Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 17183
Healthy volunteers: no

Brief summary:
Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.

Detailed description:

Arms:
arm 1: Patients receive one of the active tiotropium arms daily arm 2: Patients receive one of the active tiotropium arms daily arm 3: Patients receive one of the active tiotropium arms daily

Interventions: intervention 1: tiotropium 18 mcg intervention 2: tiotropium 1.25 mcg (2 actuations/day) intervention 3: tiotropium 2.5 mcg (2 actuations/day)
Intervention descriptions: intervention 1: HandiHaler intervention 2: soft mist inhaler 2 actuations=2 puffs/day intervention 3: soft mist inhaler (2 actuations=2 puffs/day)

Protocol document: