High Dose Trial in COPD

Study Overview
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Brief Summary
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The primary objective of this study was to compare the efficacy and safety of 200 μg and 400 μg of BEA 2180 BR to tiotropium 5 μg and placebo when each was delivered by the Respimat® Inhaler once daily for four weeks in patients with COPD.

Official Title
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A Randomized, Multiple-dose, Double-Blind, Crossover Study to Compare the Efficacy and Safety of 200 μg and 400 μg of BEA 2180 BR to Tiotropium 5 μg and Placebo When Each is Delivered by the Respimat® Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: BEA 2180 BR
* Drug: tiotropium


Participation Criteria
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Eligibility Criteria
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Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 >=30% and <= 60% of predicted normal and FEV1 <=70% of FVC at the baseline PFTs at Visit 1 (at both timepoints). All patients must have an increase in FEV1 of at least 12% from baseline (th e -10 minute measurement) 45 min after inhalation of 80 ?g Atrovent MDI. Male or female patients 40 years of age or older. Smoker or ex-smoker with a history of more than 10 pack years. 1. Patients with any other significant disease will be excluded. 2. Patients with a history of asthma or allergic rhinitis will be excluded.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 84 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: BEA 2180 BR|nan|
|Drug: tiotropium|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough forced expiratory volume (FEV1) response |  | baseline to 24 hours post drug administration | 
| forced expiratory volume in one second (FEV1) area under curve 3 to 6 hours (AUC0-6h) after four weeks of treatment. |  | after 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough FVC response after 4 weeks |  | after 4 weeks | 
| FEV1 and FVC peak response after 0 and 4 weeks |  | after 0 and 4 weeks | 
| FVC AUC0-6h after 0 and 4 weeks |  | after 0 and 4 weeks | 
| Individual FEV1 and FVC measurements at each time point |  | 4 weeks | 
| Weekly mean pre-dose morning and evening PEFR |  | 4 weeks | 
| Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol] |  | 4 weeks | 
| COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest |  | 4 weeks | 
| Physician's Global Evaluation |  | 4 weeks | 
| All adverse events |  | 28 weeks | 
| Pulse rate and blood pressure (seated) recorded in conjunction with spirometry for the first three hours following dosing |  | 28 weeks | 
| 12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose on Day 1 and 29 of each treatment period (Visits 2-9) |  | 28 weeks |