NCT00571428

Efficacy Safety Study of Arformoterol QD Dosing Versus BID Dosing in COPD

Modified-blind, Randomized, Multicenter, Single Dose, Two-way Crossover Study of Arformoterol Tartrate Inhalation Solution 15 Micrograms Twice A Day Versus 30 Micrograms Once A Day in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4mL QD (two 15μg/2mL dosed in combination) over a 24-hour period compared to arformoterol tartrate inhalation solution 15μg/2 mL BID in subjects with COPD.

Detailed description

This is a modified blind, randomized, multicenter, single dose two-way crossover study to assess the efficacy and safety of arformoterol 15μg BID versus arformoterol 30μg QD in subjects with COPD. Subject participation will last approximately three weeks and will include a screening visit, two 24-hour visits, and a follow up telephone call. 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

Interventions

Type	Name	Description
DRUG	Arformoterol Tartrate Inhalation Solution	Nebulized arformoterol tartrate inhalation solution 15 microgram twice a day (BID)
DRUG	Arformoterol Tartrate Inhalation Solution	Nebulized arformoterol tartrate inhalation solution 30 microgram once a day (QD)
DRUG	Placebo	Placebo inhalation solution (citrate buffered 0.9% saline solution) once a day

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2007-12-12
• Last updated: 2012-02-22
• Results posted: 2009-07-02

Locations

4 sites across 1 country: United States