Clinical trial NCT00557440
Conditions: Asthma
Keywords: Asthma QMF Indacaterol Mometasone
Sponsor: Novartis
Start date: 2007-11-01; Completion date: 2008-04-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is designed to provide data about the 24 hours FEV1 profile, safety and tolerability of indacaterol/mometasone TWISTHALER device compared to placebo and using fluticasone/salmeterol as an active control.

Detailed description:

Arms: arm 1: In Treatment Period 1 (Days 1 \& 2) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.

In Treatment Period 2 (Days 8 \& 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.

In Treatment Period 3 (Days 15 \& 16) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.

Each treatment period was separated by a 6-day washout period. arm 2: In Treatment Period 1 (Days 1 \& 2) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.

In Treatment Period 2 (Days 8 \& 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.

In Treatment Period 3 (Days 15 \& 16) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.

Each treatment period was separated by a 6-day washout period. arm 3: In Treatment Period 1 (Days 1 \& 2) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.

In Treatment Period 2 (Days 8 \& 9) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.

In Treatment Period 3 (Days 15 \& 16) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.

Each treatment period was separated by a 6-day washout period.
Interventions: intervention 1: fluticasone propionate/salmeterol intervention 2: indacaterol maleate / mometasone furoate intervention 3: placebo to indacaterol/mometasone intervention 4: placebo to fluticasone propionate/salmeterol
Intervention descriptions: intervention 1: Fluticasone propionate/salmeterol 250/50 μg twice daily delivered via MDDPI. intervention 2: Indacaterol maleate / mometasone furoate 500/400 μg once daily delivered via the TWISTHALER device. intervention 3: Placebo to indacaterol maleate/mometasone furoate delivered via the TWISTHALER device. intervention 4: Placebo to fluticasone propionate / salmeterol delivered via MDDPI.

Protocol documents: