- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01334853
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
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
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Alberta
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Calgary, Alberta, Canada
- Research Site
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Edmonton, Alberta, Canada
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British Columbia
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Vancouver, British Columbia, Canada
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Ontario
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Toronto, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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Quebec City, Quebec, Canada
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Colorado
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Denver, Colorado, Forenede Stater
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Illinois
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Normal, Illinois, Forenede Stater
- Research Site
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Maryland
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Baltimore, Maryland, Forenede Stater
- Research Site
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Michigan
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Ann Arbor, Michigan, Forenede Stater
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Minnesota
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Rochester, Minnesota, Forenede Stater
- Research Site
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Missouri
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St. Louis, Missouri, Forenede Stater
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater
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Ohio
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Columbus, Ohio, Forenede Stater
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Pennsylvania
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Pittsburg, Pennsylvania, Forenede Stater
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Texas
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Galveston, Texas, Forenede Stater
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Houston, Texas, Forenede Stater
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Wisconsin
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Madison, Wisconsin, Forenede Stater
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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
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 |
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Cohort 1
50 eosinophilic subjects to be evaluated
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Biomarker
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Cohort 2
50 non-eosinophilic subjects to be evaluated
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Biomarker
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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To identify an optimal prediction rule for classifying sputum eosinophilic and non-eosinophilic asthmatics.
Tidsramme: 8 Days
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Variables representing lung function tests, patient reported outcomes, and blood biomarkers will be evaluated singly and in various combinations.
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8 Days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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To assess which markers are associated with sputum eosinophils.
Tidsramme: 8 Days
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Comparing lung function tests between eosinophilic and non-eosinophilic subjects.
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8 Days
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To assess which markers are associated with sputum eosinophils
Tidsramme: 8 Days
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Comparing blood biomarkers between eosinophilic and non-eosinophilic subjects
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8 Days
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To assess which markers are associated with sputum esonophils
Tidsramme: 8 Days
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Comparing sputum biomarkers bewteen eosinophilic and non-eosinophilic subjects
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8 Days
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To assess which markers are associated with sputum eosinophils.
Tidsramme: 8 Days
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Comparing patient reported outcomes between eosinophilic and non-eosinophilic subjects.
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8 Days
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To evaluate transcript expression profiles in whole blood and/or sputum using microarray analyses
Tidsramme: 8 Days
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8 Days
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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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MI-CP223
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 .