At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 2,354 enrolled
Drug / intervention
Roflumilast +1 moredrug
Likely dose
Roflumilast 500 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 4 clinical trial evaluating Roflumilast and Placebo for COPD and 6 related conditions. Completed, enrolled 2,354 participants across 338 sites in 17 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD, COPD Exacerbation, Lung Diseases, Respiratory Disorders, Pulmonary Disease, Chronic Obstructive Lung Diseases, Chronic Obstructive Airway Disease
CountriesArgentina, Canada, Chile, Colombia, Italy, Malaysia, Mexico, Peru, Philippines, Romania, Russia, Serbia, Spain, Taiwan, Thailand, Ukraine, United States
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 2011
Enrollment StartSep 2011
Primary CompletionNov 2015
Study CompletionJan 2016
TodayJul 2026
First PostedSep 30, 2011
Enrollment StartSep 30, 2011
Primary CompletionNov 30, 2015
Study CompletionJan 31, 2016
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 14.8 years ago
Interventions
Roflumilastdrug
Roflumilast 500 µg, oral administration, once per day
Placebodrug
Dose-matched placebo, oral administration, once per day.