Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD antimuscarinic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 414
Healthy volunteers: no

Brief summary:
The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide, respectively, after 6 weeks of treatment.

Detailed description:

Arms:
arm 1: Aclidinium bromide 400 µg administered twice per day during 6 weeks of treatment arm 2: Tiotropium bromide 18 µg administered once per day during 6 weeks of treatment arm 3: Placebo comparator administered during 6 weeks of treatment

Interventions: intervention 1: Aclidinium bromide intervention 2: Tiotropium intervention 3: Placebo
Intervention descriptions: intervention 1: Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) intervention 2: Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h) intervention 3: Dosage form: Dry powder Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h).

Protocol document: