Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33)

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period, 12-week double-blind treatment, and 2-week follow-up phone visit.

Official Title
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Efficacy and Safety of Aclidinium Bromide at Two Dose Levels (200 μg Twice Daily, 400 μg Twice Daily) vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Aclidinium bromide
* 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, 2009; 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 dose, inhaled, for 12 weeks of treatment | Drug: Aclidinium bromide<br>* Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment<br>|
| Experimental: 2<br>Aclidinium bromide dose, inhaled, for 12 weeks of treatment | Drug: Aclidinium bromide<br>* Aclidinium bromide 400 μg, oral inhalation twice per day for 12 weeks of treatment<br>|
| Placebo Comparator: 3<br>Inhaled placebo for 12 weeks | Drug: Placebo<br>* Dose-matched placebo, oral inhalation twice per day for 12 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 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 to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1) | Change From Baseline in Peak FEV1 (L) at Week 12, Last Observation Carried Forward (LOCF) | Change from Baseline to 12 weeks | 

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