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

21. februar 2012 oppdatert av: 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

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

741

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

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:

  • 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

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: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 1
Arformoterol 50 mcg QD and placebo MDI
Legemiddel: arformoterol tartrate inhalation solution
arformoterol 50 mcg QD
Andre navn:
  • (R,R)-formoterol
Legemiddel: arformoterol tartrate inhalation solution
arformoterol 25 mcg BID
Andre navn:
  • (R,R)-formoterol
Legemiddel: arformoterol tartrate inhalation solution
arformoterol 15 mcg BID
Andre navn:
  • Brovana
  • (R,R)-formoterol
Eksperimentell: 2
Arformoterol 25 mcg BID and Placebo MDI
Legemiddel: arformoterol tartrate inhalation solution
arformoterol 50 mcg QD
Andre navn:
  • (R,R)-formoterol
Legemiddel: arformoterol tartrate inhalation solution
arformoterol 25 mcg BID
Andre navn:
  • (R,R)-formoterol
Legemiddel: arformoterol tartrate inhalation solution
arformoterol 15 mcg BID
Andre navn:
  • Brovana
  • (R,R)-formoterol
Eksperimentell: 3
Arformoterol 15 mcg BID and placebo MDI
Legemiddel: arformoterol tartrate inhalation solution
arformoterol 50 mcg QD
Andre navn:
  • (R,R)-formoterol
Legemiddel: arformoterol tartrate inhalation solution
arformoterol 25 mcg BID
Andre navn:
  • (R,R)-formoterol
Legemiddel: arformoterol tartrate inhalation solution
arformoterol 15 mcg BID
Andre navn:
  • Brovana
  • (R,R)-formoterol
Aktiv komparator: 4
Salmeterol MDI 42 mcg BID and placebo inhalation solution
Legemiddel: Salmeterol
Salmeterol MDI 42 mcg BID
Andre navn:
  • Serevent MDI
Placebo komparator: 5
Placebo MDI and placebo inhalation solution
Legemiddel: Placebo
Placebo BID

Hva måler studien?

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
Toppprosent av anslått FEV1
Tidsramme: Uker -2, 0, 3, 6, 9, 12
Uker -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

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. april 2002

Primær fullføring (Faktiske)

1. mars 2004

Studiet fullført (Faktiske)

1. mars 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

  • 091-051

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. .

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