Nitric Oxide, LPS and the Pathogenesis of Asthma Phase II
Stopped early · Phase 1
Conditions studied: Healthy
In brief
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 this study, we will determine the effect of inhaled endotoxin on exhaled NO in healthy African Americans, with and without NOS2 promoter polymorphisms. The protocol described in this submission will involve the use of NIH Clinical Center Reference Endotoxin which has been approved by the FDA under IND BB-IND-10035.
Key facts
- Study ID
- NCT00643058
- Run by
- John Sundy
- People needed
- 70
- Starts
- 2003-04-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2013-07-16
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.