Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
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Brief Summary
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The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.

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

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: Aclidinium bromide 200 μg bid
* Drug: Aclidinium bromide 400 μg bid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines). Post-salbutamol (FEV1) < 80% and ≥30% of predicted normal value and Post-salbutamol FEV1/FVC < 70%. Current or ex-smokers of ≥10 pack-years. Exclusion Criteria: Patients with no history or current diagnosis of asthma. No evidence of an exacerbation within 6 weeks prior to the screening visit. No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities. No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aclidinium bromide 200 μg bid<br>Aclidinium bromide 200 μg twice-daily via inhalation | Drug: Aclidinium bromide 200 μg bid<br>* Aclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks<br>|
| Experimental: Aclidininum bromide 400 μg bid<br>Aclidinium bromide 400 μg twice-daily via inhalation | Drug: Aclidinium bromide 400 μg bid<br>* Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo twice-daily by inhalation for 24 weeks<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 the First Second (FEV1) at Week 24 on Treatment |  | Baseline and Week 24 | 
| Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment |  | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment |  | Baseline and Week 24 | 
| Percentage of Patients Who Achieved at Least a 1-unit Decrease From Baseline in TDI Focal Score at Week 24 on Treatment | Number of patients achieving a clinically meaningful improvement (≥1-unit) in Transition Dyspnoea Index (TDI) focal score at Week 24 on Treatment | Week 24 | 
| Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at Week 24 on Treatment | Number of patients who achieved a clinically meaningful improvement (≥4-units) in Saint George Respiratory Questionnaire (SGRQ) total score at week 24 on treatment | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, antimuscarinic, COPD