A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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This study evaluated the effect of inhaled aclidinium bromide on exercise endurance and in reducing resting and dynamic lung hyperinflation in patients with moderate to severe COPD. It was 9 weeks in duration, consisting of; a 2-week run-in period, 6 weeks of double-blind treatment, and a 1-week follow-up phone call. All patients meeting the eligibility criteria were randomized to one of two treatment groups: aclidinium bromide or placebo.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Clinical Study to Assess the Effect of Inhaled Aclidinium Bromide (LAS34273) 200 ug on Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe COPD

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Aclidinium Bromide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of stable moderate to severe COPD (GOLD 2006); post-levalbuterol FEV1 >=30% and < 80% predicted and FEV1/FVC<70% predicted Current or former cigarette smoker Functional Residual Capacity (FRC) measured by body plethysmography >= 120% of predicted value Baseline Dyspnea Index (BDI) focal score ≤ 7 at Visit 4 Exclusion Criteria: History of presence of asthma, allergic rhinitis, or atopy Hospitalization for acute COPD exacerbation in the 3 months prior to study entry Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry Clinically significant respiratory conditions other than COPD Chronic use of oxygen therapy >= 15 hours a day

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aclidinium<br> | Drug: Aclidinium Bromide<br>* Aclidinium Bromide, 200μg. Once daily oral inhalation.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Dose matched placebo, once daily oral inhalation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Exercise Endurance Time (ET) | Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds. | From baseline Week 0 (Visit 4) to Week 6 (Visit 6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough Forced Expiratory Volume in 1 Second (FEV1) | Change in trough Forced Expiratory Volume in 1 second. FEV1 was assessed at the end of the daily dosing interval (Trough). | Change from baseline (Visit 4) at Week 6 (Visit 6) | 
| Trough Inspiratory Capacity (IC) | Change in trough Inspiratory Capacity. Inspiratory Capacity was measured as part of the spirometry procedures performed at each visit. IC was assessed at the end of the daily dosing interval (Trough). | Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) | 
| Functional Residual Capacity (FRC) | Change in trough Functional Residual Capacity. FRC was assessed at the end of the daily dosing interval (Trough). | Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) | 
| Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio | Ratio of trough Inspiratory Capacity verses Total Lung Capacity. | Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchitis, Chronic; Emphysema