Conditions: Asthma
Keywords: Asthma, QMF149, fixed combination of indacaterol and mometasone furoate
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 31
Healthy volunteers: no

Brief summary:
This study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500 μg/mometasone furoate 400 μg via the Twisthaler® device in adult patients with persistent asthma.

Detailed description:

Arms:
arm 1: In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg / mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days. arm 2: In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twistheler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg / mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.

Interventions: intervention 1: indacaterol maleate/mometasone furoate intervention 2: placebo to indacaterol maleate/mometasone furoate intervention 3: fluticasone proprionate / salmeterol xinafoate
Intervention descriptions: intervention 1: Indacaterol maleate 250 μg / mometasone furoate 200 μg delivered via the Twisthaler device. intervention 2: Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device. intervention 3: Fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg delivered via the Accuhaler® device.

Protocol document: