Status:
WITHDRAWN
Asthma Exacerbation Study
Lead Sponsor:
University of Pittsburgh
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Asthma is a clinical syndrome that is well recognized by health care practitioners, yet asthma pathogenesis still remains poorly understood. Asthma affects approximately 20 million Americans, who suff...
Eligibility Criteria
Inclusion
- All adults (age 18 and older) with moderate-severe persistent asthma identified by their physicians at the Comprehensive Lung Center and UPMC network physicians, and those individuals self-referred to the asthma research center will be considered for enrollment.
- All subjects will be involved in the research design first by participating in clinical testing to characterize the absence of any respiratory disease and the severity of asthma.
- Clinical testing will include:
- spirometry
- methacholine challenge (when necessary for diagnosis)
- allergy testing
- nitric oxide monitoring.
- These tests will be performed as part of the research design on all adult subjects ages 18-60.
- Only patients on inhaled corticosteroids (CS) regularly at doses of \>200 micrograms/day (fluticasone or equivalent) will be entered into the trial. There is no upper limit of CS dose.
Exclusion
- The presence of any of the following will exclude a patient from study enrollment:
- Subjects with mental handicaps
- Subjects with obvious lower respiratory tract bacterial infection (pneumonia)
- Subjects who are unable to provide consent directly and for whom an appropriate legal representative cannot be found to provide consent
- Subjects who have previously indicated that they do not wish to be enrolled in this study.
- A greater than five pack year history of smoking or current smoking.
- A prior diagnosis of vocal cord dysfunction, cystic fibrosis or chronic obstructive pulmonary disorder as well as any other lung disease besides asthma, or any coronary artery disease, hypertension, diabetes or renal failure that is not well-controlled as deemed by the principal investigator.
- Use of the 5 lipoxygenase inhibitor zileuton
- Regular use of aspirin or other nonsteroidal anti-inflammatory (intermittent use will be allowed, but patients will be asked to take acetaminophen while in the exacerbation phase of the trial if anti-pyretic/analgesic medication is required.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00853411
Start Date
December 1 2008
End Date
February 1 2011
Last Update
March 22 2016
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