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

Completed · Phase 4 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease, Bronchitis, Emphysema

In brief

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).

Key facts

Study ID

NCT00424528

Run by

Sumitomo Pharma America, Inc.

People needed

235

Starts

2006-12-01

Expected to finish

2007-10-01

Last updated by the study team

2012-06-04

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.

You may not qualify if…

• 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.

Where it is running

• Study site — Topeka, Kansas, United States
• Study site — Hazard, Kentucky, United States
• Study site — Madisonville, Kentucky, United States
• Study site — Marrero, Louisiana, United States
• Study site — Sunset, Louisiana, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Kalamazoo, Michigan, United States
• Study site — Saint Charles, Missouri, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Eugene, Oregon, United States
• Study site — Medford, Oregon, United States
• Study site — Portland, Oregon, United States
• Study site — East Providence, Rhode Island, United States
• Study site — Lincoln, Rhode Island, United States
• Study site — Columbia, South Carolina, United States
• Study site — Simpsonville, South Carolina, United States
• Study site — Spartanburg, South Carolina, United States
• Study site — Knoxville, Tennessee, United States
• Study site — Tacoma, Washington, United States
• Study site — Morgantown, West Virginia, United States
• Study site — Jasper, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — San Diego, California, United States

Full record on ClinicalTrials.gov

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