Role of TLR4 in Environmental Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Sundy, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00671892
First received: May 2, 2008
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

The overall goal of this project is to identify genes that are involved in the development of airflow obstruction and airway inflammation in asthmatics, and to determine whether polymorphisms in these differentially expressed genes predispose individuals to develop asthma. In this project, we hypothesize that polymorphisms of genes expressed by the airway epithelia in asthmatics following specific airway challenges predispose individuals to the development of asthma.


Condition Intervention Phase
Asthma
Biological: Lipopolysaccharide endotoxin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Role of TLR4 in Environmental Asthma

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Ascertain individuals homozygous, and heterozygous for mutant TLR4 genotype, along with wild types by recruitment of healthy screening subjects in the community. [ Time Frame: completed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the effect of TLR4 genotype on LPS endotoxin induced immune responses and assess the association of the LPS-induced immune response with LPS-induced airway responses. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 855
Study Start Date: September 2001
Study Completion Date: April 2008
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Challenge

Experimental Challenge Challenge 1 saline 5000EU 10,000EU 20,000EU

Challenge 2 Saline 40,000EU 80,000EU

Biological: Lipopolysaccharide endotoxin

Delivered in nebulized form expressed in activity units(endotoxin units -EU).

Subjects receive each dose 30 min after completing the previous dose, dose duration is approximately 10 minutes:

Challenge One first saline then 5000 EU 10,000 EU 20,000 EU

Challenge 1 and 2 must be at least 2 weeks apart.

Challenge 2 Saline 40,000 EU 80,000 EU

Other Name: (CCRE)LPS endotoxin from E. Coli 0:113 maintained by NIH

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • vital signs within normal limits
  • negative methacholine challenge (non asthmatic)
  • normal PFT's, CXR, EKG
  • negative allergy skin tests (non atopic)
  • never cigarette smoker
  • no chronic illness
  • no daily meds except contraceptives
  • able and willing to sign informed consent
  • not an employee working for,or a student under the authority of the PI's

Exclusion Criteria:

  • allergic rhinitis past or present
  • chronic illness resulting in altered lung function
  • chronic daily medications
  • cigarette smoking
  • allergy to acetaminophen or albuterol
  • pregnant or nursing females
  • PFT results below cut off
  • Positive allergy skin test
  • Abnormal CXR or EKG
  • Positive methacholine challenge
  • Infection in the previous 2 weeks
  • Past or present allergen immunotherapy
  • Occupational exposure to hay or grain
  • Other medical or psychological conditions which, in the opinion of the PI, may create undue risk to the subject or interfere with the subject's ability to comply with protocol requirements.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671892

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
John Sundy
Investigators
Principal Investigator: John S Sundy, M.D., PhD. Duke University
  More Information

No publications provided

Responsible Party: John Sundy, Associate Professor of Medicine, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00671892     History of Changes
Other Study ID Numbers: 3030-07-8R5, 12496-CP-007
Study First Received: May 2, 2008
Last Updated: July 15, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Duke University:
LPS endotoxin
asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 20, 2014