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

SummaryWe 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 (20/100 mcg) Respimat® inhaler, ipratropium bromide/albuterol MDI [36 mcg/206 mcg (Combivent® Inhalation Aerosol MDI)], or ipratropium bromide (20 mcg) Respimat® inhaler. Each medication was administered four times daily. Serial spirometry was performed over 6 h (0.15 min, then hourly) on 4 test days. The primary efficacy variable was forced expiratory volume in 1 s (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 0–6 h (AUC0–6), superior efficacy to ipratropium Respimat® inhaler for FEV1 AUC0–4 and comparable efficacy to ipratropium Respimat® inhaler for FEV1 AUC4–6. All active treatments were well tolerated.This study demonstrates that ipratropium bromide/albuterol 20/100 mcg inhaler® administered four times daily for 12 weeks had equivalent bronchodilator efficacy and comparable safety to ipratropium bromide/albuterol 36 mcg/206 mcg MDI, and significantly improved lung function compared with the mono-component ipratropium bromide 20 mcg Respimat® inhaler. [Clinical Trial Identifier Number: NCT00400153]