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

NCT00064402 Phase 3 COMPLETED

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

Details

Lead sponsor	Sumitomo Pharma America, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	741
Start date	2002-04
Completion	2004-03

Conditions

• Chronic Obstructive Pulmonary Disease
• Chronic Bronchitis
• Emphysema

Interventions

• arformoterol tartrate inhalation solution
• arformoterol tartrate inhalation solution
• arformoterol tartrate inhalation solution
• Salmeterol
• Placebo

Primary outcomes

• percent change in trough FEV1 from study baseline to the end of the dosing interval (12 hours post-second dose for the BID treatment arms and 24 hours postdose for the QD treatment arm) over the double-blind period. — Weeks -2, 0, 3, 6, 9, 12

Countries

United States