NCT00691405

A Dose Ranging Study of Arformoterol Given Once Daily Compared to Arformoterol Given Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Double-blind, Randomized, Multicenter, Two-part Parallel-group, Dose-ranging Study of Twice-daily and Once-daily (R,R) Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

A dose ranging study to evaluate the safety, tolerability and efficacy of arformoterol (given once or twice a day) in subjects with COPD.

Detailed description

This study is a double-blind, repeat-dose, randomized, multicenter, two-part, parallel-group, dose-ranging study of arformoterol and placebo in the treatment of subjects with COPD. Approximately 215 subjects will be randomized in this study. Study participation will consist of a total of eight (8) study visits over approximately ten (10) weeks 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 5 mcg BID
DRUG	Arformoterol tartrate inhalation solution	Arformoterol 15 mcg BID
DRUG	Arformoterol tartrate inhalation solution	Arformoterol 25 mcg BID
DRUG	Placebo	Placebo inhalation solution BID
DRUG	Arformoterol tartrate inhalation solution	Arformoterol 15 mcg QD
DRUG	Arformoterol tartrate inhalation solution	Arformoterol 25 mcg QD
DRUG	Arformoterol tartrate inhalation solution	Arformoterol 50 mcg QD
DRUG	Placebo	Placebo inhalation solution QD

Timeline

• Start date: 2003-10-01
• Primary completion: 2004-05-01
• Completion: 2004-05-01
• First posted: 2008-06-05
• Last updated: 2012-02-22

Locations

31 sites across 1 country: United States