Conditions: Asthma
Keywords: Bronchial Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 528
Healthy volunteers: no

Brief summary:
Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma.

Secondary objective: To assess the safety and tolerability of ciclesonide.

Detailed description:

Arms:
arm 1: double-blind arm 2: double-blind arm 3: double-blind

Interventions: intervention 1: Ciclesonide intervention 2: Ciclesonide intervention 3: Placebo
Intervention descriptions: intervention 1: Ciclesonide MDI 40 µg BID over twelve weeks intervention 2: Ciclesonide MDI 80 µg BID over twelve weeks intervention 3: Placebo MDI over twelve weeks

Protocol document: