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Nitric Oxide, LPS and the Pathogenesis of Asthma Phase II

NCT00643058 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2013-07-16

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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)

Sponsors & Collaborators

  • Sandler Program for Asthma Research

    collaborator OTHER

  • John Sundy

    lead OTHER

Principal Investigators

  • John C Sundy, M.D. PhD · Duke University

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2009-07-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00643058 on ClinicalTrials.gov