NCT00064415

To Evaluate the Long-term Safety of (R,R)-Formoterol in Subjects With COPD

A Multicenter, Open-Label, Randomized, Active-Controlled, Parallel Group Chronic Safety Study of (R,R)-Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 799 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the long-term safety of arformoterol over a period of 12 months in subjects with COPD

Detailed description

This was a multicenter, open-label, randomized, active controlled, parallel group chronic safety study of arformoterol 50 mcg once daily over a period of 12 months in subjects with COPD. 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
• Chronic Bronchitis
• Emphysema

Interventions

Type	Name	Description
DRUG	arformoterol	Arformoterol inhalation solution, 50 mcg QD
DRUG	Salmeterol	Salmeterol MDI, 42 mcg BID

Timeline

• Start date: 2002-06-01
• Primary completion: 2004-12-01
• Completion: 2004-12-01
• First posted: 2003-07-09
• Last updated: 2012-02-22

Locations

90 sites across 1 country: United States