Role of TLR4 in Environmental Asthma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00671892 |
Recruitment Status :
Completed
First Posted : May 5, 2008
Last Update Posted : July 16, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Biological: Lipopolysaccharide endotoxin | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 855 participants |
Allocation: | N/A |
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 |
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 |
- 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 ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | John S Sundy, M.D., PhD. | Duke University |
Responsible Party: | John Sundy, Associate Professor of Medicine, Duke University |
ClinicalTrials.gov Identifier: | NCT00671892 |
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 |
LPS endotoxin asthma |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |