan, R, Durand, F, Ghezala, H, Daoudi, R, Kaddour, M, Ghadhoune, H, Rachedi, E, Guissouma, J, Ben Slimene, A, Azzeza, W, Brahmi, H, Elghord, H, Kada, A, Chikh, R, Slimani, R, A. Bouyoucef, K, Regaieg, K, Kamilia, C, Baccouche, N, Turki, O, Chaari, A, Ben, H, Bouaziz, M, Medhioub, F, Zekri, M, Rgieg, K, Bhimada, C, Mounir, B, Lang, E, Welschbillig, S, Perrin, M, Devys, J, Benbernou, S, Mokhtari Djebli, H, Ilies, S, Bouyacoub, K, Azza, A, Zogheib, E, Nader, J, Villeret, L, Guilbart, M, Besserve, P, Caus, T, Mastroianni, C, Santi, F, Hékimian, G, Pascal, L, Chastre, J, Perrier, V, Deniau, B, Klasen, F, Ponthus, J, Ngasseu, P, Amilien, V, Barsam, E, Lehericey, P, Tchir, M, Georger, J, Puech, B, Vandroux, D, Roussiaux, A, Belcour, D, Ferdynus, C, Martinet, O, Jabot, J, Fresco, M, Demeilliers Pfister, G, Merle, V, Brunel, V, Dureuil, B, Leydier, S, Clerc Urmes, I, Lemarie, J, Maigrat, C, Cravoisy Popovic, A, Barraud, D, Nace, L, Gibot, S, Agrinier, N, Bollaert, P, Daban, J, Boutonnet, M, Dumas, G, Falzone, E, Jault, P, Lenoir, B, Makunza, J, Mejeni, N, Mazaud, A, Béague, S, Rousselle, A, Durocher, A, Grinea, A, Bedoui, N, Stoian, A, Baboi, L, Gobert, F, Yonis, H, Tapponier, R, Bruyneel, A, Bonus, T, Cuvelier, G, Machayeckhi, S, Olieuz, S, Legrand, A, Feki, F, Jamoussi, A, Merhebene, T, Braham, E, Ghariani, A, Mezni, F, Slim, L, Khelil, J, Besbes, M, Marchalot, A, Beduneau, G, Carpentier, D, Besnier, E, Gastaldi, G, Abily, J, Beuzelin, M, Nay, M, Mankikian, J, Hervé, V, Soulie, M, Cronier, P, Kantor, E, Federici, L, Gilbert, M, Mezhari, I, Choukroun, G, Marque, S, Coppere, Z, Fulgencio, J, Blayau, C, Pham, T, Djibre, M, Reffienna, M, Lefort, S, Debue, A, Daviaud, F, Cabon, S, Addou, Z, Douah, A, Moussati, M, Belhabiche, K, Aouffen, N, Soulier, S, Mauriat, P, Tafer, N, Mortamet, G, Amaddeo, A, Khirani, S, Fauroux, B, Khanes, G, Liutko, O, Bidnenko, S, Doye, E, Voirin, N, Maucort Boulch, D, Kolev Descamp, K, Aouane, I, Essid, A, Hammami, W, Haegy, I, Bataille, J, Bergounioux, J, Morin, L, Ray, S, Maclaren, G, Nadel, S, Kneyber, M, Peters, M, Jansen, K, De Luca, D, Wilson, C, Schlapbach, L, Tissières, P, Girard, A, Savajols, E, Burguet, A, Semama, D, Litzler Renault, S, Fredj, H, Hassouna, M, Hechmi, Y, Cherif, M, Zouheir, J, Dernane, A, Bouakkaz, F, Taleb, L, Zeddine Mouhsen, A, Lyazidi, A, Richard, J, Mouhsen, A, Harmouchi, M, Rattal, M, Huck, M, Leclerc, T, Donat, N, Cirodde, A, Schaal, J, Masson, Y, Hoffmann, C, Cerland, L, Valentino, R, Chabartier, C, Villain Coquet, L, Ferge, J, Brouste, Y, Mehdaoui, H, Louriz, M, Madani, N, Amlaiky, F, Dendane, T, Abidi, K, Zekraoui, A, Zeggwagh, A, Abouqal, R, Brahim, A, Ferhi, F, Bouslama, M, Benjazia, K, Zeineb, A, Mahassen, D, Cadiet, J, Ferron, M, Prat, V, Erraud, A, Aillerie, V, Mevel, M, Grabherr, A, Chatham, J, Gauthier, C, Lauzier, B, Rozec, B, Joffre, J, Loyer, X, Lavillegrand, J, Zeboudj, L, Laurans, L, Esposito, B, Tedgui, A, Mallat, Z, Wei, C, Kattani, N, Louis, H, Orlowski, S, Tharaux, P, Burban, M, Meyer, G, Olland, A, Yver, B, Toti, F, Schini Kerth, V, Monnier, A, Leborgne, P, Meziani, F, Clavier, T, Paulus, M, Castel, H, Richard, V, Pons, S, Skurnik, D, Six, S, Jaffal, K, 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Seghboyan, J, Gamblin, C, Benturquia, N, Roussel, O, Chevillard, L, Risede, P, Callebert, J, Khelfa, M, Blel, Y, Thabet, H, Brahmi, N, Amamou, M, Le Louët, A, Baud, F, Le Beller, C, Vivien, B, Soufir, L, Le Louët, H, Essafi, F, Foudhaili, N, Slimen, A, Jabla, R, Hammed, H, Marzouk, M, Boujelbene, N, Dachraoui, F, Hachani, A, Abdallah, S, Lakhal, H, Ghribi, C, Ali, I, Abdellaoui, I, Ouanes Besbes, L, Abroug, F, Demiri, S, Lorut, C, Van Lang, D, Lefebvre, A, Alifano, M, Reignard, J, Samama, M, Dusser, D, Roche, N, Réminiac, F, Landel, C, Gensburger, S, Bocar, T, Mordier, L, Philippe, M, Le Pennec, D, Vecellio, L, Ehrmann, S, Poiroux, L, Thevoz, D, Simons, J, Roeseler, J, Loiez, A, Gérard, S, Dousse, N, L'Hotellier, S, Baumgarten, E, Borschneck, S, Kharcha, F, Ghander, C, Tresallet, C, Puymirat, E, Fagon, J, Aegerter, P, Diehl, J, Hauw Berlemont, C, Chatellier, G, Danchin, N, Aissaoui, N, Aissat, N, Bernard, R, Amour, J, Bouglé, A, Vidal, C, Nima, D, Shaida, V, Dorget, A, Bréchot, N, 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Elkhawand, C, Vermeesh, F, Vermeesh, F., and CITERIO, GIUSEPPE

Abstract

Determinants of outcome in critically ill patients with hematological malignancy and central neurological failure: data from the TRIAL OH study

Published
2016

45. Testing Two Different Doses of Tiotropium Respimat® in Cystic Fibrosis: Phase 2 Randomized Trial Results

Author

Bradley, Jm, Koker, P, Deng, Q, Moroni Zentgraf, P, Ratjen, F, Geller, De, Elborn, Js, Clements, B, Greville, H, Middleton, P, Serisier, D, van Asperen, P, Dupont, L, Knoop, C, Malfroot, A, Belleguic, C, Chiron, R, Derelle, J, Dominique, S, Dusser, D, Ginies, Jl, Guillot, M, Horeau-Langlard, D, Le Bourgeois, M, Leroy, S, Marguet, C, Munck, A, Pautard, Jc, Reix, P, Uffredi, Ml, Ballmann, M, Bargon, J, Fischer, R, Herth, F, Heuer, He, Griese, M, Kamin, W, Kohlhäufl, M, Nährlich, L, Riethmüller, J, Sorichter, S, Wagner, T, Bennett, L, Crawford, M, Crossley, J, Derry, D, Doull, I, Elborn, J, Everard, M, Groggins, C, Johnson, M, Lee, T, Rayner, R, Reid, A, Smyth, A, Southern, K, Thomas, D, Walshaw, M, Whitehouse, J, Braggion, C, De Rose, V, Gagliardini, R, Minicucci, L, Reijers, M, Tiddens, Ha, O'Carroll, M, Wong, J, Barreto, C, Cardim, P, Loureiro, M, Rocha, H, Vaz, Ml, Asherova, I, Chepurnaya, M, Chuchalin, Ag, Ilkovich, M, Kapranov, N, Neretina, A, Orlov, A, Simonova, O, Ahrens, R, Anbar, R, Biller, J, Carveth, H, Daines, C, Fiel, S, Flume, P, Froh, D, 3rd, Harris J., Howenstine, M, Millard, Dl, Nasr, S, Parker, H, Pian, M, Royall, J, Sabogal, C, Salathe, M, Sannuti, A, Schaeffer, D, Strausbaugh, S, Toder, D, Reyes, S, Whittaker, L, and Zanni, R.

Subjects
Male, Respimat, Cystic Fibrosis, Pulmonology, lcsh:Medicine, Cystic fibrosis, Pediatrics, Pulmonary function testing, law.invention, Clinical trials, Randomized controlled trial, law, Bronchodilator, Forced Expiratory Volume, lcsh:Science, Child, Medicine(all), Multidisciplinary, Agricultural and Biological Sciences(all), Area under the curve, Tiotropium bromide, Respiratory Function Tests, Research Design, Anesthesia, Female, Genetic Dominance, Phase II clinical investigation, medicine.drug, Research Article, Adult, medicine.medical_specialty, Adolescent, General Science & Technology, medicine.drug_class, Clinical Research Design, Pediatric Pulmonology, Scopolamine Derivatives, Placebo, Research and Analysis Methods, Young Adult, Double-Blind Method, MD Multidisciplinary, Administration, Inhalation, medicine, Genetics, Humans, Tiotropium Bromide, Medicine and health sciences, Autosomal Recessive Traits, business.industry, Biochemistry, Genetics and Molecular Biology(all), lcsh:R, Biology and Life Sciences, Human Genetics, medicine.disease, Fibrosis, respiratory tract diseases, Clinical medicine, Physical therapy, Tiotropium Cystic Fibrosis Study Group, lcsh:Q, business, Developmental Biology
Abstract

Background Tiotropium is a once-daily, long-acting anticholinergic bronchodilator with the potential to alleviate airway obstruction in cystic fibrosis. Our objective was to evaluate the efficacy and safety of 2.5 and 5 µg once-daily tiotropium delivered via the Respimat Soft Mist Inhaler vs. placebo in people with cystic fibrosis. Methods This phase 2, 12-week, randomized, double-blind, placebo-controlled parallel-group study of tiotropium Respimat as add-on to usual cystic fibrosis maintenance therapy included people with cystic fibrosis with pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥25% predicted. Co-primary efficacy end points were change from baseline in percent-predicted FEV1 area under the curve from 0 to 4 hours (FEV1 AUC0–4h), and trough FEV1 at the end of week 12. Findings A total of 510 subjects with cystic fibrosis aged 5–69 years were randomized. Both doses of tiotropium resulted in significant improvement compared with placebo in the co-primary efficacy end points at the end of week 12 (change from baseline in percent-predicted FEV1 AUC0–4h: 2.5 µg: 2.94%, 95% confidence interval 1.19–4.70, p = 0.001; 5 µg: 3.39%, 95% confidence interval 1.67–5.12, p = 0.0001; in percent-predicted trough FEV1∶2.5 µg: 2.24%, p = 0.2; 5 µg: 2.22%, p = 0.02). There was a greater benefit with tiotropium 5 vs. 2.5 µg. No treatment-related adverse events or unexpected safety findings were observed in patients taking tiotropium. Conclusions Tiotropium significantly improved lung function in people with cystic fibrosis. The improvement was greater with the higher dose than the lower dose, with no difference in adverse events. Trial Registration ClinicalTrials.gov NCT00737100 EudraCT 2008-001156-43.

Published
2014
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