Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 301
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the safety, efficacy and tolerability of R940343 in the treatment of mild to moderate asthma.

Detailed description:
The study is a multi-center, randomized, double-blind, placebo-controlled, parallel group study comparing 2 doses of inhaled R343 bid to placebo over 8 weeks in patients with mild to moderate allergic asthma. Patients who meet specific inclusion and exclusion criteria after an initial screening evaluation and a single-blind, run-in period will be randomized to receive either R343 or placebo.

Arms:
arm 1: R343 2mg, 2 puffs bid arm 2: None arm 3: R343 1mg, 1 puff bid

Interventions: intervention 1: Placebo intervention 2: R940343 1mg intervention 3: R940343 2mg
Intervention descriptions: intervention 1: 1 puff bid or 2 puffs bid intervention 2: R343 1mg, 1 puff bid intervention 3: R343 2mg, 2 puffs bid

Protocol document: