Clinical trial NCT00064415: To Evaluate the Long-term Safety of (R,R)-Formoterol in Subjects With COPD
Official title: A Multicenter, Open-Label, Randomized, Active-Controlled, Parallel Group Chronic Safety Study of (R,R)-Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Emphysema
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2003-07-09
Enrollment: 799
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the long-term safety of arformoterol over a period of 12 months in subjects with COPD

Detailed description: This was a multicenter, open-label, randomized, active controlled, parallel group chronic safety study of arformoterol 50 mcg once daily over a period of 12 months in subjects with COPD. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility criteria: INCLUSION CRITERIA: In order to qualify for participation, subjects must meet the following criteria:

* Must give written informed consent prior to participation. Women of childbearing potential must also sign the Women of Childbearing Potential Addendum.
* Must be willing to comply with study procedures and visit schedule
* Male or female \>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: (1) documented surgically sterile, OR (2) postmenopausal
* Have a primary diagnosis of COPD, which may include components of chronic bronchitis and/or emphysema. 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)
* Medical Research Council (MRC) Dyspnea Scale Score \>2
* Have a baseline FEV1 \<65% of predicted normal value and \>0.70 L documented prior to randomization
* Have an FEV1/FVC ratio \<70% documented prior to randomization.
* Have a chest x-ray that is consistent with the diagnosis of COPD and taken \<3 months prior to Visit 1. If there is no chest x-ray taken 3 months prior to Visit 1, a chest x-ray will be performed prior to Visit 2.
* Be able to complete all study questionnaires and logs reliably

EXCLUSION CRITERIA: In order to qualify for participation, subjects must not meet any of the following criteria:

* Currently using disallowed medications or will be unable to complete the medication washout periods
* Female subject who is pregnant or lactating
* Have participated in an investigational drug study within 30 days prior to Visit 1 or who is currently participating in another investigational drug study
* Subject whose schedule or travel prevents the completion of all required visits
* Subject who is scheduled for in-patient hospitalization, including elective surgery (in-patient or out-patient) during the trial.
* Subject with life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to Visit 1
* Known history of asthma or any chronic respiratory disease (including a current history of sleep apnea) other than COPD (chronic bronchitis and/or emphysema).
* Subject with a blood eosinophil count \>5%
* Subject with clinically significant cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol
* History of cancer except non-melanomatous skin cancer
* History of lung resection of more than one full lobe
* Subject who requires continuous supplemental oxygen therapy. The use of supplemental oxygen, not to exceed 2 L/minute, at nighttime only and/or only during exercise is allowed.
* Have 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 (R,R)-formoterol, ipratropium, salmeterol or albuterol or any of the excipients contained in any of these formulations
* Have clinically significant abnormalities that may interfere with the metabolism or excretion of the study drug
* Have a history of substance abuse or drug abuse within 12 months of Visit 1 or with a positive urine drug screen at the screening visit
* Subject with clinically significant abnormal laboratory values
* Subject with clinically significant abnormal 12-lead ECG that may jeopardize the subject's ability to complete the study
* Subject using any prescription drug for which concomitant beta-agonist administration is contraindicated

Primary outcomes:
measure: Overall occurrence of adverse events
timeFrame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Secondary outcomes:
measure: Laboratory parameters
timeFrame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
measure: ECG parameters
timeFrame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
measure: 24-hour holter monitoring parameters
timeFrame: Weeks -1, 0, 13, 26, 39, 52
measure: Vital signs
timeFrame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
measure: Plasma arformoterol concentrations
timeFrame: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
measure: Physical examination findings
timeFrame: Weeks -1, 53
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Birmingham
country: United States
facility: Princeton Pulmonary Group, PC
state: Alabama
city: Jasper
country: United States
facility: Pulmonary & Sleep Associates of Jasper, PC
state: Alabama
city: Mobile
country: United States
facility: Pulmonary Associates of Mobile, P.C.
state: Alabama
city: Tucson
country: United States
facility: Arizona Clinical Research Center, Inc.
state: Arizona
city: Fair Oaks
country: United States
facility: Northern California Research Corp.
state: California
city: Fresno
country: United States
facility: SARC Research Center
state: California
city: Irvine
country: United States
facility: Irvine Center for Clinical Research
state: California
city: LaJolla
country: United States
facility: Scripps Clinic - Chest and Critical Care
state: California
city: Los Angeles
country: United States
facility: Torrance Clinical Research
state: California
city: Mission Hills
country: United States
facility: Facey Medical Center - Radiant Research
state: California
city: Murrieta
country: United States
facility: Office of Delmer Henninger, MD
state: California
city: Orange
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: Rancho Mirage
country: United States
facility: Advances in Medicine
state: California
city: Riverside
country: United States
facility: Inland Clinical Research, Inc.
state: California
city: San Diego
country: United States
facility: Institute of Healthcare Assessment, Inc.
state: California
city: San Diego
country: United States
facility: Wetlin Research Associates, Inc.
state: California
city: San Jose
country: United States
facility: San Jose Clinical Research, Inc.
state: California
city: Signal Hill
country: United States
facility: West Coast Clinical Trials
state: California
city: Walnut Creek
country: United States
facility: Allergy & Asthma Medical Group of Diablo Valley, Inc.
state: California
city: Ft. Collins
country: United States
facility: Northern Colorado Pulmonary Consultants, PC
state: Colorado
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: DeLand
country: United States
facility: University Clinical Research, DeLand
state: Florida
city: Melbourne
country: United States
facility: nTouch Research
state: Florida
city: St. Petersburg
country: United States
facility: nTouch Research
state: Florida
city: Tampa
country: United States
facility: USF Asthma, Allergy and Immunology
state: Florida
city: Tampa
country: United States
facility: AHS Medical Research, Inc.
state: Florida
city: Atlanta
country: United States
facility: New Horizon Health Research
state: Georgia
city: Austell
country: United States
facility: Protocare Trial, Inc.
state: Georgia
city: Decatur
country: United States
facility: nTouch Research
state: Georgia
city: Marietta
country: United States
facility: Marietta Pulmonary Medicine
state: Georgia
city: Roswell
country: United States
facility: North Point Pulmonary Associates
state: Georgia
city: Coeur d'Alene
country: United States
facility: Pulmonary Consultants
state: Idaho
city: Chicago
country: United States
facility: University of Chicago - Department of Medicine
state: Illinois
city: Normal
country: United States
facility: Sneeze, Wheeze and Itch, LLC
state: Illinois
city: Evansville
country: United States
facility: Medisphere Medical Research Center, LLC
state: Indiana
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Shawnee Mission
country: United States
facility: Heart of America Research Institute
state: Kansas
city: Lafayette
country: United States
facility: Bendel Medical Associates
state: Louisiana
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: Slidell
country: United States
facility: North Shore Research Associates
state: Louisiana
city: Bangor
country: United States
facility: Office of Paul A. Shapero, MD, PA
state: Maine
city: Ayer
country: United States
facility: Primary Care Cardiology Research, Inc.
state: Massachusetts
city: Taunton
country: United States
facility: Center for Clinical Research
state: Massachusetts
city: Ann Arbor
country: United States
facility: ClinSite, Inc.
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Lung Center
state: Minnesota
city: Saint Louis
country: United States
facility: MedEx HealthCare Research, Inc.
state: Missouri
city: St. Charles
country: United States
facility: Midwest Chest Consultants, PC
state: Missouri
city: St. Louis,
country: United States
facility: C.A.R.E Clinical Research
state: Missouri
city: Butte
country: United States
facility: Office of Keith Popovich, MD
state: Montana
city: Missoula
country: United States
facility: Montana Medical Research, LLC
state: Montana
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: Margate City
country: United States
facility: Atlantic Research Associates, Inc.
state: New Jersey
city: South Bound Brook
country: United States
facility: UrgentMed Family Practice Medical
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources - NM
state: New Mexico
city: Endwell
country: United States
facility: Endwell Family Physicians
state: New York
city: Ithaca
country: United States
facility: Asthma & Allergy Associates, PC
state: New York
city: New York City
country: United States
facility: N.Y. Pulmonary Associates
state: New York
city: Rochester
country: United States
facility: Ridgewood Medical Group
state: New York
city: Charlotte
country: United States
facility: Charlotte Lung and Health Center
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Medical Research
state: North Carolina
city: Fargo
country: United States
facility: Odyssey Research Services
state: North Dakota
city: Cincinnati
country: United States
facility: Community Research Management Associates, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: New Horizons Clinical Research, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: COR Clinical Research LLC
state: Oklahoma
city: Tulsa
country: United States
facility: Healthcare Research Consultants
state: Oklahoma
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon, PC
state: Oregon
city: Medford
country: United States
facility: Medford Medical Clinic, LLP
state: Oregon
city: Portland
country: United States
facility: Allergy Associates Research Center
state: Oregon
city: Allentown
country: United States
facility: Northeast Clinical Research Center, Inc.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Ridley Park
country: United States
facility: Consortium Clinical Research, Ltd.
state: Pennsylvania
city: East Providence
country: United States
facility: Safe Harbor Clinical Research
state: Rhode Island
city: Spartanburg
country: United States
facility: Spartanburg Pharmaceutical Research
state: South Carolina
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
city: Houston
country: United States
facility: S.W. Asthma Institute
state: Texas
city: Houston
country: United States
facility: Breath of Life Research Institute
state: Texas
city: San Antonio
country: United States
facility: Wellmed at Northern Hills
state: Texas
city: Chesapeake
country: United States
facility: Medsource, Inc.
state: Virginia
city: Fredericksburg
country: United States
facility: Pulmonary Associates of Fredericksburg, Inc.
state: Virginia
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond, Inc.
state: Virginia
city: Richmond
country: United States
facility: Commonwealth Clinical Research
state: Virginia
city: Richmond
country: United States
facility: Virginia Adult & Pediatric Allergy & Asthma, PC Research Office
state: Virginia
city: South Boston
country: United States
facility: Pulmonary Research Partners, Inc.
state: Virginia
city: Tacoma
country: United States
facility: Pulmonary Consultants, PLLC
state: Washington
city: Morgantown
country: United States
facility: Morgantown Pulmonary Associates
state: West Virginia
Study officials:
References: