NCT00685841

A Pivotal Study of the Safety and Effectiveness of Arformoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Double-Blind, Double-Dummy, Randomized, Placebo- and Active-Controlled, Multicenter, Parallel-Group Study of (R,R)-Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 717 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

A 12 week study to investigate the safety and effectiveness of arformoterol given twice daily compared to placebo in subjects with COPD.

Detailed description

This study is a double-blind, double-dummy, randomized, placebo- and active-controlled, multicenter, parallel-group study of adult subjects with a primary clinical diagnosis of COPD. Approximately 800 subjects were to be randomized in this study. Study participation consisted of a total of eight (8) study visits over approximately four (4) months for each subject. 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

• COPD

Interventions

Type	Name	Description
DRUG	Arformoterol tartrate inhalation solution	Arformoterol 50 mcg QD
DRUG	Arformoterol tartrate inhalation solution	Arformoterol 25 mcg BID
DRUG	Arformoterol tartrate inhalation solution	Arformoterol 15 mcg BID
DRUG	Salmeterol MDI	Salmeterol MDI 42 mcg BID
DRUG	Placebo	Placebo BID MDI

Timeline

• Start date: 2002-02-01
• Primary completion: 2003-06-01
• Completion: 2003-06-01
• First posted: 2008-05-28
• Last updated: 2012-11-02

Locations

52 sites across 1 country: United States