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

21. februar 2012 opdateret af: Sunovion

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

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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

799

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Anniston, Alabama, Forenede Stater, 36207
        • Pinnacle Research Group
      • Birmingham, Alabama, Forenede Stater, 35211
        • Princeton Pulmonary Group, PC
      • Jasper, Alabama, Forenede Stater, 35501
        • Pulmonary & Sleep Associates of Jasper, PC
      • Mobile, Alabama, Forenede Stater, 36608
        • Pulmonary Associates of Mobile, P.C.
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85712
        • Arizona Clinical Research Center, Inc.
    • California
      • Fair Oaks, California, Forenede Stater, 95628
        • Northern California Research Corp.
      • Fresno, California, Forenede Stater, 93720
        • SARC Research Center
      • Irvine, California, Forenede Stater, 92618
        • Irvine Center for Clinical Research
      • LaJolla, California, Forenede Stater, 92037
        • Scripps Clinic - Chest and Critical Care
      • Los Angeles, California, Forenede Stater, 90505
        • Torrance Clinical Research
      • Mission Hills, California, Forenede Stater, 91345
        • Facey Medical Center - Radiant Research
      • Murrieta, California, Forenede Stater, 92562
        • Office of Delmer Henninger, MD
      • Orange, California, Forenede Stater
        • Advanced Clinical Research Institute
      • Paramount, California, Forenede Stater, 90723
        • Center for Clinical Trials, LLC
      • Rancho Mirage, California, Forenede Stater, 92270
        • Advances in Medicine
      • Riverside, California, Forenede Stater, 92501
        • Inland Clinical Research, Inc.
      • San Diego, California, Forenede Stater, 92120
        • Institute of HealthCare Assessment, Inc.
      • San Diego, California, Forenede Stater, 92120
        • Wetlin Research Associates, Inc.
      • San Jose, California, Forenede Stater, 95128
        • San Jose Clinical Research, Inc.
      • Signal Hill, California, Forenede Stater, 90755
        • West Coast Clinical Trials
      • Walnut Creek, California, Forenede Stater, 94598
        • Allergy & Asthma Medical Group of Diablo Valley, Inc.
    • Colorado
      • Ft. Collins, Colorado, Forenede Stater, 80528
        • Northern Colorado Pulmonary Consultants, PC
    • Florida
      • Clearwater, Florida, Forenede Stater, 33765
        • Clinical Research of West Florida, Inc.
      • DeLand, Florida, Forenede Stater, 32720
        • University Clinical Research, DeLand
      • Melbourne, Florida, Forenede Stater, 32901
        • nTouch Research
      • St. Petersburg, Florida, Forenede Stater, 33710
        • nTouch Research
      • Tampa, Florida, Forenede Stater, 33613
        • USF Asthma, Allergy and Immunology
      • Tampa, Florida, Forenede Stater, 33615
        • AHS Medical Research, Inc.
    • Georgia
      • Atlanta, Georgia, Forenede Stater
        • New Horizon Health Research
      • Austell, Georgia, Forenede Stater, 30106
        • Protocare Trial, Inc.
      • Decatur, Georgia, Forenede Stater, 30033
        • nTouch Research
      • Marietta, Georgia, Forenede Stater, 30060
        • Marietta Pulmonary Medicine
      • Roswell, Georgia, Forenede Stater, 30076
        • North Point Pulmonary Associates
    • Idaho
      • Coeur d'Alene, Idaho, Forenede Stater, 83814
        • Pulmonary Consultants
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago - Department of Medicine
      • Normal, Illinois, Forenede Stater, 61761
        • Sneeze, Wheeze and Itch, LLC
    • Indiana
      • Evansville, Indiana, Forenede Stater, 47714
        • MediSphere Medical Research Center, LLC
      • South Bend, Indiana, Forenede Stater, 46617
        • South Bend Clinic
    • Kansas
      • Shawnee Mission, Kansas, Forenede Stater, 66216
        • Heart of America Research Institute
    • Louisiana
      • Lafayette, Louisiana, Forenede Stater, 70503
        • Bendel Medical Associates
      • New Orleans, Louisiana, Forenede Stater, 70119
        • New Orleans Center for Clinical Research
      • Slidell, Louisiana, Forenede Stater, 70461
        • North Shore Research Associates
    • Maine
      • Bangor, Maine, Forenede Stater, 04401
        • Office of Paul A. Shapero, MD, PA
    • Massachusetts
      • Ayer, Massachusetts, Forenede Stater, 01432
        • Primary Care Cardiology Research, Inc.
      • Taunton, Massachusetts, Forenede Stater, 02780
        • Center for Clinical Research
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • ClinSite, Inc.
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Minnesota Lung Center
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63108
        • Medex Healthcare Research, Inc.
      • St. Charles, Missouri, Forenede Stater, 63301-2847
        • Midwest Chest Consultants, PC
      • St. Louis,, Missouri, Forenede Stater, 63122
        • C.A.R.E Clinical Research
    • Montana
      • Butte, Montana, Forenede Stater, 59701
        • Office of Keith Popovich, MD
      • Missoula, Montana, Forenede Stater, 59804
        • Montana Medical Research, LLC
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89104
        • Clinical Research Center of Nevada
      • Las Vegas, Nevada, Forenede Stater, 89119
        • Advanced Biomedical Research of America
    • New Jersey
      • Margate City, New Jersey, Forenede Stater, 08402
        • Atlantic Research Associates, Inc.
      • South Bound Brook, New Jersey, Forenede Stater, 08880
        • UrgentMed Family Practice Medical
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87108
        • Lovelace Scientific Resources - NM
    • New York
      • Endwell, New York, Forenede Stater, 13760
        • Endwell Family Physicians
      • Ithaca, New York, Forenede Stater, 14850
        • Asthma & Allergy Associates, PC
      • New York City, New York, Forenede Stater, 10016
        • N.Y. Pulmonary Associates
      • Rochester, New York, Forenede Stater, 14626
        • Ridgewood Medical Group
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28207
        • Charlotte Lung and Health Center
      • Raleigh, North Carolina, Forenede Stater
        • North Carolina Clinical Research
      • Wilmington, North Carolina, Forenede Stater, 28412
        • New Hanover Medical Research
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58104
        • Odyssey Research Services
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45241
        • New Horizons Clinical Research, Inc.
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Community Research Management Associates, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73103
        • COR Clinical Research LLC
      • Tulsa, Oklahoma, Forenede Stater, 74135
        • Healthcare Research Consultants
    • Oregon
      • Medford, Oregon, Forenede Stater, 97504
        • Clinical Research Institute of Southern Oregon, PC
      • Medford, Oregon, Forenede Stater, 97504
        • Medford Medical Clinic, LLP
      • Portland, Oregon, Forenede Stater, 97213
        • Allergy Associates Research Center
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18104
        • Northeast Clinical Research Center, Inc.
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh
      • Ridley Park, Pennsylvania, Forenede Stater, 19078
        • Consortium Clinical Research, Ltd.
    • Rhode Island
      • East Providence, Rhode Island, Forenede Stater, 02914
        • Safe Harbor Clinical Research
    • South Carolina
      • Spartanburg, South Carolina, Forenede Stater, 29307
        • Spartanburg Pharmaceutical Research
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37920
        • Volunteer Research Group
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Ben Taub General Hospital
      • Houston, Texas, Forenede Stater, 77084
        • Breath of Life Research Institute
      • Houston, Texas, Forenede Stater, 77074
        • S.W. Asthma Institute
      • San Antonio, Texas, Forenede Stater, 78217
        • Wellmed at Northern Hills
    • Virginia
      • Chesapeake, Virginia, Forenede Stater, 23321
        • MedSource, Inc.
      • Fredericksburg, Virginia, Forenede Stater, 22401
        • Pulmonary Associates of Fredericksburg, Inc.
      • Richmond, Virginia, Forenede Stater, 23225
        • Pulmonary Associates of Richmond, Inc.
      • Richmond, Virginia, Forenede Stater, 23226
        • Commonwealth Clinical Research
      • Richmond, Virginia, Forenede Stater, 23229
        • Virginia Adult & Pediatric Allergy & Asthma, PC Research Office
      • South Boston, Virginia, Forenede Stater, 24592
        • Pulmonary Research Partners, Inc.
    • Washington
      • Tacoma, Washington, Forenede Stater, 98405
        • Pulmonary Consultants, PLLC
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26505
        • Morgantown Pulmonary Associates

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

35 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Arformoterol tartrate 50 mcg QD
Medicin: arformoterol
Arformoterol inhalation solution, 50 mcg QD
Andre navne:
  • Brovana Inhalation Solution
  • (R,R)-Formoterol
Aktiv komparator: 2
Salmeterol 42 mcg BID
Medicin: Salmeterol
Salmeterol MDI, 42 mcg BID
Andre navne:
  • Serevent MDI
  • racemic formoterol

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Overall occurrence of adverse events
Tidsramme: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52

Sekundære resultatmål

Resultatmål
Tidsramme
Laboratory parameters
Tidsramme: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
ECG parameters
Tidsramme: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
24-hour holter monitoring parameters
Tidsramme: Weeks -1, 0, 13, 26, 39, 52
Weeks -1, 0, 13, 26, 39, 52
Vital signs
Tidsramme: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Plasma arformoterol concentrations
Tidsramme: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Physical examination findings
Tidsramme: Weeks -1, 53
Weeks -1, 53

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sunovion

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2002

Primær færdiggørelse (Faktiske)

1. december 2004

Studieafslutning (Faktiske)

1. december 2004

Datoer for studieregistrering

Først indsendt

8. juli 2003

Først indsendt, der opfyldte QC-kriterier

8. juli 2003

Først opslået (Skøn)

9. juli 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. februar 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. februar 2012

Sidst verificeret

1. februar 2012

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 091-060

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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