A Randomised, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Parallel Group Efficacy and Safety Comparison of 12-Week Treatment 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, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Boehringer Ingelheim28 sites in 4 countries429 target enrollmentNovember 2002

ConditionsPulmonary Disease, Chronic Obstructive

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Enrollment: 429
Locations: 28
Primary Endpoint: Trough FEV1 response
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.

Registry

clinicaltrials.gov

Start Date

November 2002

End Date

December 2003

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Trough FEV1 response

Time Frame: after 12 weeks

Secondary Outcomes

Trough FEV1 response(after 1, 4 and 8 weeks)
Trough FVC response(after 1, 4, 8 and 12 weeks)
FEV1 and FVC area under the curve (AUC)0-6h and peak response(after 0, 1, 4, 8 and 12 weeks)
Individual FEV1 and FVC measurements(during 12 weeks)
Onset and duration of therapeutic response and percentage of responders(after 0 and 12 weeks)
Weekly mean pre-dose morning and evening PEFR (peak expiratory flow rate)(up to 12 weeks)
Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol)(up to 12 weeks)
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)(up to 15 weeks)
Physician's Global Evaluation(up to 15 weeks)
Number of patients with at least one exacerbation of COPD(up to 15 weeks)
Time to first exacerbation(up to 15 weeks)
Number of exacerbations and exacerbation days(up to 15 weeks)