Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the evening vs. the FDC once daily in the morning and formoterol fumarate once in the evening vs. formoterol fumarate twice daily. The study will assess pulmonary function and symptoms in patients with moderate to severe COPD.

Official Title
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A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter, 4-Week Pilot Study to Assess Symptoms in Stable, Moderate to Severe COPD Patients Taking Aclidinium Bromide 200 mcg Once Daily in Combination With Formoterol Fumarate Once or Twice Daily Versus Formoterol Fumarate Twice Daily

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Once-daily aclidinium/formoterol
* Drug: Twice-daily formoterol fumarate
* Drug: Placebo to formoterol fumarate
* Drug: Once-daily formoterol fumarate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe COPD Smoking history of greater or equal to 10 pack-years Diagnosis of stable moderate to severe COPD as defined by the GOLD Guidelines Postbronchodilator FEV1 from 30% to 79% of predicted values, inclusive Postbronchodilator FEV1/FVC ratio < 0.70 Exclusion Criteria: History or presence of asthma, allergic rhinitis, or exercise-induced bronchospasm Hospitalization for an acute COPD exacerbation in the 3 months prior to study entry Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry Eosinophil count of at least 600 cells/mm3 Long term oxygen therapy > 15 hours a day

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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: Once-daily aclidinium/formoterol<br>Aclidinium bromide 200 µg/ formoterol fumarate 12 µg fixed-dose combination (FDC) once-daily in the morning, plus placebo once-daily in the evening | Drug: Once-daily aclidinium/formoterol<br>* Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning<br>Drug: Placebo to formoterol fumarate<br>* Inhaled placebo to formoterol fumarate once-daily in the evening<br>|
| Experimental: Morning aclidinium/formoterol plus evening formoterol<br>Aclidinium bromide 200 µg/formoterol fumarate 12 µg FDC once-daily in the morning, plus formoterol fumarate 12µg once-daily in the evening | Drug: Once-daily aclidinium/formoterol<br>* Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning<br>Drug: Once-daily formoterol fumarate<br>* Inhaled formoterol fumarate 12 μg once-daily in the evening<br>|
| Active Comparator: Formoterol BID<br>Formoterol fumarate 12 µg twice-daily (BID) | Drug: Twice-daily formoterol fumarate<br>* Inhaled formoterol fumarate 12 µg twice-daily (BID)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Weekly Average Nocturnal Symptom Scores | Nocturnal Symptom Score Scale: 0 = None; 1 = Symptoms causing early awakening or awakening once during the night; 2 = Symptoms causing early awakening or awakening two or more times during the night; 3 = Symptoms causing awakening for most time during the night, 4 = Symptoms which were so severe that I could not sleep at all | Week 4 of treatment | 
| Change From Baseline in Weekly Average Daily (24 Hour) Sputum Volume Scores | Sputum Volume Score Scale: 0 = None; 1 = The amount of one teaspoon; 2 = The amount of one tablespoon; 3 = More than one tablespoon | Week 4 of treatment | 

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