NCT00250679

Safety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease

Multicenter, Double-Blind, Double-Dummy, Randomized, Active-Controlled, Parallel Group Long-Term Safety Study of 15 μg and 25 μg Arformoterol Tartrate Inhalation Solution BID in Subjects With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 443 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the long-term safety and monitor the long-term efficacy of arformoterol over a period of 6 months in subjects with chronic obstructive pulmonary disease (COPD).

Detailed description

This is a double-blind, double-dummy, multicenter, randomized, active-controlled, parallel group, outpatient, safety study to evaluate the long term safety of arformoterol in the treatment of subjects with COPD. Study participation will be over approximately 6 months. 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.

Conditions

• Chronic Obstructive Pulmonary Disease
• Bronchitis
• Emphysema

Interventions

Type	Name	Description
DRUG	Arformoterol tartrate inhalation solution	Arformoterol 15 ųg BID by nebulization
DRUG	Arformoterol 25 ųg BID	Arformoterol 25 ųg BID by nebulization
DRUG	Formoterol 12 ųg BID	Formoterol fumarate 12 ųg BID via aerolizer/DPI
DRUG	Placebo	Placebo nebule or placebo aerolizer

Timeline

• Start date: 2005-10-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2005-11-08
• Last updated: 2012-06-04
• Results posted: 2009-02-19

Locations

60 sites across 1 country: United States