Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1137
Healthy volunteers: no

Brief summary:
The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily, orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium (Spiriva Handihaler®) monotherapy on lung function in patients with COPD.

Detailed description:

Arms:
arm 1: 2 puffs Olodaterol from Respimat and one capsule Tiotropium by Handihaler once daily in am, co-administered arm 2: 2 puffs placebo inhalation solution from Respimat and one capsule Tiotropium by Handihaler once daily in am, co-administered

Interventions: intervention 1: Tiotropium intervention 2: Placebo matching Olodaterol intervention 3: Tiotropium intervention 4: Olodaterol
Intervention descriptions: intervention 1: marketed product intervention 2: one dose intervention 3: marketed product intervention 4: one dose

Protocol document: