To Evaluate the Long-term Safety of (R,R)-Formoterol in Subjects With COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064415
• Other study ID #: 091-060
• Status: Completed
• Phase: Phase 3
• First received: July 8, 2003
• Last updated: February 21, 2012
• Start date: June 2002
• Est. completion date: December 2004

Study information

• Verified date: February 2012
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 799
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• Chronic Obstructive Pulmonary Disease
• Emphysema
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• arformoterol
Arformoterol inhalation solution, 50 mcg QD
• Salmeterol
Salmeterol MDI, 42 mcg BID

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall occurrence of adverse events		Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52	Yes
Secondary	Laboratory parameters		Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52	Yes
Secondary	ECG parameters		Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52	Yes
Secondary	24-hour holter monitoring parameters		Weeks -1, 0, 13, 26, 39, 52	Yes
Secondary	Vital signs		Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52	Yes
Secondary	Plasma arformoterol concentrations		Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52	No
Secondary	Physical examination findings		Weeks -1, 53	No