title: Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler versus MDI.
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].
authors.affiliation: St. Francis Hospital Medical Center, Hartford, CT 06105, USA. rzuwalla@stfranciscare.org
authors.forename: R
authors.initials: R
authors.lastname: Zuwallack
authors.forename: M C
authors.initials: MC
authors.lastname: De Salvo
authors.forename: T
authors.initials: T
authors.lastname: Kaelin
authors.forename: E D
authors.initials: ED
authors.lastname: Bateman
authors.forename: C S
authors.initials: CS
authors.lastname: Park
authors.forename: R
authors.initials: R
authors.lastname: Abrahams
authors.forename: F
authors.initials: F
authors.lastname: Fakih
authors.forename: P
authors.initials: P
authors.lastname: Sachs
authors.forename: K
authors.initials: K
authors.lastname: Pudi
authors.forename: Y
authors.initials: Y
authors.lastname: Zhao
authors.forename: C C
authors.initials: CC
authors.lastname: Wood
mesh_terms: D000280:Administration, Inhalation; D000420:Albuterol / Q000008:administration & dosage*; D000068600:Albuterol, Ipratropium Drug Combination; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects / Q000502:physiology; D006801:Humans; D009241:Ipratropium / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D012129:Respiratory Function Tests / Q000379:methods; D016896:Treatment Outcome
chemical_list: D000068600:Albuterol, Ipratropium Drug Combination; D001993:Bronchodilator Agents; D009241:Ipratropium; D000420:Albuterol