Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat® inhaler versus MDI

ZuWallack, R.; De Salvo, M.C.; Kaelin, T.; Bateman, E.D.; Park, C.S.; Abrahams, R.; Fakih, F.; Sachs, P.; Pudi, K.; Zhao, Y.; Wood, C.C.; on behalf of the Combivent Respimat® inhaler Study Group,

doi:10.1016/j.rmed.2010.01.017

« Previous Next »Respiratory Medicine
Volume 104, Issue 8 , Pages 1179-1188, August 2010

Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat^® inhaler versus MDI

R. ZuWallack
- St. Francis Hospital Medical Center, Hartford, CT 06105, USA
- Corresponding author. Tel.: +1 860 714 4045.
M.C. De Salvo
- Centro Medico Dra. de Salvo, Buenos Aires, Argentina
T. Kaelin
- Lowcountry Lung Critical Care, Charleston, SC 29406, USA
E.D. Bateman
- Dept of Medicine, University of Cape Town, Cape Town 7937, South Africa
C.S. Park
- Soonchunhyang University Hospital Bucheon, Bucheon-Si 420-021, Korea
R. Abrahams
- Morgantown Pulmonary Clinical Research, Morgantown, WV 26505, USA
F. Fakih
- Florida Pulmonary Research Center, Winter Park, FL 32789, USA
P. Sachs
- Pulmonary Associates of Stamford, Stamford, CT 06902, USA
K. Pudi
- Upstate Pharmaceutical Research, Greenville, SC 29615, USA
Y. Zhao
- Boehringer Ingelheim Pharmaceutical, Inc, Ridgefield, CT 06877, USA
C.C. Wood
- Boehringer Ingelheim Pharmaceutical, Inc, Ridgefield, CT 06877, USA
on behalf of the Combivent Respimat^® inhaler Study Group

Received 4 November 2009; accepted 23 January 2010. published online 22 February 2010.

Summary

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 (FEV₁) 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 FEV₁ (percent predicted) of 41%. Ipratropium bromide/albuterol Respimat^® inhaler had comparable efficacy to ipratropium bromide/albuterol MDI for FEV₁ area under the curve at 0–6h (AUC_0–6), superior efficacy to ipratropium Respimat^® inhaler for FEV₁ AUC_0–4 and comparable efficacy to ipratropium Respimat^® inhaler for FEV₁ 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]

Keywords: COPD, Respimat^® inhaler, Ipratropium bromide, Anticholinergic, Bronchodilator