NCT01443845

Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,354 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD
• COPD Exacerbation
• Lung Diseases
• Respiratory Disorders
• Pulmonary Disease
• Chronic Obstructive Lung Diseases
• Chronic Obstructive Airway Disease

Interventions

Type	Name	Description
DRUG	Roflumilast	Roflumilast 500 µg, oral administration, once per day
DRUG	Placebo	Dose-matched placebo, oral administration, once per day.

Timeline

• Start date: 2011-09-30
• Primary completion: 2015-11-30
• Completion: 2016-01-31
• First posted: 2011-09-30
• Last updated: 2017-04-13
• Results posted: 2017-01-25

Locations

338 sites across 17 countries: United States, Argentina, Canada, Chile, Colombia, Italy, Malaysia, Mexico, Peru, Philippines, Romania, Russia, Serbia, Spain, Taiwan, Thailand, Ukraine