Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler versus MDI
R Zuwallack, M C De Salvo, T Kaelin, E D Bateman, C S Park, R Abrahams, F Fakih, P Sachs, K Pudi, Y Zhao, C C Wood, Combivent Respimat Inhaler Study Group, R Gené, G Di Bartolo, P Kaplan, A Echazarreta, L Larreateguy, X Bocca, G Welker, A Rodríguez, E De Vito, R Del Olmo, S Nahabedian, R Rojas, C Elias, H Defranchi, H Pegliasco, B Bernard, F Fortin, J Y Jasnot, C Verkindre, D Singh, E Chilvers, R West, E Evans, T Howes, T K Rogers, A Gunstone, J Langan, R Russell, G Tatsis, K Gourgoulianis, N Galanis, G Patlakas, N Siafakas, E Zervas, H Bitsakou, M Gaga, A Vetoulis, J H Yoo, J J Shim, S T Uh, J Chang, S J Yong, L Kwan Ho, K Kwan Hyoung, P Black, G Mills, D R Taylor, D Quinn, J Gillies, P Sliwinski, W Skucha, E Pisarczyk-Bogacka, B Asankowicz-Bargiel, H Batura-Gabryel, A Prokop-Staszecka, P Nalepa, M Czajkowska, W Szanfranski, M J Mierzejerska, E I Shmelev, L A Goryachkina, A G Chuchalin, V Nonikov, V Ignatiev, M Ilkovich, S Sobchenko, A Vizel, J R Joubert, W Mans, J A O'Brien, C Smith, M Greenblatt, D Bernhardi, A Pieterse, H P Kuo, F J Chen, P H Kuo, Y C Liu, J Y Hsu, S Saryal, S Atis, S Karakurt, A Cilli, V Yilmaz, L Yashyna, V Gavrysyuk, L Shvayko, L Konopkina, N Y Monogarova, T Amgott, C P Andrews, P Arcuri, S Basheda, T Bruya, J A Cooper, C Cote, H Covelli, M Godschalk, L Dunn, C Fogarty, A Gelb, G M Giessel, N Hanania, J Karpel, E Kerwin, C Laforce, R Lapidus, D Lawlor, M Littner, A I Patel, M Mandel, T Moriarty, A Razzetti, S Sahn, I Spirn, R Sussman, D Tashkin, J Taylor, J Tita, D Webster, A Heller, J Winder, R Wise, C Corder, B Levine, B Make, E Bleecker, W G Kuschner, P Halverson, W Stringer, L Lynn, P Krumpe, D Kukafka, J Westerman, S Kimura, R Gaona, W Summer, T Martin, J Liu, W Beliveau, D Lorch, C A Henry, S Weaver, L Repsher, D Elkayam, J Lochner, D Amin, J Hansbrough, T Craig, E Eden, M Conway, P F Bass 3rd, A Seibert, G Walker, D Hagaman, R Light, P Korenblat, P Boyce, W McCann, M Lindley, S Newman, J V Meli, C Wu, P Snell, A Koser, R Gilman, D Hill, G I Greenwald, R Fei, R Zuwallack, M C De Salvo, T Kaelin, E D Bateman, C S Park, R Abrahams, F Fakih, P Sachs, K Pudi, Y Zhao, C C Wood, Combivent Respimat Inhaler Study Group, R Gené, G Di Bartolo, P Kaplan, A Echazarreta, L Larreateguy, X Bocca, G Welker, A Rodríguez, E De Vito, R Del Olmo, S Nahabedian, R Rojas, C Elias, H Defranchi, H Pegliasco, B Bernard, F Fortin, J Y Jasnot, C Verkindre, D Singh, E Chilvers, R West, E Evans, T Howes, T K Rogers, A Gunstone, J Langan, R Russell, G Tatsis, K Gourgoulianis, N Galanis, G Patlakas, N Siafakas, E Zervas, H Bitsakou, M Gaga, A Vetoulis, J H Yoo, J J Shim, S T Uh, J Chang, S J Yong, L Kwan Ho, K Kwan Hyoung, P Black, G Mills, D R Taylor, D Quinn, J Gillies, P Sliwinski, W Skucha, E Pisarczyk-Bogacka, B Asankowicz-Bargiel, H Batura-Gabryel, A Prokop-Staszecka, P Nalepa, M Czajkowska, W Szanfranski, M J Mierzejerska, E I Shmelev, L A Goryachkina, A G Chuchalin, V Nonikov, V Ignatiev, M Ilkovich, S Sobchenko, A Vizel, J R Joubert, W Mans, J A O'Brien, C Smith, M Greenblatt, D Bernhardi, A Pieterse, H P Kuo, F J Chen, P H Kuo, Y C Liu, J Y Hsu, S Saryal, S Atis, S Karakurt, A Cilli, V Yilmaz, L Yashyna, V Gavrysyuk, L Shvayko, L Konopkina, N Y Monogarova, T Amgott, C P Andrews, P Arcuri, S Basheda, T Bruya, J A Cooper, C Cote, H Covelli, M Godschalk, L Dunn, C Fogarty, A Gelb, G M Giessel, N Hanania, J Karpel, E Kerwin, C Laforce, R Lapidus, D Lawlor, M Littner, A I Patel, M Mandel, T Moriarty, A Razzetti, S Sahn, I Spirn, R Sussman, D Tashkin, J Taylor, J Tita, D Webster, A Heller, J Winder, R Wise, C Corder, B Levine, B Make, E Bleecker, W G Kuschner, P Halverson, W Stringer, L Lynn, P Krumpe, D Kukafka, J Westerman, S Kimura, R Gaona, W Summer, T Martin, J Liu, W Beliveau, D Lorch, C A Henry, S Weaver, L Repsher, D Elkayam, J Lochner, D Amin, J Hansbrough, T Craig, E Eden, M Conway, P F Bass 3rd, A Seibert, G Walker, D Hagaman, R Light, P Korenblat, P Boyce, W McCann, M Lindley, S Newman, J V Meli, C Wu, P Snell, A Koser, R Gilman, D Hill, G I Greenwald, R Fei
Abstract
We compared the efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler, a novel propellant-free inhaler, versus chlorofluorocarbon (CFC)-metered dose inhaler (MDI) and ipratropium Respimat inhaler in patients with COPD. This was a multinational, randomized, double-blind, double-dummy, 12-week, parallel-group, active-controlled study. Patients with moderate to severe COPD were randomized to ipratropium bromide/albuterol (20/100mcg) Respimat inhaler, ipratropium bromide/albuterol MDI [36mcg/206mcg (Combivent Inhalation Aerosol MDI)], or ipratropium bromide (20mcg) Respimat inhaler. Each medication was administered four times daily. Serial spirometry was performed over 6h (0.15min, then hourly) on 4 test days. The primary efficacy variable was forced expiratory volume in 1s (FEV(1)) change from test day baseline at 12 weeks. A total of 1209 of 1480 randomized, treated patients completed the study; the majority were male (65%) with a mean age of 64 yrs and a mean screening pre-bronchodilator FEV(1) (percent predicted) of 41%. Ipratropium bromide/albuterol Respimat inhaler had comparable efficacy to ipratropium bromide/albuterol MDI for FEV(1) area under the curve at 0-6h (AUC(0-6)), superior efficacy to ipratropium Respimat inhaler for FEV(1) AUC(0-4) and comparable efficacy to ipratropium Respimat inhaler for FEV(1) AUC(4-6). All active treatments were well tolerated. This study demonstrates that ipratropium bromide/albuterol 20/100mcg inhaler administered four times daily for 12 weeks had equivalent bronchodilator efficacy and comparable safety to ipratropium bromide/albuterol 36mcg/206mcg MDI, and significantly improved lung function compared with the mono-component ipratropium bromide 20 mcg Respimat inhaler. [Clinical Trial Identifier Number: NCT00400153].
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Source: PubMed