At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Repeat Dose Cross-over Study to Assess the Bronchodilator Effects of Once Daily QVM149 Following Morning or Evening Dosing for 14 Days Compared to Placebo in Patients With Asthma
In Brief
A Phase 2 clinical trial evaluating Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose), Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose), and 1 other intervention for Asthma. Completed, enrolled 38 participants across 7 sites in 3 countries.
Detailed Summary
This was a randomized, placebo-controlled, double-blind, six-sequence, three-period cross-over study in asthma patients. The study consisted of a 14-day screening period, followed by a 14-day run-in period, and a treatment epoch which consists of three treatment periods, with a minimum duration of 14 days each followed (for the 2 first treatment periods) by a wash-out period. The duration of each treatment period may be extended up to a duration of 18 days if needed for operational reasons. The third treatment period was followed by a Study Completion evaluation at 1-7 days following the last dose. The treatment periods were separated by wash-out periods of 14 to 21 days duration.
Study Details
Timeline
Interventions
Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)
QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)
Placebo (morning dose) and placebo (evening dose)