Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 470
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate long-term safety and patient acceptability of COMBIVENT RESPIMAT Inhalation Spray as compared to the COMBIVENT Inhalation Aerosol Chlorofluorocarbon-Metered Dose Inhaler (CFC-MDI) and the free combination of ATROVENT Hydrofluoroalkane (HFA) and albuterol Hydrofluoroalkane (HFA) inhalation aerosols.

Detailed description:

Arms:
arm 1: patient to take 1 inhalation 4 times a day arm 2: patient to take 2 inhalations 4 times a day arm 3: patient to take 2 inhalations of each 4 times a day

Interventions: intervention 1: Combivent CFC-MDI intervention 2: Combivent Respimat 20/100 mcg intervention 3: Atrovent HFA 42 mcg + Albuterol HFA 200 mcg
Intervention descriptions: intervention 1: 36/206 mcg Four times a day (QID) intervention 2: Open label randomized parallel intervention 3: Open label randomized parallel

Protocol document: