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Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma

12. oktober 2011 oppdatert av: Novartis Pharmaceuticals

A 26-week Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma

This study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in the 2007 National Heart, Lung, and Blood Institute (NHBLI) Guidelines

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

271

Fase

  • Fase 4

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
        • Jasper Summit Research, LLC
    • Alaska
      • Anchorage, Alaska, Forente stater, 99508
        • Allergy Asthma and Immunology Center of Alaska
    • Arizona
      • Scottsdale, Arizona, Forente stater, 85251
        • Medical Research of Arizona, A division of Allergy Asthma & Immunology Associates, LTD
    • California
      • Encinitas, California, Forente stater, 92024
        • Waren W. Pleskow, MD
      • Fresno, California, Forente stater, 93720
        • William Ebbeling, MD, Inc
      • Huntington Beach, California, Forente stater, 92647
        • Pediatric Care Medical Group, Inc
      • Palmdale, California, Forente stater, 93551
        • California Allergy & Asthma Medical Group
      • San Diego, California, Forente stater, 92120
        • Allergy Associates Medical Group, Inc
      • Santa Barbara, California, Forente stater, 93110
        • Sansum Clinic
      • Walnut Creek, California, Forente stater, 94598
        • Allergy & Asthma Clinical Research, Inc.
    • Florida
      • Clearwater, Florida, Forente stater, 33756
        • Innovative Research of West Florida, Inc
      • Hialeah, Florida, Forente stater, 33012
        • Palm Spring Research Institute, Inc
      • Pensacola, Florida, Forente stater, 32514
        • Integrity Research, LLC
      • Sarasota, Florida, Forente stater, 34233
        • Hugh Windom, MD, PA
      • South Miami, Florida, Forente stater, 33143
        • South Miami Clinical Research, LLC
    • Georgia
      • Albany, Georgia, Forente stater, 31707
        • Georgia Pollens Clinical Research Centers, Inc
    • Illinois
      • Normal, Illinois, Forente stater, 61761
        • Sneeze, Wheeze and Itch Associates, LLC
      • Skokie, Illinois, Forente stater, 60076
        • Chest Medicine Clinical Services
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46208
        • Clinical Research Center of Indiana
    • Kansas
      • Overland Park, Kansas, Forente stater, 66210
        • Kansas City Allergy & Asthma Center
      • Topeka, Kansas, Forente stater, 66606
        • Cotton-O'Neil Clinical Research Center
    • Kentucky
      • Crescent Springs, Kentucky, Forente stater, 41017
        • Abraham Research, PLLC
    • Louisiana
      • Metairie, Louisiana, Forente stater, 70002
        • Rx R&D
      • Opelousas, Louisiana, Forente stater, 70570
        • Acadiana Medicine Clinic
    • Maine
      • Bangor, Maine, Forente stater, 04401
        • Paul A Shapero, MD
    • Maryland
      • Baltimore, Maryland, Forente stater, 21236
        • Chesapeake Clinical Research
    • Michigan
      • Ypsilanti, Michigan, Forente stater, 48197
        • Respiratory Medicine Research Institute of Michigan
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55402
        • Clinical Research Institute
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63141
        • The Clinical Research Center, LLC
    • Montana
      • Missoula, Montana, Forente stater, 59808
        • Montana Medical Research, Inc.
    • New York
      • Bronx, New York, Forente stater, 10465
        • Alan Kaufman, MD
      • Brooklyn, New York, Forente stater, 11219
        • Maimonides Medical Center, Division of Pediatric Pulmonology
      • Rochester, New York, Forente stater, 14618
        • Allergy Asthma Immunology of Rochester Research Center
    • North Carolina
      • High Point, North Carolina, Forente stater, 27262
        • Allergy & Asthma Center of NC, PA
      • Wilmington, North Carolina, Forente stater, 28401
        • Wilmington Medical Research
    • Ohio
      • Canton, Ohio, Forente stater, 44718
        • Allergy and Respiratory Center
      • Cincinnati, Ohio, Forente stater, 45242
        • New Horizons Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73120
        • Allergy, Asthma and Clinical Research Center
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • Oklahoma Allergy & Asthma Clinic
    • Oregon
      • Lake Oswego, Oregon, Forente stater, 97035
        • Baker Allergy Asthma and Dermatology Research Center, LLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Asthma Allergy & Pulmonary Associates
    • Rhode Island
      • Lincoln, Rhode Island, Forente stater, 02865
        • AAPRI Clinical Research Institute
    • Texas
      • Dallas, Texas, Forente stater, 75230
        • Pediatric Pulmonary Associates of North Texas, PA
      • El Paso, Texas, Forente stater, 79903
        • Western Sky Medical Research
      • Fort Worth, Texas, Forente stater, 76132
        • North Texas Institute for Clinical Trials
      • Houston, Texas, Forente stater, 77054
        • Allergy & Asthma Associates
    • Virginia
      • Lynchburg, Virginia, Forente stater, 24501
        • Lynchburg Pulmonary Associates
      • Richmond, Virginia, Forente stater, 23229
        • Virginia Adult and Pediatric Allergy and Asthma PC
    • Washington
      • Seattle, Washington, Forente stater, 98105
        • Asthma Inc.
      • Spokane, Washington, Forente stater, 99204
        • Pulmonary and Research 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

12 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Total Asthma Control Test (ACT) score of ≤19 plus at least one of the following in the 4 weeks preceding visit 1, on average:

    • Symptoms > 2 days/week
    • Night-time awakenings ≥1 time/week
    • Short-acting beta2-agonist (SABA) use for symptom control >2 days/week forced expiratory volume in 1 second (FEV1) ≤ 80% predicted

Exclusion Criteria:

  • History of intubation for asthma.
  • An asthma exacerbation requiring treatment with systemic steroids within 4 weeks of screening (Visit 1).
  • Less than 3 months of stable maintenance oral corticosteroid therapy for asthma

Other protocol-defined inclusion/exclusion criteria applied

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: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Omalizumab
The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
Legemiddel: Omalizumab
Omalizumab was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of omalizumab for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.
Andre navn:
  • Xolair
Placebo komparator: Placebo
Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
Legemiddel: Placebo
Placebo was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of placebo for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment
Tidsramme: Baseline and 24 weeks
The Asthma Control Test (ACT) is a validated tool to assess overall asthma control over the last 4 weeks in patients aged >= 12 years old. It is a 1 page questionnaire consisting of 5 simple questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores are added together to calculate a total score. Total score ranges from 5 to 25. A positive change indicates improvement.
Baseline and 24 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks
Tidsramme: 24 weeks
The IGETE is an assessment of asthma symptom control in response to asthma treatment. It consists of the question "What is the investigator's overall impression of the study medication and its effect on the typical symptoms of allergic asthma during the study?" The scale is: excellent, good, moderate, poor, and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment.
24 weeks

Samarbeidspartnere og etterforskere

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

Sponsor

Novartis Pharmaceuticals

Samarbeidspartnere

Genentech, Inc.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

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. mars 2009

Primær fullføring (Faktiske)

1. mars 2010

Studiet fullført (Faktiske)

1. mars 2010

Datoer for studieregistrering

Først innsendt

25. mars 2009

Først innsendt som oppfylte QC-kriteriene

25. mars 2009

Først lagt ut (Anslag)

27. mars 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

17. november 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. oktober 2011

Sist bekreftet

1. oktober 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CIGE025AUS33

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