Status:
COMPLETED
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
Lead Sponsor:
AstraZeneca
Conditions:
COPD
COPD Exacerbation
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
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.
Eligibility Criteria
Inclusion
- 1\. Male or female patients at least 40 years of age
- 2\. History of COPD (according to Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] 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
- 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
Key Trial Info
Start Date :
September 30 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2016
Estimated Enrollment :
2354 Patients enrolled
Trial Details
Trial ID
NCT01443845
Start Date
September 30 2011
End Date
January 31 2016
Last Update
April 13 2017
Active Locations (338)
Enter a location and click search to find clinical trials sorted by distance.
1
Forest Investigative Site 081
Anniston, Alabama, United States, 36207
2
Forest Investigative Site 065
Athens, Alabama, United States, 35611
3
Forest Investigative Site 131
Florence, Alabama, United States, 35630
4
Forest Investigative Site 073
Mobile, Alabama, United States, 36608