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

Completed · Phase 4 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT00571428

Run by

Sumitomo Pharma America, Inc.

People needed

33

Starts

2007-11-01

Expected to finish

2008-03-01

Last updated by the study team

2012-02-22

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Medford, Oregon, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Spartanburg, South Carolina, United States

Full record on ClinicalTrials.gov

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