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

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Emphysema
• Interventions: Drug: Salmeterol; Drug: arformoterol

• Registration Number: NCT00064415
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief 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.

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2003-07-08
• Study First Submitted QC: 2003-07-08
• Study First Posted: 2003-07-09
• Primary Completion: 2004-12
• Study Completion: 2004-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-21
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 799

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Salmeterol	Salmeterol 42 mcg BID
1	arformoterol	Arformoterol tartrate 50 mcg QD

Primary Outcome Measures

Name	Time	Method
Overall occurrence of adverse events	Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52

Secondary Outcome Measures

Name	Time	Method
ECG parameters	Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Vital signs	Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Physical examination findings	Weeks -1, 53
Plasma arformoterol concentrations	Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
24-hour holter monitoring parameters	Weeks -1, 0, 13, 26, 39, 52
Laboratory parameters	Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52

Trial Locations

Locations (88)

Pinnacle Research Group; 🇺🇸 Anniston, Alabama, United States

Princeton Pulmonary Group, PC; 🇺🇸 Birmingham, Alabama, United States

Pulmonary & Sleep Associates of Jasper, PC; 🇺🇸 Jasper, Alabama, United States

Pulmonary Associates of Mobile, P.C.; 🇺🇸 Mobile, Alabama, United States

Arizona Clinical Research Center, Inc.; 🇺🇸 Tucson, Arizona, United States

Northern California Research Corp.; 🇺🇸 Fair Oaks, California, United States

SARC Research Center; 🇺🇸 Fresno, California, United States

Irvine Center for Clinical Research; 🇺🇸 Irvine, California, United States

Scripps Clinic - Chest and Critical Care; 🇺🇸 LaJolla, California, United States

Torrance Clinical Research; 🇺🇸 Los Angeles, California, United States

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