Role of TLR4 in Environmental Asthma

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ClinicalTrials.gov Identifier: NCT00671892

Recruitment Status : Completed

First Posted : May 5, 2008

Last Update Posted : July 16, 2013

Sponsor:

Information provided by (Responsible Party):

John Sundy, Duke University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Asthma	Biological: Lipopolysaccharide endotoxin	Phase 1

Show Detailed Description

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	855 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Basic Science
Official Title:	Role of TLR4 in Environmental Asthma
Study Start Date :	September 2001
Actual Primary Completion Date :	August 2006
Actual Study Completion Date :	April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Arm

Intervention/treatment

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

Outcome Measures

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 ]

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


Responsible Party:	John Sundy, Associate Professor of Medicine, Duke University
ClinicalTrials.gov Identifier:	NCT00671892 History of Changes
Other Study ID Numbers:	3030-07-8R5 12496-CP-007 ( Other Identifier: NIEHS )
First Posted:	May 5, 2008 Key Record Dates
Last Update Posted:	July 16, 2013
Last Verified:	July 2013

Keywords provided by John Sundy, Duke University:


LPS endotoxin asthma

Additional relevant MeSH terms:


Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases	Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases

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