A Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison of 12-week Treatment of Two Doses (5 Mcg and 10 Mcg) of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) i

Boehringer Ingelheim11 sites in 2 countries491 target enrollmentNovember 2002

ConditionsPulmonary Disease, Chronic Obstructive

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Enrollment: 491
Locations: 11
Primary Endpoint: Trough FEV1 response after 12 weeks of treatment.
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 after 12 weeks of treatment.

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)
Therapeutic response and percentage of responders(after 0 and 12 weeks)
Weekly mean pre-dose morning and evening PEFR(during study course of 12 weeks)
Number of occasions of rescue therapy used per day (PRN salbutamol)(during study course of 12 weeks)
Physician's Global Evaluation(during 15 weeks)
time to first exacerbation(15 weeks)
number of exacerbations(15 weeks)
number of exacerbation days(15 weeks)
Patient satisfaction and preference(12 weeks)
FEV1 and FVC area under the curve and peak response(after 0, 1, 4, 8 and 12 weeks)
Individual FEV1 and FVC measurements at each time point(during study course of 12 weeks)
Number of patients with at least one exacerbation of COPD(15 weeks)
COPD symptom scores(during 15 weeks)
All adverse events(during 15 weeks, follow-up period included)
Pulse rate and blood pressure for the first three hours following dosing(after 0, 1, 4, 8 and 12 weeks)
Routine blood chemistry, haematology and urinalysis(after 12 weeks)
12-lead ECG(after 12 weeks)
Physical examination(after 12 weeks)