drugset / Trial / NCT03108027
Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma
RandomizedCrossoverQuadruple-blindTreatment
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.
Timeline
- Start
- 2017-06-26
- Primary completion
- 2018-02-24
- Completion
- 2018-02-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | QVM149 | Unknown | 50 ug | — |
| Subject | QVM149 | Unknown | 80 ug | — |
| Subject | QVM149 | Unknown | 150 ug | — |