Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease (COPD) respiratory long-acting beta agonist (LABA)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 841
Healthy volunteers: no

Brief summary:
This is a multi-center study to evaluate the long-term safety of arformoterol 15 mcg twice daily (BID) in the treatment of subjects with moderate-to-severe COPD. Study participation will consist of a total of 6 visits over approximately 1 year.

Detailed description:
This is a multi-center, double-blind, randomized, placebo-controlled, parallel-group, outpatient, safety study to evaluate the long-term safety of arformoterol 15 mcg twice daily (BID) in the treatment of subjects with moderate-to-severe COPD. The administration of arformoterol in subjects with moderate to severe COPD will not result in a meaningfully greater incidence of respiratory death and COPD exacerbation -related hospitalizations compared to placebo (nebulized saline and non-long-acting beta2-agonist \[LABA\] COPD standard of care treatments). 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 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms. arm 2: Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.

Interventions: intervention 1: Arformoterol intervention 2: Placebo
Intervention descriptions: intervention 1: Arformoterol Tartrate Inhalation Solution 15 mcg twice daily (BID) for a duration of one year intervention 2: Placebo inhalation solution, twice daily (BID) for a duration of one year.

Protocol document: