NCT00064402

Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects With 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: 741 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the bronchodilator effect and safety of multiple daily doses of arformoterol administered for 12 weeks as maintenance treatment in patients with COPD

Detailed description

This was a double-blind, double-dummy, randomized, placebo- and active-controlled, multicenter, parallel-group study of adult subjects with COPD. The study was double blinded through the use of both unit dose vial (UDV) and metered-dose inhaler (MDI) placebos, as appropriate. The primary efficacy analysis utilized the placebo control. Secondary analyses of the primary efficacy endpoint utilized the active control, and included comparisons between the placebo and active control. 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 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	Salmeterol MDI 42 mcg BID
DRUG	Placebo	Placebo BID

Timeline

• Start date: 2002-04-01
• Primary completion: 2004-03-01
• Completion: 2004-03-01
• First posted: 2003-07-09
• Last updated: 2012-02-22

Locations

65 sites across 1 country: United States