Conditions: Asthma
Keywords: asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 335
Healthy volunteers: no

Brief summary:
To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.

Detailed description:

Arms:
arm 1: indacaterol acetate 75 µg od delivered via Concept 1 inhaler

Background therapy: mometasone furoate 200 mcg od arm 2: indacaterol acetate 150 µg od delivered via Concept 1 inhaler

Background therapy: mometasone furoate 200 mcg od arm 3: placebo delivered via Concept 1 inhaler

Background therapy: mometasone furoate 200 mcg od

Interventions: intervention 1: indacaterol intervention 2: placebo intervention 3: mometasone furoate
Intervention descriptions: intervention 1: indacaterol acetate 75 µg or indacaterol acetate 150 µg delivered via Concept 1 inhaler intervention 2: placebo delivered via Concept 1 inhaler intervention 3: via Twisthaler inhaler

Protocol document: