Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Chronic Bronchitis Emphysema
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 33
Healthy volunteers: no

Brief summary:
To evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4mL QD (two 15μg/2mL dosed in combination) over a 24-hour period compared to arformoterol tartrate inhalation solution 15μg/2 mL BID in subjects with COPD.

Detailed description:
This is a modified blind, randomized, multicenter, single dose two-way crossover study to assess the efficacy and safety of arformoterol 15μg BID versus arformoterol 30μg QD in subjects with COPD. Subject participation will last approximately three weeks and will include a screening visit, two 24-hour visits, and a follow up telephone call. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Arms:
arm 1: Arformoterol 15 microgram twice a day (BID) taken each morning and evening for one visit followed by Arformoterol 30 microgram once a day (QD) in the morning and placebo in the evening for the next visit. arm 2: Arformoterol 30 microgram once a day (QD) in the morning and placebo in the evening for one visit followed by Arformoterol 15 microgram twice a day (BID) in the morning and evening for the next visit.

Interventions: intervention 1: Arformoterol Tartrate Inhalation Solution intervention 2: Arformoterol Tartrate Inhalation Solution intervention 3: Placebo
Intervention descriptions: intervention 1: Nebulized arformoterol tartrate inhalation solution 15 microgram twice a day (BID) intervention 2: Nebulized arformoterol tartrate inhalation solution 30 microgram once a day (QD) intervention 3: Placebo inhalation solution (citrate buffered 0.9% saline solution) once a day

Protocol document: