Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma

Phase 2 Completed 2283 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start: 2009-07
Primary completion: 2011-05
Completion: 2011-05

Outcome

Missed primary endpoint

paper No significant difference was observed in the primary outcome of time to first serious asthma exacerbation PMID 25649209 ↗

Publications

Beasley RW, Donohue JF, Mehta R, Nelson HS, Clay M, Moton A, Kim HJ, Hederer BM. Effect of once-daily indacaterol maleate/mometasone furoate on exacerbation risk in adolescent and adult asthma: a double-blind randomised controlled trial. BMJ Open. 2015 Feb 3;5(2):e006131. doi: 10.1136/bmjopen-2014-006131.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Indacaterol	Other / unclassified	500 ug	Inhaled
Comparator	Mometasone	Other / unclassified	400 ug	Inhaled