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Nitric Oxide, LPS and the Pathogenesis of Asthma Phase II

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ClinicalTrials.gov Identifier: NCT00643058
Recruitment Status : Terminated (Funding period completed.)
First Posted : March 26, 2008
Last Update Posted : July 16, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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 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 or disease Intervention/treatment Phase
Healthy Biological: LPS endotoxin Phase 1

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Nitric Oxide, LPS and the Pathogenesis of Asthma - Phase II
Study Start Date : April 2003
Primary Completion Date : July 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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:
  • Lipopolysaccaharide
  • Sterile Saline


Outcome Measures

Primary Outcome Measures :
  1. Differential response to inhaled LPS based on NOS2 inhibition. [ Time Frame: 24 hours with optional 48 hr,72hr and 7 day follow up ]

Secondary Outcome Measures :
  1. Physiologic measurements [ Time Frame: 24 hours with optional return up at 48 hrs, 72hrs and 7 day follow up ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643058


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
John Sundy
Sandler Program for Asthma Research
Investigators
Principal Investigator: John C Sundy, M.D. PhD Duke University
More Information

Responsible Party: John Sundy, Associate Professor of Medicine, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00643058     History of Changes
Other Study ID Numbers: Pro00005035
12496-CP-006B ( Other Identifier: NIEHS )
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: July 16, 2013
Last Verified: July 2013

Keywords provided by John Sundy, Duke University Medical Center:
LPS endotoxin

Additional relevant MeSH terms:
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents