Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)

Study Overview
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Brief Summary
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The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.

Official Title
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A Long-term, Randomized, Double-blind Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide at Two Dose Levels When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Aclidinium bromide
* Drug: Aclidinium bromide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completion of a lead-in study (NCT00891462) Exclusion Criteria: Use or anticipated use of any medication prohibited in this study Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic (ECG) results or the presence of abnormities in physical examination findings The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow angle glaucoma) QTcB of >500 msec on both the pre-dose and post-dose ECG Women who are pregnant, intend to become pregnant, or are breast-feeding A life expectancy of less than 1 year Noncompliance with IP dosing and/or attending clinic visits during the lead-in study Significant interruption of double-blind therapy during the transition from the lead-in study into the extension study.

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 52 weeks of treatment | Drug: Aclidinium bromide<br>* Aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment<br>|
| Experimental: 2<br>Aclidinium bromide dose, inhaled, for 52 weeks of treatment | Drug: Aclidinium bromide<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 (Visit 2 of lead-in Study NCT00891462, [LAS-MD-33]) to Week 52 (Week 64 From Start of NCT00891462, [LAS-MD-33]) in Morning Predose (Trough) FEV1 | Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Peak FEV1 | Change From Baseline (Visit 2 of study NCT00891462, [LAS-MD-33])in Peak FEV1 in liters at Week 52 (Week 64 from the start of NCT00891462, [LAS-MD-33]). | 52 weeks | 

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