Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects With COPD

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema

In brief

The purpose of this study is to assess the bronchodilator effect and safety of multiple daily doses of arformoterol administered for 12 weeks as maintenance treatment in patients with COPD

Key facts

Study ID

NCT00064402

Run by

Sumitomo Pharma America, Inc.

People needed

741

Starts

2002-04-01

Expected to finish

2004-03-01

Last updated by the study team

2012-02-22

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be willing to comply with study procedures and visit schedule
• Are at least 35 years of age
• Female subjects >65 years of age must have a serum pregnancy test conducted at Visit 1 and confirmed negative prior to randomization
• Subjects of childbearing potential must be using an acceptable method of birth control. Female subjects who are considered not of childbearing potential must be: documented surgically sterile, OR postmenopausal.
• Have a primary diagnosis of COPD. Diagnosis can be made during the screening process.
• Have a minimum smoking history of 15 pack-years (pack-years = the number of cigarette packs per day times the number of years).
• Have a chest x-ray that is consistent with the diagnosis of COPD and taken <3 months prior to study start
• Able to complete all study questionnaires and logs reliably

You may not qualify if…

• Female subject who is pregnant or lactating
• Have participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another investigational drug study
• Subject whose schedule or travel prevents the completion of all required visits
• Are scheduled for in-patient hospitalization, including elective surgery during the trial
• Have life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days
• History of asthma or any chronic respiratory disease other than COPD (chronic bronchitis and/or emphysema)
• Have clinically significant cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol
• Have a history of cancer except non-melanomatous skin cancer
• Have a history of lung resection of more than one full lobe
• Requires continuous supplemental oxygen therapy.
• Has had a change in dose or type of any medications for COPD within 14 days prior to the screening visit
• Have a known sensitivity to arformoterol, ipratropium, salmeterol or albuterol or any of the excipients contained in any of these formulations
• Have a history of substance abuse or drug abuse within 12 months, or with a positive urine drug screen
• Are using any prescription drug for which concomitant beta-agonist administration is contraindicated (e.g., beta-blockers)

Where it is running

• Pulmonary Associates, PA — Phoenix, Arizona, United States
• Arizona Clinical Research Center, Inc. — Tucson, Arizona, United States
• Northern California Research Corp. — Fair Oaks, California, United States
• SARC Research Center — Fresno, California, United States
• California Research Medical Group, Inc. — Fullerton, California, United States
• Radiant Research-Irvine — Irvine, California, United States
• West Coast Clinical Trials — Newport Beach, California, United States
• Center for Clinical Trials, LLC — Paramount, California, United States
• Advances in Medicine — Rancho Mirage, California, United States
• Institute of Healthcare Assessment, Inc. — San Diego, California, United States
• San Jose Clinical Research — San Jose, California, United States
• Allergy & Asthma Medical Group of Diablo Valley, Inc. — Walnut Creek, California, United States
• Colorado Pulmonary Associates — Denver, Colorado, United States
• Northern Colorado Pulmonary Consultants, PC — Fort Collins, Colorado, United States
• Physicians Research Center, Inc. — Hartford, Connecticut, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Clinical Research of West Florida, Inc. — Clearwater, Florida, United States
• University Clinical Research, DeLand — DeLand, Florida, United States
• Mt. Sinai Medical Center — Miami Beach, Florida, United States
• Clinical Pharmacology Services — Tampa, Florida, United States
• Protocare Trial, Inc. — Austell, Georgia, United States
• Marietta Pulmonary Medicine — Marietta, Georgia, United States
• Office of Bradley Sakran, MD, PC — O'Fallon, Illinois, United States
• South Bend Clinic — South Bend, Indiana, United States
• Pulmonary & Sleep Associates of Jasper, PC — Jasper, Alabama, United States

Full record on ClinicalTrials.gov

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