Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 9
Healthy volunteers: no

Brief summary:
The aim of the study is to assess and compare efficacy and safety of BI 54903 at three different dosages (b.i.d)., fluticasone propionate hydrofluoroalkane (HFA) metered dose inhaler (MDI) at a dose of 440 mcg b.i.d and low dose fluticasone propionate 88 mcg b.i.d. over an 8-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled medium dose ICS therapy as demonstrated by a decrease in forced expiratory volume in one second (FEV1) range 10 to 25 % and an asthma control questionnaire-6 (ACQ-6) equal or greater than 1.5 at time of randomisation.

Detailed description:

Arms:
arm 1: patient to receive Respimat inhaler containing low dose BI 54903 plus placebo matching hydrofluoroalkane (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 440 mcg ICS plus placebo matching Respimat inhaler arm 5: Fluticasone HFA MDI containing 88 mcg ICS plus placebo matching Respimat inhaler

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

Protocol document: