Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
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|ClinicalTrials.gov Identifier: NCT01443845|
Recruitment Status : Completed
First Posted : September 30, 2011
Results First Posted : January 25, 2017
Last Update Posted : April 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|COPD COPD Exacerbation Lung Diseases Respiratory Disorders Pulmonary Disease Chronic Obstructive Lung Diseases Chronic Obstructive Airway Disease||Drug: Roflumilast Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2354 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||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)|
|Actual Study Start Date :||September 30, 2011|
|Actual Primary Completion Date :||November 30, 2015|
|Actual Study Completion Date :||January 31, 2016|
Roflumilast 500 µg, oral administration, once per day
Other Name: Daliresp
Placebo Comparator: 2
Dose-matched placebo, oral administration, once per day.
- Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year. [ Time Frame: Baseline to Week 52 ]Rate of moderate or severe COPD exacerbations, defined as requiring oral or parenteral glucocorticosteroids (moderate) or requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.
- Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations) [ Time Frame: Week 0 (Visit 2) to Week 52 ]Rate of moderate or severe COPD exacerbations, defined as requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.
- Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics [ Time Frame: Week 0 (Visit 2) to Week 52 ]Rate of moderate or severe COPD exacerbations treated with antibiotics during the double-blind treatment period.
- Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Week 0 (Visit 2) to Week 52 ]Mean change from randomization (Visit 2) over 52 weeks of treatment in predose forced expiratory volume in 1 second (FEV1)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443845
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