Conditions: Asthma
Keywords: Asthma LABA Safety
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2283
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD) arm 2: Mometasone Twisthaler®, 400 µg QD

Interventions: intervention 1: QMF149 Twisthaler® intervention 2: Mometasone Twisthaler®
Intervention descriptions: intervention 1: Once daily via multi-dose dry-powder inhaler intervention 2: Once daily via multi-dose dry-powder inhaler

Protocol document: