Nitric Oxide, LPS and the Pathogenesis of Asthma Phase II
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by National Institute of Environmental Health Sciences (NIEHS).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Collaborator:
Sandler Program for Asthma Research
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:
NCT00643058
First received: March 24, 2008
Last updated: May 2, 2008
Last verified: May 2008
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Healthy |
Biological: LPS endotoxin |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Nitric Oxide, LPS and the Pathogenesis of Asthma - Phase II |
Resource links provided by NLM:
Further study details as provided by National Institute of Environmental Health Sciences (NIEHS):
Primary Outcome Measures:
- Differential response to inhaled LPS based on NOS2 inhibition. [ Time Frame: 24 hours with optional 48 hr,72hr and 7 day follow up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Physiologic measurements [ Time Frame: 24 hours with optional return up at 48 hrs, 72hrs and 7 day follow up ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Sterile Saline, LPS endotoxin
|
Biological: LPS endotoxin
Low challenge: saline (diluent), 5000EU, 10,000EU and 20,000EU LPS endotoxin as tolerated High challenge: Saline (diluent), 40,000EU and 80,000EU as tolerated Diluent Challenge: 3 X Sterile saline inhalation (2 ml) Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00643058
Contacts
| Contact: Catherine M Foss, BSed RRT | (919) 668-3599 | foss0005@mc.duke.edu |
Locations
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Marc C Levesque, MD, PhD 919-613-7931 marc.levesque@duke.edu | |
| Contact: John S Sundy, MD, PhD (919) 668-2169 john.sundy@duke.edu | |
| Principal Investigator: Marc C Levesque, MD, PhD | |
Sponsors and Collaborators
Sandler Program for Asthma Research
Investigators
| Principal Investigator: | Marc C Levesque, M.D. PhD | Duke University |
More Information
No publications provided
| Responsible Party: | Marc Levesque M.D. PhD., Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00643058 History of Changes |
| Other Study ID Numbers: | 12496-CP-006B, Pro00005035 |
| Study First Received: | March 24, 2008 |
| Last Updated: | May 2, 2008 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
|
LPS endotoxin |
Additional relevant MeSH terms:
|
Anti-Asthmatic Agents Nitric Oxide Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Respiratory System Agents Therapeutic Uses |
Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Vasodilator Agents Cardiovascular Agents Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013