Nitric Oxide, LPS and the Pathogenesis of Asthma Phase II

This study is currently recruiting participants.

Verified by National Institute of Environmental Health Sciences (NIEHS), May 2008

First Received: March 24, 2008 Last Updated: May 2, 2008 History of Changes

Sponsors and Collaborators:	National Institute of Environmental Health Sciences (NIEHS) Sandler Program for Asthma Research
Information provided by:	National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:	NCT00643058

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

MedlinePlus related topics: Asthma

Drug Information available for: Nitric oxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Nitric Oxide, LPS and the Pathogenesis of Asthma - Phase II

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
1: Experimental 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)

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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

National Institute of Environmental Health Sciences (NIEHS)

Sandler Program for Asthma Research

Investigators

Principal Investigator:

Marc C Levesque, M.D. PhD

Duke University

More Information

No publications provided

Responsible Party:	Duke University Medical Center ( Marc Levesque M.D. PhD. )
Study ID Numbers:	12496-CP-006B, Pro00005035
Study First Received:	March 24, 2008
Last Updated:	May 2, 2008
ClinicalTrials.gov Identifier:	NCT00643058 History of Changes
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

Study placed in the following topic categories:

Nitric Oxide
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Anti-Asthmatic Agents

Asthma
Cardiovascular Agents
Peripheral Nervous System Agents
Healthy
Bronchodilator Agents

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cardiovascular Agents
Protective Agents

Pharmacologic Actions
Nitric Oxide
Autonomic Agents
Therapeutic Uses
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on May 07, 2009