An Open-Label, Randomized, Multiple Dose, 3-Way Crossover Study of Arformoterol Tartrate Inhalation Solution and Foradil® (Racemic Formoterol) in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)

NCT00685529 Phase 2 COMPLETED

The purpose of this study is to compare the blood levels of arformoterol tartrate inhalation solution to racemic formoterol in male and female subjects with mild to moderate Chronic Obstructive Pulmonary Disease (COPD).

Details

Lead sponsor	Sumitomo Pharma America, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	24
Start date	2005-04
Completion	2005-10

Conditions

• COPD

Interventions

• Racemic formoterol
• Arformoterol tartrate inhalation solution
• Racemic formoterol

Primary outcomes

• The primary endpoint for this study is exposure to (R,R)-formoterol, measured by the PK parameters AUC(0-τ) and Cmax — Treatment/Washout 1: Days 1, 12-18; T/W 2: 24, 35-40; T/W 3: 47, 58-64, EOT: 70

Countries

United States