At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 743 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 Tiotropium. A 24-week, Double-blind Study With 500 µg Roflumilast Once Daily Versus Placebo. The HELIOS Study
In Brief
A Phase 3 clinical trial evaluating Roflumilast and Placebo for Chronic Obstructive Pulmonary Disease. Completed, enrolled 743 participants across 103 sites in 7 countries.
Detailed Summary
The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of tiotropium. 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--
ConditionsChronic Obstructive Pulmonary Disease
CountriesAustria, France, Germany, Hungary, Italy, Spain, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
First PostedJan 2007
Primary CompletionJan 2008
Study CompletionJul 2008
TodayJul 2026
First PostedJan 19, 2007
Enrollment StartJan 1, 2007
Primary CompletionJan 1, 2008
Study CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 19.5 years ago
Interventions
Roflumilastdrug
500 µg, once daily, oral administration in the morning
Placebodrug
once daily