- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00603629
Mechanisms of Acute Asthma Exacerbations Through Molecular Analysis of Airway Secretions and Tissues (MAST-X)
A Pilot Study Determining Mechanisms of Acute Asthma Exacerbations Through Detailed Molecular Analysis of Airway Secretions and Tissues
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Asthma is a common airway disease with persistent unmet needs in terms of treatment. Although many asthmatics enjoy good control of their disease by using regularly scheduled corticosteroid treatment, a significant minority do not achieve optimal control with steroids and suffer asthma exacerbations which can be severe and even fatal. Asthma pathophysiology is complex and involves multiple cell types and multiple signaling mechanisms. One approach to this complexity has been to study responses of isolated airway cells to experimental conditions which model asthmatic inflammation; another has been genetic manipulations of candidate mediators of asthma in inbred mice. These studies have yielded important insights about possible mechanisms of asthma in humans, but the relevance of these mechanisms to human disease has not always been proven, and it is possible that unsuspected mechanisms have not yet been revealed by these approaches.
In the current study, we propose to collect samples of airway secretions and blood from asthmatic subjects when their asthma is uncontrolled and they are being treated in the hospital or emergency room. Our goal will be to identify abnormal gene expression profiles and protein concentration abnormalities in these biological fluids. We will then study them again 6-10 weeks later when their asthma is controlled. This study design will allow us to compare airway and blood biomarkers of asthma exacerbation during acute asthma and recovery. "
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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California
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San Francisco, California, Forenede Stater, 94143
- UCSF Airway Clinical Research Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Male and female subjects aged 18 - 70 years
- Medical history of asthma
- Currently experiencing an acute exacerbation of asthma
- Ability to provide informed consent or have a surrogate provide consent.
- Ability to provide sputum.
Exclusion Criteria:
- Cigarette smoking: Subjects must be non-smokers. Non-smokers are defined as subjects who have never smoked or who have not smoked for 1 year and have a total pack-year smoking history < 10 packs.
- Pregnant women.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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I
People with acute asthma in the Emergency department or inpatient settings
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Hvad måler undersøgelsen?
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
gene expression in acute airway secretions and tissues
Tidsramme: 30 days
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30 days
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: John V Fahy, M.D., M.Sc., University of California, San Francisco
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H6788-31516-01
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