Status:
TERMINATED
Nitric Oxide, LPS and the Pathogenesis of Asthma Phase II
Lead Sponsor:
John Sundy
Collaborating Sponsors:
Sandler Program for Asthma Research
Conditions:
Healthy
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to determine the role of nitric oxide (NO) in asthma and to characterize the symptoms associated with inhaled endotoxin (lipopolysaccharide \[LPS\]) in normal subjects. In ...
Detailed Description
(IRB# Pro00005035) The purpose of the study is to determine the role of nitric oxide (NO) in asthma and to characterize the symptoms associated with inhaled endotoxin in normal subjects. The effect o...
Eligibility Criteria
Inclusion
- Willing/able to give informed consent \& adhere to visit/protocol schedules
- non-atopic, non-asthmatic by PFT and allergy skin testing
- never cigarette smoker,
- no significant occupational exposure to respiratory irritants or toxins,
- no chronic illness
- no chronic use of medications (excluding contraceptive medication),
- no systemic corticosteroid use in the previous month,
- no historical or physical examination evidence of unstable cardiac or severe lung disease,
- Women of childbearing potential must have a negative serum pregnancy test
- baseline FEV1 \> 80% of the predicted value,
- no clinically significant abnormalities on the chest x-ray or EKG
Exclusion
- occupational exposure to hay or grain
- smoked 20 or more packs of cigarettes in a lifetime.
- prior allergen immunotherapy
- Allergy to potential study medications acetaminophen and albuterol
- Subjects who abuse alcohol or illicit substances will be excluded
- Viral respiratory infection within the previous 14 days
- Students or employees under direct supervision by protocol investigators are ineligible
- Nursing mothers
- Other investigational medication within the last 30 days
- Other medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00643058
Start Date
April 1 2003
End Date
December 1 2009
Last Update
July 16 2013
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710