Clinical trial NCT01959412
Conditions: Asthma
Keywords: wheezing, short of breath, laba, inhaler
Sponsor: Novartis Pharmaceuticals
Start date: 2013-11-01; Completion date: 2014-03-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the efficacy of indacaterol 55µg once daily (and 27.5 µg twice) in QVA149 compared to 75 µg indacaterol monotherapy.

Detailed description:

Arms: arm 1: Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening arm 2: Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening arm 3: Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening arm 4: Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening arm 5: Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening arm 6: Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
Interventions: intervention 1: Indacaterol 27.5 mcg intervention 2: Indacaterol 37.5 intervention 3: Indacaterol 55 mcg intervention 4: Indacaterol 75 mcg intervention 5: Indacaterol 150 mcg intervention 6: Placebo
Intervention descriptions: intervention 1: indacaterol 27.5 mcg twice daily inhaled once via inhaler intervention 2: Indacaterol 37.5 mcg once daily, inhaled once via inhaler intervention 3: Indacaterol 55 mcg once daily, inhaled once via inhaler intervention 4: Indacaterol 75 mcg once daily, inhaled once via inhaler intervention 5: Indacaterol 150 mcg once daily, inhaled once via inhaler intervention 6: Placebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher

Protocol documents: