Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 79
Healthy volunteers: no

Brief summary:
The present trial is conducted to further assess the efficacy by means of serial spirometry, safety and tolerability of three doses of aclidinium bromide administered twice a day compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).after 7 days on treatment. Every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between them. The trial starts with a run in phase of 11 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.

Detailed description:

Arms:
arm 1: Aclidininum bromide 100 μg twice daily by inhalation arm 2: Aclidininum bromide 200 μg twice daily by inhalation arm 3: Aclidininum bromide 400 μg twice daily by inhalation arm 4: Placebo twice-daily by inhalation arm 5: Formoterol 12 μg twice daily by inhalation

Interventions: intervention 1: Aclidinium bromide 100 μg bid intervention 2: Aclidinium bromide 200 μg bid intervention 3: Aclidininum bromide 400 μg bid intervention 4: Placebo intervention 5: Formoterol 12 μg bid
Intervention descriptions: intervention 1: Aclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days intervention 2: Aclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days intervention 3: Aclidinium bromide 400 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days intervention 4: Placebo via inhalation in the morning and evening for 7 days intervention 5: Formoterol 12 μg twice-daily via inhalation by Aerolizer® dry powder inhaler: 1 puff in the morning and evening for 7 days

Protocol document: