At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 933 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.
Effect of Roflumilast in COPD Patients Treated With Salmeterol. A 24-week, Double-blind Study With 500 μg Roflumilast Once Daily Versus Placebo. The EOS Study
In Brief
A Phase 3 clinical trial evaluating Roflumilast and Placebo for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 933 participants across 134 sites in 10 countries.
Detailed Summary
The aim of the study is to compare the efficacy of roflumilast on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of salmeterol. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Spain, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2006
First PostedApr 2006
Primary CompletionJul 2007
Study CompletionFeb 2008
TodayJul 2026
First PostedApr 12, 2006
Enrollment StartApr 1, 2006
Primary CompletionJul 1, 2007
Study CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.2 years ago
Interventions
Roflumilastdrug
500 µg, once daily, oral administration in the morning
Placebodrug
once daily