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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Formoterol Fumarate; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Male and female subjects must be at least 45 years old at the time of consent.

• Subjects must have a pre-established primary clinical diagnosis of COPD.

• Subjects must have a baseline FEV1 of ≤ 65% of predicted normal value at Visit 1.

• Subjects must have a FEV1 ≥ 0.70L at Visit 1.

• Subjects must have a FEV1/forced vital capacity (FVC) ratio of ≤ 70% at Visit 1.

Exclusion Criteria:

• Subjects who do not have a 15 pack-year smoking history and a baseline breathlessness severity grade of 2 (as measured by the Modified Medical Research Council [MMRC] Dyspnea Scale Score) at Screening.

• Subjects with life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to Visit