NCT00005550

Brief Summary

To evaluate airway inflammation in persons with asthma exposed to endotoxin, a common occupational air contaminant. Subjects are subsequently challenged with allergen.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

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

January 1, 1999

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

August 11, 2014

Status Verified

August 1, 2014

Enrollment Period

7.9 years

First QC Date

May 25, 2000

Last Update Submit

August 8, 2014

Conditions

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
No eligibility criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (7)

  • Alexis N, Eldridge M, Reed W, Bromberg P, Peden DB. CD14-dependent airway neutrophil response to inhaled LPS: role of atopy. J Allergy Clin Immunol. 2001 Jan;107(1):31-5. doi: 10.1067/mai.2001.111594.

    PMID: 11149987BACKGROUND
  • Eldridge MW, Peden DB. Airway response to concomitant exposure with endotoxin and allergen in atopic asthmatics. J Toxicol Environ Health A. 2000 Sep 15;61(1):27-37. doi: 10.1080/00984100050116762.

    PMID: 10990161BACKGROUND
  • Eldridge MW, Peden DB. Allergen provocation augments endotoxin-induced nasal inflammation in subjects with atopic asthma. J Allergy Clin Immunol. 2000 Mar;105(3):475-81. doi: 10.1067/mai.2000.104552.

    PMID: 10719296BACKGROUND
  • Alexis NE, Peden DB. Blunting airway eosinophilic inflammation results in a decreased airway neutrophil response to inhaled LPS in patients with atopic asthma: a role for CD14. J Allergy Clin Immunol. 2001 Oct;108(4):577-80. doi: 10.1067/mai.2001.118511.

    PMID: 11590384BACKGROUND
  • Alexis NE, Eldridge MW, Peden DB. Effect of inhaled endotoxin on airway and circulating inflammatory cell phagocytosis and CD11b expression in atopic asthmatic subjects. J Allergy Clin Immunol. 2003 Aug;112(2):353-61. doi: 10.1067/mai.2003.1651.

    PMID: 12897742BACKGROUND
  • Alexis NE, Becker S, Bromberg PA, Devlin R, Peden DB. Circulating CD11b expression correlates with the neutrophil response and airway mCD14 expression is enhanced following ozone exposure in humans. Clin Immunol. 2004 Apr;111(1):126-31. doi: 10.1016/j.clim.2003.12.002.

    PMID: 15093561BACKGROUND
  • Alexis NE, Lay JC, Almond M, Peden DB. Inhalation of low-dose endotoxin favors local T(H)2 response and primes airway phagocytes in vivo. J Allergy Clin Immunol. 2004 Dec;114(6):1325-31. doi: 10.1016/j.jaci.2004.09.002.

    PMID: 15577830BACKGROUND

MeSH Terms

Conditions

AsthmaLung DiseasesInflammation

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Peden

    University of North Carolina

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

January 1, 1999

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

August 11, 2014

Record last verified: 2014-08