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

• Published in: Respiratory medicine Vol. 104; no. 8; pp. 1179 - 1188
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 01.08.2010; Elsevier; Elsevier Limited
• Subjects: Administration, Inhalation; Albuterol - administration & dosage; Albuterol, Ipratropium Drug Combination; Anticholinergic; Biological and medical sciences; Bronchodilator; Bronchodilator Agents - administration & dosage; Chronic obstructive pulmonary disease, asthma; COPD; Double-Blind Method; Female; Forced Expiratory Volume - drug effects; Forced Expiratory Volume - physiology; Humans; Ipratropium - administration & dosage; Ipratropium bromide; Male; Medical sciences; Middle Aged; Nebulizers and Vaporizers; Pneumology; Pulmonary Disease, Chronic Obstructive - drug therapy; Pulmonary Disease, Chronic Obstructive - physiopathology; Pulmonary/Respiratory; Respimat ® inhaler; Respiratory Function Tests - methods; Treatment Outcome; Respimat ® inhaler; Anticholinergic; Ipratropium bromide; Bronchodilator; COPD; Lung disease; Respiratory disease; Respimat; Chronic; Efficiency; Inhaler; Bronchus disease; Chronic obstructive pulmonary disease; Salbutamol; Obstructive pulmonary disease; Safety; Comparative study; Pneumology
• ISSN: 0954-6111; 1532-3064
• DOI: 10.1016/j.rmed.2010.01.017

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 (20/100 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]