Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects with Chronic Obstructive Pulmonary Disease (COPD).

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

Details

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

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.

Exclusion Criteria:

• Subjects who do not have a FEV1/forced vital capacity (FVC) ratio of ≤70% at Visit 1.

• Subjects who do not have a ³15 pack-year smoking history and a baseline breathlessness severity grade of ³2 (Modified Medical Research Council [MMRC] Dyspnea Scale Score) at Visit 1.