Efficacy and Safety Comparison of 4-week Treatment Periods of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Tiotropium Inhalation Powder Capsule (18μg) Delivered by the HandiHaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Boehringer Ingelheim9 sites in 2 countries131 target enrollmentNovember 26, 2002

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Enrollment: 131
Locations: 9
Primary Endpoint: Trough FEV1 response determined at the end of each 4-week period of randomised treatment.
Status: Completed
Last Updated: 2 years ago

Non-inferiority of lung function response to Tiotropium inhalation solution compared to Spiriva HandiHaler

Registry

clinicaltrials.gov

Start Date

November 26, 2002

End Date

April 29, 2004

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Sponsor

Responsible Party

Sponsor

Trough FEV1 response determined at the end of each 4-week period of randomised treatment.

Time Frame: at the end of each 4-week period

FEV1 AUC 0-12h and FVC AUC 0-12h response(after 4 weeks)
Individual FEV1and FVC measurements(during study course of 28 weeks)
FEV1 AUC 0-3h and FVC AUC 0-3h response(after the first dose, after 4 weeks)
Tiotropium plasma concentration data and urinary excretion data(at the end of each 4-week period)
Trough forced vital capacity (FVC) response(after 4 weeks)
Peak response (FEV1 and FVC)(within 3 hours after first dose, after 4 weeks)
pre-dose morning and evening peak expiratory flow rate (PEFR)(during study course of 28 weeks)
Number of occasions of rescue therapy used(during study course of 28 weeks)
Median time to onset of therapeutic response after first dose (FEV1)(after first dose and after 4 weeks)
Number of patients with 15% response above baseline for each treatment at each time point after first dose and after 4 weeks(up to 28 weeks)