NCT00643058

TerminatedPhase 1

Nitric Oxide, LPS and the Pathogenesis of Asthma Phase II

John Sundy Source

John Sundy

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

Pro00005035

Secondary identifiers

Pro00005035

12496-CP-006B

OTHER · NIEHS

Study Type

interventional

Actual enrollment (reported)

70

Locations

1 country

Sites

1

Timeline

Study Start

April 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2009

Actual (reported)

Study Completion

December 2009

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 70 participants
Study completion date: December 2009
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2003
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
March 24, 2008
Actual (reported)
First Posted
March 26, 2008
Actual (reported)
Primary Completion
July 2009
Actual (reported)
Study Completion
December 2009
Actual (reported)

Last Updated: July 16, 2013
Status Verified: July 2013
Last Update Submitted: July 15, 2013

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 endotoxinBiological

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 40 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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

Sponsors & Collaborators

Sandler Program for Asthma Research
Othercollaborator
John Sundy
Otherlead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

MeSH Terms

Interventions

trinitrophenyl-lipopolysaccharide

Study Officials

John C Sundy, M.D. PhD
Duke University
PRINCIPAL INVESTIGATOR

Enrollment

70 participants (actual enrollment reported by the registry).

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 2003

Date type not reported

This date has not been verified as actual or estimated.

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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

Contact the study team to confirm eligibility.

Primary Completion

July 2009

Actual (reported)

Study Completion

December 2009

Actual (reported)

Last Updated

July 16, 2013

Record last verified: 2013-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00643058
Data provider: ClinicalTrials.gov
Source updated: 2013-07-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:37 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations