Conditions: Asthma
Keywords: Asthma Indacaterol QAB149
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 36
Healthy volunteers: no

Brief summary:
This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two different formulations of indacaterol maleate, both administered via the Concept1 device. The study aims to determine whether the novel formulation has a similar clinical profile as the established formulation.

Detailed description:

Arms:
arm 1: 75 µg indacaterol maleate lactose blend (LB) + placebo to indacterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days. arm 2: 75 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. arm 3: 37.5 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. arm 4: Placebo to indacaterol PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.

Interventions: intervention 1: 75 µg indacaterol maleate (LB) intervention 2: 75 µg indacaterol maleate (PoS) intervention 3: 37.5 µg indacaterol maleate (PoS) intervention 4: placebo to indacaterol (LB) intervention 5: placebo to indacaterol (PoS)
Intervention descriptions: intervention 1: 75 µg indacaterol maleate lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. intervention 2: 75 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days. intervention 3: 37.5 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days. intervention 4: Placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. intervention 5: Placebo to indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.

Protocol document: