Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 206
Healthy volunteers: no

Brief summary:
This study will compare efficacy and safety of different regimens of olodaterol administration in asthma (once daily, twice daily) with placebo in a complete cross-over design each within one of the two daily dose groups (medium or high daily dose).

Detailed description:

Arms:
arm 1: Olodaterol medium daily dose given either as once daily or split into two low doses daily or placebo only in randomised sequence of three cross-over treatment phases arm 2: Olodaterol high daily dose given either as once daily or split into two medium doses daily or placebo only in randomised sequence of three cross-over treatment phases

Interventions: intervention 1: Placebo twice daily intervention 2: Olodaterol low daily dose twice daily intervention 3: Olodaterol medium daily dose twice daily intervention 4: Placebo twice daily intervention 5: Olodaterol high daily dose once daily and placebo intervention 6: Olodaterol medium daily dose once daily and placebo
Intervention descriptions: intervention 1: Inhaled Placebo of Olodaterol twice daily intervention 2: Inhaled Olodaterol medium daily dose administered as low dose twice daily intervention 3: Inhaled Olodaterol high daily dose administered as medium dose twice daily intervention 4: Inhaled Placebo of Olodaterol twice daily intervention 5: Inhaled Olodaterol high daily dose administered as one full dose once daily and placebo once daily intervention 6: Inhaled Olodaterol medium daily dose administered as one full dose once daily and placebo once daily

Protocol document: