Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 243
Healthy volunteers: no

Brief summary:
This is a 6 week study to assess the effect of BI 671800 in patients with asthma. It is a double blind, parallel arm trial testing the safety and efficacy of BI 671800. The main objective is to assess the effect on lung function. The study will also provide data on the pharmacokinetics of BI 671800.

Detailed description:

Arms:
arm 1: Patients receive BI 671800 capsules twice daily arm 2: Patients receive Montelukast encapsulated tablets once daily arm 3: Patients receive placebo capsules and/or encapsulated placebo tablets

Interventions: intervention 1: BI 671800 intervention 2: Placebo intervention 3: Montelukast
Intervention descriptions: intervention 1: Double blind randomised parallel group study to assess efficacy and tolerability of BI 617800 in patients with symptomatic asthma intervention 2: Patients receive placebo capsules and/or encapsulated tablets intervention 3: Double blind randomised parallel group study to assess efficacy and tolerability of BI 671800 in patients with symptomatic asthma

Protocol document: