NCT00924768

Brief Summary

The purpose of this Phase 1 research study is to identify a dose of inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other problems), but causes changes in sputum cell samples that the scientists can measure. The investigators are also interested in seeing if the exposure to the endotoxin decreases the body's natural ability to clear mucus from the lungs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started May 2009

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 6, 2013

Status Verified

August 1, 2013

Enrollment Period

3.1 years

First QC Date

June 17, 2009

Last Update Submit

August 3, 2013

Conditions

HealthyCigarette Smoking

Keywords

Otherwise healthy current cigarette smokerscurrent cigarette smokers

Outcome Measures

Primary Outcomes (1)

  • Increase in sputum neutrophils

    6 hours

Secondary Outcomes (1)

  • Mucociliary clearance rates

    4 hours

Study Arms (1)

Endotoxin

EXPERIMENTAL

Inhalation of 20K EU CCRE

Biological: 20K EU CCRE

Interventions

20K EU CCREBIOLOGICAL

Inhalation of CCRE

Endotoxin

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Must be current cigarette smokers
  • Must be otherwise healthy
  • Must be good sputum producers

You may not qualify if:

  • Any acute illness any chronic illness which would impact results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Study Officials

  • David Peden

    University of NC Chapel Hill Hospitals

    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
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

June 17, 2009

First Posted

June 19, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 6, 2013

Record last verified: 2013-08

Locations

US(1)