Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 457
Healthy volunteers: no

Brief summary:
A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.

Detailed description:

Arms:
arm 1: Oral inhalation once daily of placebo matching tiotropium via handihaler arm 2: Oral inhalation once daily of 18mcg tiotropium via handihaler

Interventions: intervention 1: tiotropium intervention 2: Placebo
Intervention descriptions: intervention 1: Oral inhalation once daily of 18mcg tiotropium via handihaler intervention 2: Oral inhalation once daily of placebo matching tiotropium via handihaler

Protocol document: