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Nitric Oxide, LPS and the Pathogenesis of Asthma Phase II

This study has been terminated.
(Funding period completed.)
Sponsor:
Collaborator:
Sandler Program for Asthma Research
Information provided by (Responsible Party):
John Sundy, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00643058
First received: March 24, 2008
Last updated: July 15, 2013
Last verified: July 2013
  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 Phase
Healthy
Biological: LPS endotoxin
Phase 1

Study Type: Interventional
Study Design: 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 Duke University:

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 ]

Enrollment: 70
Study Start Date: April 2003
Study Completion Date: December 2009
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:
  • Lipopolysaccaharide
  • Sterile Saline

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: John Sundy, Associate Professor of Medicine, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00643058     History of Changes
Other Study ID Numbers: Pro00005035, Pro00005035, 12496-CP-006B
Study First Received: March 24, 2008
Last Updated: July 15, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Duke University:
LPS endotoxin

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

ClinicalTrials.gov processed this record on November 20, 2014