Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 154
Healthy volunteers: no

Brief summary:
The purpose of this study is compare the effect of different doses of tiotropium delivered by the HandiHaler and Respimat device on lung function. Additionally, the study will investigate the pharmacokinetic profile of these different doses. Studying the pharmacokinetic profile shows what happens to the medication in the body over a period of hours and provides information on potential effects of the medication.

Detailed description:

Arms:
arm 1: Tiotropium inhalation solution low dose arm 2: Tiotropium inhalation solution medium dose arm 3: Tiotropium inhalation solution high dose arm 4: Tiotropium inhalation powder 18mcg arm 5: Placebo inhalation solution

Interventions: intervention 1: Tiotropium medium intervention 2: Tiotropium low intervention 3: Tiotropium high intervention 4: Tiotropium 18mcg intervention 5: Tiotropium placebo
Intervention descriptions: intervention 1: Tiotropium inhalation solution medium dose intervention 2: Tiotropium inhalation solution low dose intervention 3: Tiotropium inhalation solution high dose intervention 4: Tiotropium inhalation powder 18mcg intervention 5: Placebo inhalation solution

Protocol document: