Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment period and a 2-week follow up phone call. All patients will be randomized to one of two doses of aclidinium bromide.

Official Title
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A Long-Term, Randomized, Double-Blind Study of the Safety, Tolerability and Efficacy of Aclidinium Bromide At Two Dosage Levels When Administered to Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Aclidinium Bromide 200 µg
* Drug: Aclidinium Bromide 400 µg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2010; postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 ≥ 30% and < 80% predicted Current or former cigarette smokers Exclusion Criteria: Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1 Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness History or presence of asthma verified from medical records Chronic use of oxygen therapy greater than or equal to 15 hours per day Patient with uncontrolled infection due to HIV and/or active hepatitis Patients with a history of hypersensitivity reaction to inhaled anticholinergics Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aclidinium Bromide 200 µg<br>aclidinium bromide, inhaled, 52 weeks of treatment | Drug: Aclidinium Bromide 200 µg<br>* aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment<br>|
| Experimental: Aclidinium Bromide 400 µg<br>aclidinium bromide, inhaled, 52 weeks of treatment | Drug: Aclidinium Bromide 400 µg<br>* aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) | Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52. | From baseline to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Peak FEV1 | Change From Baseline in Peak FEV1 in liters at Week 52. | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Emphysema, Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease