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A Study to Assess Selected Biomarkers in Subjects Requiring Daily Inhaled Corticosteroids for Persistent Asthma

10. oktober 2012 opdateret af: MedImmune LLC

A Prospective Observational Study to Assess the Role of Selected Biomarkers in Subjects Requiring Daily Medium- to High-dose Inhaled Corticosteroids for Persistent Asthma

The rationale for conducting this study is to explore potential clinical and peripheral biomarkers in subjects requiring daily medium to high dose inhaled corticosteroids for persistent asthma

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

97

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Edmonton, Alberta, Canada
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
    • Ontario
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
      • Quebec City, Quebec, Canada
        • Research Site
    • Colorado
      • Denver, Colorado, Forenede Stater
        • Research Site
    • Illinois
      • Normal, Illinois, Forenede Stater
        • Research Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater
        • Research Site
    • Minnesota
      • Rochester, Minnesota, Forenede Stater
        • Research Site
    • Missouri
      • St. Louis, Missouri, Forenede Stater
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater
        • Research Site
    • Ohio
      • Columbus, Ohio, Forenede Stater
        • Research Site
    • Pennsylvania
      • Pittsburg, Pennsylvania, Forenede Stater
        • Research Site
    • Texas
      • Galveston, Texas, Forenede Stater
        • Research Site
      • Houston, Texas, Forenede Stater
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater
        • Research Site

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

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adults with asthma on stable medium- to high-dose inhaled corticosteroids.

Beskrivelse

Inclusion Criteria:

  • Age 18 through 75 at the time of screening
  • Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
  • History of physician-diagnosed asthma for at least 12 months prior to screening
  • Stable Medium- to high-dose ICS divided twice daily as outlined by the NHLBI Asthma Guidelines, 2007

Exclusion Criteria:

  • Any medical condition that, in the opinion of the investigator or medical monitor, would interfere with interpretation of subject safety or study results
  • Concurrent enrollment in another clinical study
  • Use of immunosuppressive medication within 3 months prior to screening
  • Acute upper or lower respiratory infections requiring antibiotics or antiviral medications with in 30 days prior to screening or during screning period.
  • Receipt of immunoglobulin or blood products within 30 days prior to screening or during the screening period
  • Receipt of any investigational non-biological drug therapy within 30 days or 5 half-lives prior to screening whichever is longer; or receipt of any marketed or investigational biologic within 6 months or 5 half-lives prior to screening whichever is longer
  • Pregnant, lactating, or breastfeeding woman
  • Diagnosis of lung disease other than persistent asthma
  • History of smoking ≥10 pack years or any smoking within 12 months prior to screening
  • History of active, infectious hepatitis A, B, C or human immunodeficiency virus (HIV)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Cohort 1
50 eosinophilic subjects to be evaluated
Biomarker
Cohort 2
50 non-eosinophilic subjects to be evaluated
Biomarker

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To identify an optimal prediction rule for classifying sputum eosinophilic and non-eosinophilic asthmatics.
Tidsramme: 8 Days
Variables representing lung function tests, patient reported outcomes, and blood biomarkers will be evaluated singly and in various combinations.
8 Days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To assess which markers are associated with sputum eosinophils.
Tidsramme: 8 Days
Comparing lung function tests between eosinophilic and non-eosinophilic subjects.
8 Days
To assess which markers are associated with sputum eosinophils
Tidsramme: 8 Days
Comparing blood biomarkers between eosinophilic and non-eosinophilic subjects
8 Days
To assess which markers are associated with sputum esonophils
Tidsramme: 8 Days
Comparing sputum biomarkers bewteen eosinophilic and non-eosinophilic subjects
8 Days
To assess which markers are associated with sputum eosinophils.
Tidsramme: 8 Days
Comparing patient reported outcomes between eosinophilic and non-eosinophilic subjects.
8 Days
To evaluate transcript expression profiles in whole blood and/or sputum using microarray analyses
Tidsramme: 8 Days
8 Days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Studieleder: David Gossage, M.D., MedImmune LLC

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. januar 2011

Primær færdiggørelse (Faktiske)

1. april 2012

Studieafslutning (Faktiske)

1. september 2012

Datoer for studieregistrering

Først indsendt

28. marts 2011

Først indsendt, der opfyldte QC-kriterier

12. april 2011

Først opslået (Skøn)

13. april 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. oktober 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. oktober 2012

Sidst verificeret

1. oktober 2012

Mere information

Begreber relateret til denne undersøgelse

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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