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Observational and Epidemiologic Study of the Disease Course and Unmet Needs in Children With Symptomatic Moderate to Severe Allergic Asthma

15. juni 2011 oppdatert av: Novartis Pharmaceuticals

A 2-year Prospective, Multi-center, Observational and Epidemiologic Outcomes Study of the Disease Course and Unmet Needs in Children With Symptomatic Moderate to Severe Allergic Asthma

The study was designed to collect data about inadequately controlled moderate to severe allergic asthma in subjects 6 to < 12 years of age, managed in a real-world setting.

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

474

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35209
        • Novartis Investigative Site
    • California
      • Crescent City, California, Forente stater, 95531
        • Novartis Investigative Site
      • Fresno, California, Forente stater, 93726
        • Novartis Investigative Site
      • Oakland, California, Forente stater, 94609
        • Novartis Investigative Site
      • Orange, California, Forente stater, 92868
        • Novartis Investigative Site
      • Roseville, California, Forente stater, 95678
        • Novartis Investigative Site
      • Sacramento, California, Forente stater, 95819
        • Novartis Investigative Site
      • San Diego, California, Forente stater, 92120
        • Novartis Investigative Site
      • Walnut Creek, California, Forente stater, 94598
        • Novartis Investigative Site
    • Colorado
      • Thornton, Colorado, Forente stater, 80233
        • Novartis Investigative Site
    • Georgia
      • Albany, Georgia, Forente stater, 31707
        • Novartis Investigative Site
      • Atlanta, Georgia, Forente stater, 30342
        • Novartis Investigative Site
      • Columbus, Georgia, Forente stater, 31904
        • Novartis Investigative Site
      • Savannah, Georgia, Forente stater, 31406
        • Novartis Investigative Site
    • Indiana
      • Evansville, Indiana, Forente stater, 47713
        • Novartis Investigative Site
    • Kansas
      • Topeka, Kansas, Forente stater, 66606
        • Novartis Investigative Site
    • Kentucky
      • Cynthiana, Kentucky, Forente stater, 41031
        • Novartis Investigative Site
    • Louisiana
      • Metarie, Louisiana, Forente stater, 70002
        • Novartis Investigative Site
    • Massachusetts
      • Burlington, Massachusetts, Forente stater, 01801
        • Novartis Investigative Site
    • Michigan
      • Kalamazoo, Michigan, Forente stater, 49008
        • Novartis Investigative Site
      • Stevensville, Michigan, Forente stater, 49127
        • Novartis Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55402
        • Novartis Investigative Site
      • Plymouth, Minnesota, Forente stater, 55441
        • Novartis Investigative Site
    • Mississippi
      • Jackson, Mississippi, Forente stater, 39202
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63104
        • Novartis Investigative Site
    • Nebraska
      • Omaha, Nebraska, Forente stater, 16945
        • Novartis Investigative Site
    • New Jersey
      • Berkeley Heights, New Jersey, Forente stater, 07922
        • Novartis Investigative Site
      • Brick, New Jersey, Forente stater, 08724
        • Novartis Investigative Site
      • Summit, New Jersey, Forente stater, 07901
        • Novartis Investigative Site
      • West Orange, New Jersey, Forente stater, 07052
        • Novartis Investigative Site
    • New York
      • Batavia, New York, Forente stater, 14020
        • Novartis Investigative Site
      • Brooklyn, New York, Forente stater, 11229
        • Novartis Investigative Site
      • Rockville Center, New York, Forente stater, 11570
        • Novartis Investigative Site
    • North Carolina
      • High Point, North Carolina, Forente stater, 27262
        • Novartis Investigative Site
    • Ohio
      • Toledo, Ohio, Forente stater, 43604
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73112
        • Novartis Investigative Site
    • Oregon
      • Gresham, Oregon, Forente stater, 97030
        • Novartis Investigative Site
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater, 18104
        • Novartis Investigative Site
      • Altoona, Pennsylvania, Forente stater, 16601
        • Novartis Investigative Site
      • Pittsburgh, Pennsylvania, Forente stater, 15212
        • Novartis Investigative Site
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02906
        • Novartis Investigative Site
    • Tennessee
      • Kingsport, Tennessee, Forente stater, 37660
        • Novartis Investigative Site
    • Texas
      • Dallas, Texas, Forente stater, 75230
        • Novartis Investigative Site
      • Houston, Texas, Forente stater, 77054
        • Novartis Investigative Site
    • Utah
      • Murray, Utah, Forente stater, 84107
        • Novartis Investigative Site
    • Vermont
      • South Burlington, Vermont, Forente stater, 05403
        • Novartis Investigative Site
    • Virginia
      • Emporia, Virginia, Forente stater, 23847
        • Novartis Investigative Site
      • Norfolk, Virginia, Forente stater, 23507
        • Novartis Investigative Site
    • Washington
      • Bellingham, Washington, Forente stater, 98225
        • Novartis Investigative Site
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53715
        • Novartis Investigative Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • Novartis Investigative Site

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

6 år til 11 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Children aged 6 to less than 12 years old with moderate to severe allergic asthma for at least 12 months, treated with inhaled corticosteroids for at least 3 months but remaining symptomatic

Beskrivelse

Inclusion Criteria:

  • Total IgE ≥30 IU (historical values obtained within 3 months of screening visit will be accepted). If historic result not available, to be obtained at screening visit.
  • Diagnosis of asthma for at least 12 months prior to screening visit date, or symptoms compatible with asthma for at least 12 months if diagnosis made within 12 months of screening visit
  • Documented sensitivity to one or more perennial aeroallergens as evidenced by a positive skin prick test or in-vitro specific IgE test for dust mites, cat dander, dog dander or cockroach within the preceding one year of the screening visit
  • Prescribed inhaled corticosteroid for at least 3 months prior to screening (A) and having evidence of inadequately controlled disease either with at least one from list (B) OR history of asthma-related exacerbations as defined in (C). [e.g., A and (B or C)]

A. Fluticasone DPI > 200 mcg/day or equivalent ex-valve dose ICS, or if ≤ 200 mcg fluticasone DPI or equivalent plus another daily controller medication (i.e. LABA, leukotriene antagonist or theophylline)

B. At least one of the following in the preceding 4 weeks prior to the screening visit:

  • on average asthma symptoms > 2 days/week or multiple times in a day on ≤ 2 days/week
  • nighttime awakenings ≥ 2 times/month due to asthma symptoms
  • use of SABAs > 2 times/week on average
  • some limitation in activity due to asthma
  • on spirometric evaluation, FEV1 ≤ 80% of predicted, FEV1/FVC ≤ 80%, or peak expiratory flow rate ≤ 80% of personal best

C. Minimum of 2 asthma exacerbations requiring oral corticosteroid bursts in the 12 months previous to the screening visit

Exclusion Criteria:

  • Subjects currently enrolled in a clinical study of a therapeutic agent or biologic agent or who participated in a clinical study of a therapeutic agent within 30 days of Visit 1 or a biologic agent within 120 days of Visit 1
  • Subjects with a history of prior use of omalizumab
  • Subjects with a severe medical condition that in the view of the investigator prohibits participation in the study by either impairment in the ability to answer questions or follow instructions (e.g., severe neurological or developmental disorder)
  • Subjects with serious respiratory-related medical conditions other than allergic asthma such as, but not limited to, allergic bronchopulmonary aspergillosis, cystic fibrosis or bronchiectasis
  • Subjects with elevated serum IgE levels for reasons other than allergy such as, but not limited to, parasitic infections, hyperimmunoglobulin E syndrome, and Wiskott-Aldrich Syndrome

Other protocol-defined inclusion/exclusion criteria may apply

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Children 6 to less than 12 years of age

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
The change from basline in Childhood Asthma Control Test
Tidsramme: 2 years
2 years
The change from baseline in total Wasserfallen Clinical Symptom Score
Tidsramme: 2 years
2 years

Sekundære resultatmål

Resultatmål
Tidsramme
The change from baseline for overall score in the Standardized Pediatric Asthma Quality of Life Questionnaire (PAQLQ(S))
Tidsramme: 2 years
2 years
The change from baseline for overall score in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
Tidsramme: 2 years
2 years
The number of days of missed school.
Tidsramme: 2 years
2 years
The number of days of missed work.
Tidsramme: 2 years
2 years

Samarbeidspartnere og etterforskere

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

Sponsor

Novartis Pharmaceuticals

Samarbeidspartnere

Genentech, Inc.

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. februar 2008

Primær fullføring (Faktiske)

1. februar 2010

Datoer for studieregistrering

Først innsendt

26. mai 2011

Først innsendt som oppfylte QC-kriteriene

27. mai 2011

Først lagt ut (Anslag)

30. mai 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

16. juni 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juni 2011

Sist bekreftet

1. juni 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CIGE025BUS26

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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