Trial record 2 of 3386 for: Open Studies | "Lung Diseases"
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
This study is currently recruiting participants.
Verified September 2013 by Forest Laboratories
Information provided by (Responsible Party):
First received: September 28, 2011
Last updated: September 30, 2013
Last verified: September 2013
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.
Chronic Obstructive Lung Diseases
Chronic Obstructive Airway Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS)|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Forest Laboratories:
Primary Outcome Measures:
- Rate of moderate or severe COPD exacerbations per subject per year [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Prebronchodilator Forced Expiratory Volume in 1 second (FEV1) in Liters [ Time Frame: Change from randomization, Week 0 (Visit 2) to Week 52 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Roflumilast 500 µg, oral administration, once per day
Other Name: Daliresp
Placebo Comparator: 2
Dose-matched placebo, oral administration, once per day.
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