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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 March 2013 |
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Main ID: |
NCT01073410 |
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Date of registration:
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19/02/2010 |
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Primary sponsor: |
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Public title:
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Chitinases and Transforming Growth Factor Beta (TGFB) in Human Asthma
AADCRC |
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Scientific title:
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Chitinases and TGFB in Human Asthma |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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45 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01073410 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Kelly Norsworthy, BA |
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Address:
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Telephone:
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415-502-8791 |
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Email:
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kelly.norsworthy@ucsf.edu |
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Affiliation:
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Name:
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Kelly Norsworthy, BA |
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Address:
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Telephone:
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415-502-8791 |
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Email:
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kelly.norsworthy@ucsf.edu |
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Affiliation:
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Name:
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John V Fahy, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Francisco |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- History of asthma
- No use of oral or inhaled corticosteroids for the treatment of asthma in the past 6
weeks
- Hyperreactivity to methacholine (PC20FEV1 Methacholine = 8.0 mg/mL).
- At least one of the following symptoms, beta agonist use, or FEV1 criteria:
- Asthma symptoms on at least two days per week, or
- Beta agonist use on at least two days per week, or
- FEV1 < 85% predicted
- Subjects must be non-smokers (patients who have never smoked or patients who have not
smoked for 1 year and have a total pack-year smoking history < 15 packs).
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 < 15 packs.
- Pregnant women
- Subjects with a history of a medical disease which in the opinion of the investigator
may put the subject at extra risk from study-related procedures or because the
disease may influence the results of the study.
- Healthy control subjects must have no history of asthma or allergic rhinitis
- Upper respiratory tract infection in the 4 weeks prior to enrollment in the study
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Asthma
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Primary Outcome(s)
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Expression of CHIT1, AMCase, and TGFb pathway genes in asthma
[Time Frame: Current]
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Secondary ID(s)
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H6788-32208
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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