- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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. "
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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California
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San Francisco, California, Förenta staterna, 94143
- UCSF Airway Clinical Research Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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I
People with acute asthma in the Emergency department or inpatient settings
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Vad mäter studien?
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
gene expression in acute airway secretions and tissues
Tidsram: 30 days
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30 days
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: John V Fahy, M.D., M.Sc., University of California, San Francisco
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H6788-31516-01
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