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

21 febbraio 2012 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

799

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

35 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 1
Arformoterol tartrate 50 mcg QD
Droga: arformoterol
Arformoterol inhalation solution, 50 mcg QD
Altri nomi:
  • Brovana Inhalation Solution
  • (R,R)-Formoterol
Comparatore attivo: 2
Salmeterol 42 mcg BID
Droga: Salmeterol
Salmeterol MDI, 42 mcg BID
Altri nomi:
  • Serevent MDI
  • racemic formoterol

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Overall occurrence of adverse events
Lasso di tempo: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Laboratory parameters
Lasso di tempo: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
ECG parameters
Lasso di tempo: 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
Lasso di tempo: Weeks -1, 0, 13, 26, 39, 52
Weeks -1, 0, 13, 26, 39, 52
Vital signs
Lasso di tempo: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Plasma arformoterol concentrations
Lasso di tempo: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Physical examination findings
Lasso di tempo: Weeks -1, 53
Weeks -1, 53

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sunovion

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2002

Completamento primario (Effettivo)

1 dicembre 2004

Completamento dello studio (Effettivo)

1 dicembre 2004

Date di iscrizione allo studio

Primo inviato

8 luglio 2003

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2003

Primo Inserito (Stima)

9 luglio 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

22 febbraio 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 febbraio 2012

Ultimo verificato

1 febbraio 2012

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 091-060

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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