Safety Study of Arformoterol Tartrate Inhalation Solution in Chronic Obstructive Pulmonary Disease (COPD) Subjects

Last updated: September 12, 2013
Sponsor: Sunovion
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT00909779
091-080
  • Ages > 40
  • All Genders

Study Summary

This is a multi-center study to evaluate the long-term safety of arformoterol 15 mcg twice daily (BID) in the treatment of subjects with moderate-to-severe COPD. Study participation will consist of a total of 6 visits over approximately 1 year.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject must give written informed consent, including privacy authorization as well asadherence to concomitant medication withholding periods, prior to participation.

  • Females considered not of childbearing potential must be surgically sterile (totalhysterectomy, bilateral salpingo oophorectomy, or tubal ligation) or post-menopausal,which is defined as a complete cessation of menstruation for at least 1 year.

  • Male and female subjects must be at least 40 years old at the time of consent.

  • Subjects must have a pre-established, documented primary clinical diagnosis ofnon-asthmatic COPD or are referred for diagnosis of non-asthmatic COPD.

  • Subjects must have a baseline FEV1 of ≤50% predicted volume at Visits 1 and 2 (pre-dose).

  • Subjects must have a FEV1 >0.50 L at either Visit 1 or 2 (pre-dose).

  • Subject's respiratory status must be clinically stable.

  • Subjects must have a FEV1/forced vital capacity (FVC) ratio of ≤70% at either Visit 1or 2 (pre-dose).

  • Subjects must have had at least 1 COPD exacerbation within the last year (defined asinitiation or an increase in the dose of oral steroids or antibiotics for thetreatment of COPD).

  • Subjects must have a ≥15 pack-year smoking history and a baseline breathlessnessseverity grade of ≥2 (Modified Medical Research Council [MMRC] Dyspnea Scale Score) atVisit 2.

  • Female subjects ≤65 years of age must have a negative serum pregnancy test conductedat Visit 1 prior to randomization. Females of childbearing potential must be using anacceptable method of birth control.

  • Subjects' overall health must be sufficiently stable to complete the studyrequirements based on the screening physical examination (defined as the absence ofany clinically relevant abnormalities), medical history, 12-lead ECG, and clinicallaboratory values (hematology, serum chemistry and urinalysis), and vital signs (heartrate, respiratory rate, and blood pressure) that have been conducted within 30 days ofVisit 2 (randomization). If any of the hematology, chemistry, or urinalysis resultsare not within the laboratory's reference range, then the subject can be included onlyif the investigator judges the deviations to be not clinically significant.

  • Subjects must have a minimum blood pressure of 105/60 mmHg and a minimum resting pulseof 50 bpm at Screening Visit 1. Subjects who do not meet these criteria at ScreeningVisit 1 must meet the criteria on the first day of dosing (Day 1) in order to beeligible for the study. Subjects with a medical condition which causes low bloodpressure or low heart rate, but, in the opinion of the Principal Investigator ordesignee the medical condition could resolve, may be rescreened when the condition isresolved.

  • Subjects must be willing and able to complete all study questionnaires and logsreliably.

  • Subjects must be willing and able to comply with study procedures and visit schedule.

  • Subjects must have sufficient understanding of English to complete all questionnairesand logs.

Exclusion

Exclusion Criteria:

  • Female subjects who are pregnant or lactating.

  • Subjects with a history of asthma, with the exception of asthma diagnosed inchildhood.

  • Subjects with a blood eosinophil count >5% of total white blood cell count.

  • Subjects with a febrile illness within 3 days before Screening.

  • Subjects with a malignant neoplasm other than non melanomatous basal cell skin cancer.Subjects with a history of malignancy who have been cancer free for 5 years or moremay be enrolled.

  • Subjects who are currently using disallowed medications or will be unable to completethe medication washout periods. Subjects taking a prohibited concurrent medicationwhich requires a washout of >30 days may be rescreened when the washout of theprohibited concurrent medication has been met.

  • Subjects with life threatening/unstable respiratory status, including upper or lowerrespiratory tract infection, within the previous 30 days prior to screening.

  • Subjects who have had a change in dose or type of any medications for COPD within 2weeks prior to the screening visit. Subjects not on a stable dose of COPD medicationsmay be rescreened after being on a stable dose for at least 14 days

  • Subjects with a chest x ray taken ≤3 months prior to screening that suggests adiagnosis other than COPD (eg, diagnostic of pneumonia, other infection, atelectasis,or pneumothorax or other active/ongoing pulmonary conditions). If there is no chest xray taken ≤3 months prior to screening, or if recent results are unavailable forreview, a chest x ray must be performed prior to visit 2. Subjects with a medicalcondition that caused the abnormal finding, but, in the opinion of the PrincipalInvestigator or designee the medical condition could resolve, may be rescreened whenthe condition is resolved

  • Subjects with a positive urine drug test during screening.

  • Subjects with a known history of alcohol abuse may be enrolled in the study if thesubject's current alcohol use does not exceed more than 3 alcoholic beverages per day.

  • Subjects whose schedule or travel prevents the completion of all required visits.

  • Subjects who are scheduled for inpatient hospitalization or elective surgery (inpatient or outpatient) during the trial. Subjects may be rescreened when thecondition is resolved.

  • Subjects have participated in an investigational drug study and/or any COPDinterventional trial within 30 days prior to screening or who are currentlyparticipating in another investigational drug study or COPD interventional trial.

  • Subjects with a history of allergic reaction to the study medication or any componentsof the study medications.

  • Subjects who are study site staff members or relatives of study site staff membersdirectly involved in this study.

  • Subjects with clinically significant cardiac, (Functional Class III and IV; ObjectiveClass C and D by New York Heart Association [NYHA] Functional Classification),hepatic,renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorderthat may interfere with successful completion of this protocol.

Study Design

Total Participants: 841
Study Start date:
June 01, 2009
Estimated Completion Date:
June 30, 2012

Study Description

This is a multi-center, double-blind, randomized, placebo-controlled, parallel-group, outpatient, safety study to evaluate the long-term safety of arformoterol 15 mcg twice daily (BID) in the treatment of subjects with moderate-to-severe COPD. The administration of arformoterol in subjects with moderate to severe COPD will not result in a meaningfully greater incidence of respiratory death and COPD exacerbation -related hospitalizations compared to placebo (nebulized saline and non-long-acting beta2-agonist [LABA] COPD standard of care treatments). 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.

Connect with a study center

  • Alabama Clinical Therapeutic, LLC

    Birmingham, Alabama 35235
    United States

    Site Not Available

  • Jefferson Clinic

    Birmingham, Alabama 25233
    United States

    Site Not Available

  • Achieve Clinical Research

    Brimingham, Alabama 35209
    United States

    Site Not Available

  • Jasper Summit Research, LLC

    Jasper, Alabama 35501
    United States

    Site Not Available

  • Chest Critical Care Consultants

    Anaheim, California 92801
    United States

    Site Not Available

  • California Research Medical Group

    Fullerton, California 92835
    United States

    Site Not Available

  • Integrated Research Group

    Riverside, California 92506
    United States

    Site Not Available

  • Quality Control Research Inc.

    Roseville, California 95661
    United States

    Site Not Available

  • Sockolov and Sockolov APC

    Sacramento, California 95825
    United States

    Site Not Available

  • Centers for Clinical Trials of Sacremento

    Sacremento, California 95823
    United States

    Site Not Available

  • Institute of HealthCare Assessment, Inc.

    San Diego, California 92120
    United States

    Site Not Available

  • National Jewish Health

    Denver, Colorado 80206
    United States

    Site Not Available

  • Southeast Clinical Research

    Chiefland, Florida 32626
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Tampa Bay Medical Research Inc.

    Clearwater, Florida 33761
    United States

    Site Not Available

  • Avail Clinical Research

    DeLand, Florida 32720
    United States

    Site Not Available

  • The Lung Clinic, P.A.

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • DCT

    Orlando, Florida 32806
    United States

    Site Not Available

  • Clinical Research of West Florida

    Tampa, Florida 33603
    United States

    Site Not Available

  • Canton, Georgia 30114
    United States

    Site Not Available

  • Southeast Regional Research Group

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Atlanta Pharmaceutical Research

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Wellstar Marietta Pulmonary Medicine

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Southeast Regional Research Group

    Rincon, Georgia 31326
    United States

    Site Not Available

  • Medisphere Medical Research Center

    Evansville, Indiana 47714
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Kentucky Lung Clinic

    Hazard, Kentucky 41701
    United States

    Site Not Available

  • Bendel Medical Research Center, LLC

    Lafayette, Louisiana 70503
    United States

    Site Not Available

  • ClinSite LLC

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Clinical Research Institute Inc.

    Minneapolis, Minnesota 55402
    United States

    Site Not Available

  • Midwest Chest Consultants

    St. Charles, Missouri 63301
    United States

    Site Not Available

  • C.A.R.E. Clinical Research

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Comprehensive Clinical Research

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Delaware Valley Clinical Research

    Cherry Hill, New Jersey 08003
    United States

    Site Not Available

  • New York Pulmonary and Clinical Care Associates, PC

    New York, New York 10016
    United States

    Site Not Available

  • ENT & Allergy Associates

    Newburgh, New York 12550
    United States

    Site Not Available

  • AAIR Research Center

    Rochester, New York 14618
    United States

    Site Not Available

  • Rochester Clinical Research

    Rochester, New York 14609
    United States

    Site Not Available

  • American Health Research Inc.

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Piedmont Medical Research

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • DayStar Clinical Research, Inc.

    Akron, Ohio 44313
    United States

    Site Not Available

  • Bernstein Clinical Research Center

    Cincinnati, Ohio 45231
    United States

    Site Not Available

  • Clinical Research Institute of Southern Oregon, PC

    Medford, Oregon 97504
    United States

    Site Not Available

  • Allergy Associates Research Center

    Portland, Oregon 97216
    United States

    Site Not Available

  • Arcuri Clinical Research, LLC

    Philadelphia, Pennsylvania 19142
    United States

    Site Not Available

  • Biomedical Research Alliance at Hypertension and Nephrology

    Pawtucket, Rhode Island 02860
    United States

    Site Not Available

  • Omega Medical Research

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • Lowcountry Lung & Critical Care, PA

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Neem Research Group, Inc.

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • Gaffney Pharmaceutical Research

    Gaffney, South Carolina 29340
    United States

    Site Not Available

  • Greenville Pharmaceutical Research

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Upstate Pharmaceutical Research

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Mountain View Clinical Research, Inc.

    Greer, South Carolina 29651
    United States

    Site Not Available

  • S. Carolina Pharmaceutical Research

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • CU Pharmaceutical Research

    Union, South Carolina 29379
    United States

    Site Not Available

  • Allergy Associates

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Volunteer Research Group

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • DCT

    Arlington, Texas 76014
    United States

    Site Not Available

  • Baylor College of Medicine, Clinical Studies Unit, Ben Taub General Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • VAMC

    Houston, Texas 77030
    United States

    Site Not Available

  • Kingwood Research Institute, LLC

    Kingwood, Texas 77339
    United States

    Site Not Available

  • Diagnostics Research Group

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Physician PrimeCare Research

    San Antonio, Texas 78212
    United States

    Site Not Available

  • DCT

    Sugar Land, Texas 77878
    United States

    Site Not Available

  • SouthEast Research Institute

    Webster, Texas 77598
    United States

    Site Not Available

  • National Clinical Resources, Inc.

    Provo, Utah 84604
    United States

    Site Not Available

  • Utah Clinical Trials LLC

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Charlottesville Medical Research Inc.

    Charlottesville, Virginia 22911
    United States

    Site Not Available

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Site Not Available

  • Dominion Medical Associates

    Richmond, Virginia 23219
    United States

    Site Not Available

  • Pulmonary Associates of Richmond Inc.

    Richmond, Virginia 23225
    United States

    Site Not Available

  • Pulmonary Associates of Richmond, Inc.

    Richmond, Virginia 23229
    United States

    Site Not Available

  • Pulmonary Consultants, PLLC

    Tacoma, Washington 98405
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.