12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler
* Device: 10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler


Participation Criteria
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Eligibility Criteria
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Outpatients of either sex, aged >/= 40 years with a diagnosis of COPD (FEV1 </= 60% predicted [ECCS criteria] and FEV1/FVC </= 70%)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler|nan|
|Device: 10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough FEV1 response after 12 weeks of treatment. |  | after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| 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 | 
| COPD symptom scores |  | during 15 weeks | 
| Physician's Global Evaluation |  | during 15 weeks | 
| Number of patients with at least one exacerbation of COPD |  | 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 | 
| 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 |