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Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects With COPD

21. februar 2012 opdateret af: Sunovion

A Double-Blind, Double-Dummy, Randomized, Placebo- and Active-Controlled, Multicenter, Parallel-Group Study of (R,R)-Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease

The purpose of this study is to assess the bronchodilator effect and safety of multiple daily doses of arformoterol administered for 12 weeks as maintenance treatment in patients with COPD

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This was a double-blind, double-dummy, randomized, placebo- and active-controlled, multicenter, parallel-group study of adult subjects with COPD. The study was double blinded through the use of both unit dose vial (UDV) and metered-dose inhaler (MDI) placebos, as appropriate. The primary efficacy analysis utilized the placebo control. Secondary analyses of the primary efficacy endpoint utilized the active control, and included comparisons between the placebo and active control. 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)

741

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
      • Jasper, Alabama, Forenede Stater, 35501
        • Pulmonary & Sleep Associates of Jasper, PC
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
        • Pulmonary Associates, PA
      • 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
      • Fullerton, California, Forenede Stater, 92835
        • California Research Medical Group, Inc.
      • Irvine, California, Forenede Stater, 92618
        • Radiant Research-Irvine
      • Newport Beach, California, Forenede Stater
        • West Coast Clinical Trials
      • Paramount, California, Forenede Stater, 90723
        • Center for Clinical Trials, LLC
      • Rancho Mirage, California, Forenede Stater, 92270
        • Advances in Medicine
      • San Diego, California, Forenede Stater, 92120
        • Institute of HealthCare Assessment, Inc.
      • San Jose, California, Forenede Stater
        • San Jose Clinical Research
      • Walnut Creek, California, Forenede Stater, 94598
        • Allergy & Asthma Medical Group of Diablo Valley, Inc.
    • Colorado
      • Denver, Colorado, Forenede Stater, 80218
        • Colorado Pulmonary Associates
      • Fort Collins, Colorado, Forenede Stater
        • Northern Colorado Pulmonary Consultants, PC
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06106
        • Physicians Research Center, Inc.
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater
        • Washington Hospital Center
    • Florida
      • Clearwater, Florida, Forenede Stater, 33765
        • Clinical Research of West Florida, Inc.
      • DeLand, Florida, Forenede Stater, 32720
        • University Clinical Research, DeLand
      • Miami Beach, Florida, Forenede Stater, 33140
        • Mt. Sinai Medical Center
      • Tampa, Florida, Forenede Stater, 33617
        • Clinical Pharmacology Services
    • Georgia
      • Austell, Georgia, Forenede Stater, 30106
        • Protocare Trial, Inc.
      • Marietta, Georgia, Forenede Stater, 30060
        • Marietta Pulmonary Medicine
    • Illinois
      • O'Fallon, Illinois, Forenede Stater, 62269
        • Office of Bradley Sakran, MD, PC
    • Indiana
      • South Bend, Indiana, Forenede Stater, 46617
        • South Bend Clinic
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40215
        • Family Allergy & Asthma Research Institute
      • Somerset, Kentucky, Forenede Stater
        • Cumberland Lung and Sleep Specialists
    • Louisiana
      • Lafayette, Louisiana, Forenede Stater, 70503
        • Bendel Medical Associates/Research
      • New Orleans, Louisiana, Forenede Stater
        • New Orleans Center for Clinical Research
      • New Orleans, Louisiana, Forenede Stater, 70119
        • New Orleans Center for Clinical Research
      • New Orleans, Louisiana, Forenede Stater, 70115
        • Best Clinical Trials, LLC
      • Slidell, Louisiana, Forenede Stater, 70461
        • North Shore Research Associates
      • Sunset, Louisiana, Forenede Stater, 70584
        • Sunset Medical Research
    • Maryland
      • Baltimore, Maryland, Forenede Stater
        • University of Maryland-Airways Research Center
      • Wheaton, Maryland, Forenede Stater
        • Institute of Asthma and Allergy
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02135
        • Pro-Medica Clinical Research Center
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • ClinSite, Inc.
    • 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
        • Office of Keith Popovich, MD
      • Missoula, Montana, Forenede Stater
        • Montana Medical Research, LLC
    • Nebraska
      • Omaha, Nebraska, Forenede Stater
        • VA Medical Center
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89119
        • Advanced Biomedical Research of America
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • Pulmonary Medicine
      • Charlotte, North Carolina, Forenede Stater, 28207
        • Charlotte Lung and Health Center
      • Statesville, North Carolina, Forenede Stater, 28625
        • Carolina Pharmaceutical Research, Inc.
      • Wilmington, North Carolina, Forenede Stater, 28412
        • New Hanover Medical Research
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45241
        • New Horizons Clinical Research, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73103
        • COR Clinical Research LLC
    • Oregon
      • Portland, Oregon, Forenede Stater, 97213
        • Allergy Associates Research Center
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18104
        • Northeast Clinical Research Centers, Inc.
      • Altoona, Pennsylvania, Forenede Stater, 16602
        • Keystone Clinical Solutions
      • Philadelphia, Pennsylvania, Forenede Stater, 19146
        • Philadelphia Health Associates - Adult Medicine
      • 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, 77084
        • Breath of Life Research Institute
      • New Braunfels, Texas, Forenede Stater, 78130
        • Central Texas Health Research
      • San Antonio, Texas, Forenede Stater, 78229
        • Sylvana Research Associates
    • Virginia
      • Fredericksburg, Virginia, Forenede Stater, 22401
        • Pulmonary Associates of Fredericksburg, Inc.
      • Richmond, Virginia, Forenede Stater, 23225
        • Pulmonary Associates of Richmond, Inc.
    • Washington
      • Bellingham, Washington, Forenede Stater, 98225
        • Bellingham Asthma, Allergy & Immunology Clinic
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • University of Wisconsin-Medical School

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:

  • Be willing to comply with study procedures and visit schedule
  • Are at least 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: documented surgically sterile, OR postmenopausal.
  • Have a primary diagnosis of COPD. 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).
  • Have a chest x-ray that is consistent with the diagnosis of COPD and taken <3 months prior to study start
  • Able to complete all study questionnaires and logs reliably

Exclusion Criteria:

  • Female subject who is pregnant or lactating
  • Have participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another investigational drug study
  • Subject whose schedule or travel prevents the completion of all required visits
  • Are scheduled for in-patient hospitalization, including elective surgery during the trial
  • Have life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days
  • History of asthma or any chronic respiratory disease other than COPD (chronic bronchitis and/or emphysema)
  • Have clinically significant cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol
  • Have a history of cancer except non-melanomatous skin cancer
  • Have a history of lung resection of more than one full lobe
  • Requires continuous supplemental oxygen therapy.
  • Has 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 arformoterol, ipratropium, salmeterol or albuterol or any of the excipients contained in any of these formulations
  • Have a history of substance abuse or drug abuse within 12 months, or with a positive urine drug screen
  • Are using any prescription drug for which concomitant beta-agonist administration is contraindicated (e.g., beta-blockers)

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Arformoterol 50 mcg QD and placebo MDI
Medicin: arformoterol tartrate inhalation solution
arformoterol 50 mcg QD
Andre navne:
  • (R,R)-formoterol
Medicin: arformoterol tartrate inhalation solution
arformoterol 25 mcg BID
Andre navne:
  • (R,R)-formoterol
Medicin: arformoterol tartrate inhalation solution
arformoterol 15 mcg BID
Andre navne:
  • Brovana
  • (R,R)-formoterol
Eksperimentel: 2
Arformoterol 25 mcg BID and Placebo MDI
Medicin: arformoterol tartrate inhalation solution
arformoterol 50 mcg QD
Andre navne:
  • (R,R)-formoterol
Medicin: arformoterol tartrate inhalation solution
arformoterol 25 mcg BID
Andre navne:
  • (R,R)-formoterol
Medicin: arformoterol tartrate inhalation solution
arformoterol 15 mcg BID
Andre navne:
  • Brovana
  • (R,R)-formoterol
Eksperimentel: 3
Arformoterol 15 mcg BID and placebo MDI
Medicin: arformoterol tartrate inhalation solution
arformoterol 50 mcg QD
Andre navne:
  • (R,R)-formoterol
Medicin: arformoterol tartrate inhalation solution
arformoterol 25 mcg BID
Andre navne:
  • (R,R)-formoterol
Medicin: arformoterol tartrate inhalation solution
arformoterol 15 mcg BID
Andre navne:
  • Brovana
  • (R,R)-formoterol
Aktiv komparator: 4
Salmeterol MDI 42 mcg BID and placebo inhalation solution
Medicin: Salmeterol
Salmeterol MDI 42 mcg BID
Andre navne:
  • Serevent MDI
Placebo komparator: 5
Placebo MDI and placebo inhalation solution
Medicin: Placebo
Placebo BID

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
percent change in trough FEV1 from study baseline to the end of the dosing interval (12 hours post-second dose for the BID treatment arms and 24 hours postdose for the QD treatment arm) over the double-blind period.
Tidsramme: Weeks -2, 0, 3, 6, 9, 12
Weeks -2, 0, 3, 6, 9, 12

Sekundære resultatmål

Resultatmål
Tidsramme
Topprocent af forudsagt FEV1
Tidsramme: Uge -2, 0, 3, 6, 9, 12
Uge -2, 0, 3, 6, 9, 12
time-normalized area under the percent change from visit predose curve for FEV1 over 12 hours (nAUC0-12-P)
Tidsramme: Weeks -2, 0, 3, 6, 9, 12
Weeks -2, 0, 3, 6, 9, 12
time-normalized area under the percent change in FEV1 from study baseline over 12 hours (nAUC0-12-B)
Tidsramme: Weeks -2, 0, 3, 6, 9, 12
Weeks -2, 0, 3, 6, 9, 12
time-normalized area under the percent change from visit predose curve for FEV1 over 24 hours (nAUC0-24-P)
Tidsramme: Weeks -2, 0, 3, 6, 9, 12
Weeks -2, 0, 3, 6, 9, 12
time-normalized area under the percent change in FEV1 from study baseline curve over 24 hours (nAUC0-24-B)
Tidsramme: Weeks -2, 0, 3, 6, 9, 12
Weeks -2, 0, 3, 6, 9, 12
peak percent change in FEV1 from visit predose and study baseline
Tidsramme: Weeks -2, 0, 3, 6, 9, 12
Weeks -2, 0, 3, 6, 9, 12
time point changes in FEV1; time to onset of response
Tidsramme: Weeks -2, 0, 3, 6, 9, 12
Weeks -2, 0, 3, 6, 9, 12
time to peak change in FEV1
Tidsramme: Weeks -2, 0, 3, 6, 9, 12
Weeks -2, 0, 3, 6, 9, 12
at-home and in-clinic peak expiratory flow rate (PEFR)
Tidsramme: Weeks -2, 0, 3, 6, 9, 12
Weeks -2, 0, 3, 6, 9, 12
relationship between the plasma concentration values and selected pharmacodynamic parameters
Tidsramme: Weeks -2, 0, 3, 6, 9, 12, 13
Weeks -2, 0, 3, 6, 9, 12, 13
Supplemental ipratropium bromide MDI and racemic albuterol MDI use
Tidsramme: Weeks 0-13
Weeks 0-13
COPD exacerbations and COPD symptom ratings
Tidsramme: Weeks 0-13
Weeks 0-13
St. George's Hospital Respiratory Questionnaire
Tidsramme: Weeks 0, 6, 13
Weeks 0, 6, 13
Investigator and Subject Global Evaluations
Tidsramme: Weeks -2, 12, 13
Weeks -2, 12, 13
Baseline and Transitional Dyspnea Index
Tidsramme: Weeks -2, 6, 12
Weeks -2, 6, 12
distance walked in six minutes
Tidsramme: Weeks -2, 3, 9
Weeks -2, 3, 9

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. april 2002

Primær færdiggørelse (Faktiske)

1. marts 2004

Studieafslutning (Faktiske)

1. marts 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

  • 091-051

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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