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Report for Clinical Trial NCT00643058

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Nitric Oxide, LPS and the Pathogenesis of Asthma - Phase II

The purpose of the study is to determine the role of nitric oxide (NO) in asthma and to characterize the symptoms associated with inhaled endotoxin (lipopolysaccharide [LPS]) in normal subjects. In this study, we will determine the effect of inhaled endotoxin on exhaled NO in healthy African Americans, with and without NOS2 promoter polymorphisms. The protocol described in this submission will involve the use of NIH Clinical Center Reference Endotoxin which has been approved by the FDA under IND BB-IND-10035.

NCT00643058 Healthy

1 Interventions

Name: LPS endotoxin

Description: Low challenge: saline (diluent), 5000EU, 10,000EU and 20,000EU LPS endotoxin as tolerated High challenge: Saline (diluent), 40,000EU and 80,000EU as tolerated Diluent Challenge: 3 X Sterile saline inhalation (2 ml)

Type: Biological

1


Primary Outcomes

Measure: Differential response to inhaled LPS based on NOS2 inhibition.

Time: 24 hours with optional 48 hr,72hr and 7 day follow up

Secondary Outcomes

Measure: Physiologic measurements

Time: 24 hours with optional return up at 48 hrs, 72hrs and 7 day follow up

Purpose: Basic Science

Single Group Assignment


There are 2 SNPs

SNPs


1 D299G

Because SNPs in the TLR4 gene result in a lack of airway obstruction in response to endotoxin, we will genotype the 1000 DNA samples for the Asp299Gly and Thr399Ile TLR4 polymorphisms in Phase 1 and exclude these individuals from the studies proposed in Phase 2. Likewise, CD14 serves as a coreceptor for endotoxin and polymorphisms in the CD14 gene and promoter have been associated with asthma and responsiveness to endotoxin. --- Asp299Gly ---


2 T399I

Because SNPs in the TLR4 gene result in a lack of airway obstruction in response to endotoxin, we will genotype the 1000 DNA samples for the Asp299Gly and Thr399Ile TLR4 polymorphisms in Phase 1 and exclude these individuals from the studies proposed in Phase 2. Likewise, CD14 serves as a coreceptor for endotoxin and polymorphisms in the CD14 gene and promoter have been associated with asthma and responsiveness to endotoxin. --- Asp299Gly --- --- Thr399Ile ---



HPO Nodes