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Proposal 928

Title of the Proposed Research

Lung function and airway inflammation response after ozone exposure 0.25ppm

Lead Researcher

Krista Todoric, MD

Affiliation

UNC Hospitals
Chapel Hill, NC
USA

Funding Source

None required - study included has already been completed

Potential Conflicts of Interest

None

Data Sharing Agreement Date

24 July 2014

Lay Summary

Well-recognized effects of ozone exposure include reduction in lung function and airway inflammation. However, the timing and degree of such effects as impacted by study design have not been well-characterized.

At this time, we are interested better characterizing pulmonary inflammation directly associated with 0.25ppm ozone exposure in order to compare this response to other doses of ozone used in prior studies which we have also previously completed. Our group previously helped to complete a dose-finding study for fluticasone using 0.25ppm ozone exposure in association with GSK (Study CR291039, “A dose ranging study to assess the effect of pre-treatment with a single dose of oral prednisolone (50 mg, 10 mg) or inhaled fluticasone propionate (2 mg, 0.5 mg) on lung inflammation following challenge with inhaled ozone and intermittent exercise in healthy volunteers, relative to placebo”). Although we do have individual sputum evaluation for individuals within the GSK study, we do not have access to individual lung function (FEV1, FVC) or cytokine profiles (Il-1, IL-6, IL-8, IL-10).

The main purpose of comparing 0.25ppm ozone exposure to other doses of ozone (0.4ppm and 0.08ppm) is to better define ozone-induced effects. This should inform future study using ozone. Our preliminary works suggests that higher dose ozone has greater impact on lung function immediately following ozone exposure but that airway neutrophilia may be identical depending on lenght of time of exposure at a lower dose. As these types of studies may also be completed in at-risk populations (e.g. asthmatics), it is important to understand how study design impacts airway inflammation and nocioceptive response to ozone exposure.

We will be comparing all three studies (including data from the 0.25ppm exposure) with basic statistical methods (t-test or nonparametric equivalent as well as correlation) to better determine whether there is significant difference between the three groups with respect to change in FEV1, neutrophilia, or cytokine profiles.

We plan to report the comparison of these findings in a peer-reviewed journal. Although we may comment on original study design and basic characteristics of the study groups (ethnicity, asthmatic, age, gender, etc), no individual data will be reported.

Study Data Provided

Study CR219039: A dose ranging study to assess the effect of pre-treatment with a single dose of inhaled fluticasone propionate (2 mg, 0.5 mg) on lung inflammation following challenge with inhaled ozone and intermittent exercise in healthy volunteers, relative to placebo

Statistical Analysis Plan

This will be added after the research is published.

Publication Citation