Nitric Oxide, LPS and the Pathogenesis of Asthma Phase II

NCT00643058 | Terminated Phase 1

• 2 other identifiers: Pro0000503512496-CP-006B
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

LPS endotoxin

Outcome Measures

Primary Outcomes (1)

• Differential response to inhaled LPS based on NOS2 inhibition.

  24 hours with optional 48 hr,72hr and 7 day follow up

Secondary Outcomes (1)

• Physiologic measurements

  24 hours with optional return up at 48 hrs, 72hrs and 7 day follow up

Study Arms (1)

1

EXPERIMENTAL

Sterile Saline, LPS endotoxin

Biological: LPS endotoxin

Interventions

LPS endotoxin BIOLOGICAL

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)

Also known as: Lipopolysaccaharide, Sterile Saline

1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• John Sundy: lead
• Sandler Program for Asthma Research: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

trinitrophenyl-lipopolysaccharide

Study Officials

• John C Sundy, M.D. PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 26, 2008
• Study Start: April 1, 2003
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 16, 2013

Record last verified: 2013-07

Locations

US (1)