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

21. februar 2012 oppdatert av: 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

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

799

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

35 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 1
Arformoterol tartrate 50 mcg QD
Legemiddel: arformoterol
Arformoterol inhalation solution, 50 mcg QD
Andre navn:
  • Brovana Inhalation Solution
  • (R,R)-Formoterol
Aktiv komparator: 2
Salmeterol 42 mcg BID
Legemiddel: Salmeterol
Salmeterol MDI, 42 mcg BID
Andre navn:
  • Serevent MDI
  • racemic formoterol

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sunovion

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2002

Primær fullføring (Faktiske)

1. desember 2004

Studiet fullført (Faktiske)

1. desember 2004

Datoer for studieregistrering

Først innsendt

8. juli 2003

Først innsendt som oppfylte QC-kriteriene

8. juli 2003

Først lagt ut (Anslag)

9. juli 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

22. februar 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. februar 2012

Sist bekreftet

1. februar 2012

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 091-060

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på arformoterol

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Sponsorer og samarbeidspartnere

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Legemiddelintervensjoner

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Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

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