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A Randomized, Multi-center, Parallel Group, Double Blind, Study to Assess the Safety of QMF Twisthaler® (500/400 µg) and Mometasone Furoate Twisthaler® (400 µg) in Adolescent and Adult Patients With Persistent Asthma
Study CQMF149A2210 evaluated the safety of QMF149 Twisthaler® 500/400 μg, a fixed dose combination of indacaterol 500 μg, a once daily β2 agonist, and mometasone furoate 400 μg, an inhaled corticosteroid (ICS) that is approved for use in the treatment of asthma. The objective of this safety trial was to assess the effect of treatment on the incidence of serious asthma exacerbations, defined as asthma related hospitalization and/or intubation and/or death. This was an event driven trial.
Details
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 2283 |
| Start date | 2009-07 |
| Completion | 2011-05 |
Conditions
- Asthma
Interventions
- QMF149 Twisthaler®
- Mometasone Twisthaler®
Primary outcomes
- Time to First Serious Asthma Exacerbation — Up to 21 months
Defined as the number of days from start of treatment up to the first date when an asthma exacerbation becomes serious. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.
Countries
United States, Brazil, Colombia, Czechia, Hungary, India, Peru, Slovakia, South Korea