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A 52-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Roflumilast 500 μg on Exacerbation Rate in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Treated With a Fixed-Dose Combination of Long-Act

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Conditions:		COPD - COPD Exacerbation - Lung Diseases - Respiratory Disorders - Pulmonary Disease - Chronic Obstructive Lung Diseases - Chronic Obstructive Airway Disease
Purpose:		To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.
Study Summary:
Criteria:		Inclusion Criteria: - 1. Male or female patients at least 40 years of age - 2. History of COPD (according to GOLD 2010) for at least 12 months prior to Screening (Visit 1) associated with chronic productive cough for 3 months in each of 2 consecutive years (with other causes of productive cough excluded). Only patients with chronic bronchitis will be included (concomitant emphysema is permitted) - 3. Forced expiratory volume after 1 second (FEV1)/forced vital capacity (FVC) ratio (postbronchodilator) < 70% at Screening (Visit 1) - 4. FEV1 (postbronchodilator) ≤ 50% of predicted at Screening (Visit 1) - 5. At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 1) - 6. Patients must be on FDC LABA/ICS treatment ≥ 3 months prior to Screening (Visit 1) - 7. Former smokers (defined as smoking cessation at least 1 year ago) or current smokers (including patients who ceased smoking within the past year) both with a smoking history of at least 20 pack-years Exclusion Criteria: - 1. Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics or systemic glucocorticosteroids within 4 weeks of Screening (Visit 1) (ie, patients must be clinically stable) - 2. Known alpha-1-antitrypsin deficiency - 3. Current diagnosis of asthma (either controlled or uncontrolled) (Note: History of childhood asthma is not exclusionary.) - 4. Body mass index (BMI) ≥ 45 kg/m2 - 5. Patients with a history (within 5 years) or current diagnosis of cancer other than basal or squamous cell skin cancer
NCT ID:		NCT01443845
Primary Contact:		Study Director Paul Rowe, MD Forest Laboratories Sandra Beaird, PhD Phone: 1-800-678-1605 ext. 66297 Email: info@forestpharm.com
Backup Contact:		N/A
Location Contact:		Towson, Maryland 21204 United States There is no listed contact information for this specific location. Site Status: Recruiting

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