Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: no

Brief summary:
The aim of the study is to assess and compare efficacy and safety of BI 54903 at 3 doses twice daily (b.i.d.), fluticasone propionate hydrofluoroalkane metered dose inhaler (HFA MDI) at a dose of 220 mcg b.i.d. and placebo b.i.d. over an 8-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled on low dose Inhaled corticosteroid (ICS) as demonstrated by a decrease in forced expiratory volume in one second (FEV1 (range 10-25%) and an asthma control questionnaire (ACQ-6) greater or equal 1.5 at time of randomisation

Detailed description:

Arms:
arm 1: Respimat inhaler containing low dose BI 54903 plus placebo matching hydrofluoralkane (HFA) metered dose inhaler (MDI) arm 2: Respimat inhaler containing medium dose BI 54903 plus placebo matching HFA MDI arm 3: Respimat inhaler containing high dose BI 54903 plus placebo matching HFA MDI arm 4: Fluticasone HFA MDI containing ICS plus placebo matching Respimat inhaler arm 5: Placebo matching Respimat inhaler plus placebo matching HFA MDI

Interventions: intervention 1: Placebo intervention 2: BI 54903 intervention 3: Fluticasone propionate
Intervention descriptions: intervention 1: Placebo matching fluticasone propionate HFA MDI intervention 2: BI 54903 intervention 3: Fluticasone propionate

Protocol document: