At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 64 enrolled
Drug / intervention
Roflumilast +2 moredrug
Likely dose
Not stated in 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.
A Phase 2, Randomized, Double-Blind, 4-week Crossover Trial to Investigate the Effect of a Once-Daily Combination of 500 µg Roflumilast Plus 10 mg Montelukast vs 10 mg Montelukast Alone on Pulmonary Function, Asthma Symptoms, and Inflammatory Markers in Subjects With Severe Asthma Not Adequately Controlled With a Combination of at Least Medium Dose Inhaled Corticosteroids and Long-Acting Beta Agonists Maintenance Therapy
In Brief
A Phase 2 clinical trial evaluating Roflumilast, Roflumilast placebo, and 1 other intervention for Asthma. Completed, enrolled 64 participants across 13 sites in 3 countries.
Detailed Summary
This study will evaluate the effect of roflumilast 500 μg once daily (QD) plus montelukast 10 mg QD versus 10 mg montelukast QD alone on predose (trough) prebronchodilator forced expiratory volume in the first second (FEV1).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesGermany, Hungary, South Africa
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 2013
Enrollment StartFeb 2013
Primary CompletionOct 2013
TodayJul 2026
First PostedJan 10, 2013
Enrollment StartFeb 1, 2013
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.5 years ago
Interventions
Roflumilastdrug
Roflumilast was supplied in tablets.
Roflumilast placebodrug
Roflumilast placebo was supplied in tablets.
Montelukastdrug
Montelukast was supplied in tablets.