Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in period followed by a 12-week double-blind, placebo-controlled treatment period. This will be followed by an open-label 40-week treatment period and a 2-week follow up phone call. All patients will receive the higher Aclidinium Bromide during the 40-week open label treatment period.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of 2 Doses of Aclidinium Bromide Compared With Placebo for 12 Weeks in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease Followed by a 40-Week Evaluation of the Higher Aclidinium Bromide Dose

Conditions
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Chronic Obstructive Pulmonary Disease

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 as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2008; 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: 1<br>Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks | Drug: Aclidinium bromide<br>* Aclidinium bromide 200 μg, oral inhalation twice per day 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks of treatment.<br>|
| Experimental: 2<br>Aclidinium bromide 400 μg dose twice per day, inhaled for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg will continue to receive open label 400µg aclidinium bromide for 40 weeks | Drug: Aclidinium bromide<br>* Aclidinium bromide 200 μg, oral inhalation twice per day 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks of treatment.<br>|
| Placebo Comparator: 3<br>Dose-match placebo, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on placebo will receive open label 400µg aclidinium bromide for 40 weeks | Drug: Placebo<br>* Dose-matched placebo, oral inhalation twice per day for 12 weeks. At week 12, patients who were on placebo will receive open label 400 µg aclidinium bromide for 40 weeks of treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF) | Change from baseline (Week 0) to Week 12 | 
| Part B: Morning Predose (Trough) FEV1 | Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF) | Change from baseline (Week 0) to 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: Peak Forced Expiratory Volume in 1 Second (FEV1) | Change from baseline in peak FEV1 at week 12, Last Observation Carried Forward (LOCF) | Change from baseline (Week 0) to Week 12 | 
| Part B: Peak FEV1 | Change from Baseline in Peak FEV1 (L) at Week 52, Last Observation Carried Forward (LOCF) | Change from baseline (Week 0) to 52 Weeks | 

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