drugset / Trial / NCT03158311
Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this trial was to demonstrate that the efficacy of two treatment arms of the fixed-dose combination product QVM149 was non-inferior to the efficacy of the free combination arm of salmeterol/ fluticasone+ tiotropium in uncontrolled moderate to severe asthmatic patients. The planned duration of treatment in this study was 24 weeks, followed up by a 7-day follow-up period.
Timeline
- Start
- 2018-02-05
- Primary completion
- 2019-07-12
- Completion
- 2019-07-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluticasone | Other / unclassified | 500 ug | Inhaled |
| Subject | Glycopyrronium | Unknown | 50 ug | Inhaled |
| Subject | Indacaterol | Other / unclassified | 150 ug | Inhaled |
| Subject | Mometasone | Other / unclassified | 80 ug | Inhaled |
| Subject | Mometasone | Other / unclassified | 160 ug | Inhaled |
| Comparator | Salmeterol | Other / unclassified | 50 ug | Inhaled |
| Comparator | Tiotropium | Other / unclassified | 5 ug | Inhaled |