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

21 de febrero de 2012 actualizado por: 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

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Actual)

799

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

35 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 1
Arformoterol tartrate 50 mcg QD
Droga: arformoterol
Arformoterol inhalation solution, 50 mcg QD
Otros nombres:
  • Brovana Inhalation Solution
  • (R,R)-Formoterol
Comparador activo: 2
Salmeterol 42 mcg BID
Droga: Salmeterol
Salmeterol MDI, 42 mcg BID
Otros nombres:
  • Serevent MDI
  • racemic formoterol

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Overall occurrence of adverse events
Periodo de tiempo: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Laboratory parameters
Periodo de tiempo: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
ECG parameters
Periodo de tiempo: 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
Periodo de tiempo: Weeks -1, 0, 13, 26, 39, 52
Weeks -1, 0, 13, 26, 39, 52
Vital signs
Periodo de tiempo: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Plasma arformoterol concentrations
Periodo de tiempo: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Physical examination findings
Periodo de tiempo: Weeks -1, 53
Weeks -1, 53

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Sunovion

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de junio de 2002

Finalización primaria (Actual)

1 de diciembre de 2004

Finalización del estudio (Actual)

1 de diciembre de 2004

Fechas de registro del estudio

Enviado por primera vez

8 de julio de 2003

Primero enviado que cumplió con los criterios de control de calidad

8 de julio de 2003

Publicado por primera vez (Estimar)

9 de julio de 2003

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

22 de febrero de 2012

Última actualización enviada que cumplió con los criterios de control de calidad

21 de febrero de 2012

Última verificación

1 de febrero de 2012

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 091-060

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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