Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma
12. oktober 2011 opdateret af: 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
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
271
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Jasper, Alabama, Forenede Stater, 35501
- Jasper Summit Research, LLC
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Alaska
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Anchorage, Alaska, Forenede Stater, 99508
- Allergy Asthma and Immunology Center of Alaska
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85251
- Medical Research of Arizona, A division of Allergy Asthma & Immunology Associates, LTD
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California
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Encinitas, California, Forenede Stater, 92024
- Waren W. Pleskow, MD
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Fresno, California, Forenede Stater, 93720
- William Ebbeling, MD, Inc
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Huntington Beach, California, Forenede Stater, 92647
- Pediatric Care Medical Group, Inc
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Palmdale, California, Forenede Stater, 93551
- California Allergy & Asthma Medical Group
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San Diego, California, Forenede Stater, 92120
- Allergy Associates Medical Group, Inc
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Santa Barbara, California, Forenede Stater, 93110
- Sansum Clinic
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Walnut Creek, California, Forenede Stater, 94598
- Allergy & Asthma Clinical Research, Inc.
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Florida
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Clearwater, Florida, Forenede Stater, 33756
- Innovative Research of West Florida, Inc
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Hialeah, Florida, Forenede Stater, 33012
- Palm Spring Research Institute, Inc
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Pensacola, Florida, Forenede Stater, 32514
- Integrity Research, LLC
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Sarasota, Florida, Forenede Stater, 34233
- Hugh Windom, MD, PA
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South Miami, Florida, Forenede Stater, 33143
- South Miami Clinical Research, LLC
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Georgia
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Albany, Georgia, Forenede Stater, 31707
- Georgia Pollens Clinical Research Centers, Inc
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Illinois
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Normal, Illinois, Forenede Stater, 61761
- Sneeze, Wheeze and Itch Associates, LLC
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Skokie, Illinois, Forenede Stater, 60076
- Chest Medicine Clinical Services
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46208
- Clinical Research Center of Indiana
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Kansas
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Overland Park, Kansas, Forenede Stater, 66210
- Kansas City Allergy & Asthma Center
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Topeka, Kansas, Forenede Stater, 66606
- Cotton-O'Neil Clinical Research Center
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Kentucky
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Crescent Springs, Kentucky, Forenede Stater, 41017
- Abraham Research, PLLC
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Louisiana
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Metairie, Louisiana, Forenede Stater, 70002
- Rx R&D
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Opelousas, Louisiana, Forenede Stater, 70570
- Acadiana Medicine Clinic
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Maine
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Bangor, Maine, Forenede Stater, 04401
- Paul A Shapero, MD
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Maryland
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Baltimore, Maryland, Forenede Stater, 21236
- Chesapeake Clinical Research
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Michigan
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Ypsilanti, Michigan, Forenede Stater, 48197
- Respiratory Medicine Research Institute of Michigan
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55402
- Clinical Research Institute
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Missouri
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Saint Louis, Missouri, Forenede Stater, 63141
- The Clinical Research Center, LLC
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Montana
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Missoula, Montana, Forenede Stater, 59808
- Montana Medical Research, Inc.
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New York
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Bronx, New York, Forenede Stater, 10465
- Alan Kaufman, MD
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Brooklyn, New York, Forenede Stater, 11219
- Maimonides Medical Center, Division of Pediatric Pulmonology
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Rochester, New York, Forenede Stater, 14618
- Allergy Asthma Immunology of Rochester Research Center
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North Carolina
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High Point, North Carolina, Forenede Stater, 27262
- Allergy & Asthma Center of NC, PA
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Wilmington, North Carolina, Forenede Stater, 28401
- Wilmington Medical Research
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Ohio
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Canton, Ohio, Forenede Stater, 44718
- Allergy and Respiratory Center
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Cincinnati, Ohio, Forenede Stater, 45242
- New Horizons Clinical Research
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73120
- Allergy, Asthma and Clinical Research Center
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Oklahoma Allergy & Asthma Clinic
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Oregon
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Lake Oswego, Oregon, Forenede Stater, 97035
- Baker Allergy Asthma and Dermatology Research Center, LLC
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Asthma Allergy & Pulmonary Associates
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Rhode Island
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Lincoln, Rhode Island, Forenede Stater, 02865
- AAPRI Clinical Research Institute
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Texas
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Dallas, Texas, Forenede Stater, 75230
- Pediatric Pulmonary Associates of North Texas, PA
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El Paso, Texas, Forenede Stater, 79903
- Western Sky Medical Research
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Fort Worth, Texas, Forenede Stater, 76132
- North Texas Institute for Clinical Trials
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Houston, Texas, Forenede Stater, 77054
- Allergy & Asthma Associates
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Virginia
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Lynchburg, Virginia, Forenede Stater, 24501
- Lynchburg Pulmonary Associates
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Richmond, Virginia, Forenede Stater, 23229
- Virginia Adult and Pediatric Allergy and Asthma PC
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Washington
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Seattle, Washington, Forenede Stater, 98105
- Asthma Inc.
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Spokane, Washington, Forenede Stater, 99204
- Pulmonary and Research Associates
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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
12 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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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 navne:
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Placebo komparator: Placebo
Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment
Tidsramme: Baseline and 24 weeks
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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.
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Baseline and 24 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks
Tidsramme: 24 weeks
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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.
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24 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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. marts 2009
Primær færdiggørelse (Faktiske)
1. marts 2010
Studieafslutning (Faktiske)
1. marts 2010
Datoer for studieregistrering
Først indsendt
25. marts 2009
Først indsendt, der opfyldte QC-kriterier
25. marts 2009
Først opslået (Skøn)
27. marts 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. november 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. oktober 2011
Sidst verificeret
1. oktober 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CIGE025AUS33
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 .