The Spirometric Efficacy of Once-Daily Dosing With Tiotropium in Stable COPD

Autor: Charles W. Serby, Theodore J. Witek, Richard Casaburi, Dick D. Briggs, James F. Donohue, Shailendra Menjoge
Rok vydání: 2000
Předmět:
Zdroj: Chest. 118:1294-1302
ISSN: 0012-3692
DOI: 10.1378/chest.118.5.1294
Popis: Study objective To compare the bronchodilator efficacyand safety of tiotropium and placebo. Design A3-month, randomized, double-blind, placebo-controlled, multicentertrial. Setting Outpatient. Patients Four hundred seventy patients with stable COPD (meanFEV 1 = 38.6% predicted). Interventions Tiotropium 18 μg (N = 279) or placebo (N = 191) given once dailyvia a lactose-based dry-powder inhaler device. Measurementsand results Spirometry was evaluated on days 1, 8, 50, and 92.Data were expressed as the mean trough ( ie , beforemorning dose; 23 to 24 h after previous dose) and average responseobserved in the 3 h after the dose was received. Tiotropiumproduced significant improvement in trough FEV 1 and FVC,averaging 12% greater than baseline on day 8; these improvements weremaintained on days 50 and 92. The average postdose FEV 1 was16% greater than baseline on day 1 and 20% greater than baseline onday 92; FVC was 17% greater than baseline on day 1 and 19% greaterthan baseline on day 92. Tiotropium was significantly more effectivethan placebo in both trough and average FEV 1 and FVCresponse (p Conclusions These data demonstrate that tiotropium is asafe and effective once-daily anticholinergic bronchodilator and shouldprove useful as first-line maintenance therapy inCOPD.
Databáze: OpenAIRE