Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 79
Healthy volunteers: no

Brief summary:
A randomized, placebo-controlled, double-blind, parallel group, multi center study to assess the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation (Hospital Discharge 1)

Detailed description:

Arms:
arm 1: Patient to receive one tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler arm 2: Patient to receive one placebo capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler

Interventions: intervention 1: tiotropium bromide intervention 2: Placebo
Intervention descriptions: intervention 1: 18 mcg once a day (QD) intervention 2: once a day (QD)

Protocol document: