Ozone for Environmental and Genetic Factors on Lung Function

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Environmental and Genetic Factors on Lung FunctionOzone - Drug
Eligibility
18 - 45
All Sexes
What conditions do you have?
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Study Summary

This trial is testing how different environmental and genetic factors may affect lung function. It will screen participants over the course of one day, then have them come back for two days for more testing. This will include a blood draw and a breathing test before and after being exposed to either filtered air or ozone. Then, they will have a bronchoscopy to evaluate the lungs. They will repeat this process once more, 18-20 days later. There will be follow-up phone calls from the study team after each two-day test series. The whole study will last one to one-and-a-half months.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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SNDX-5613
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0.070 ppm ozone concentration

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Baseline, 21 days

Baseline, 21 days
Change in Ozone (O3) induced epithelial permeability, as measured by albumin level (ug/mL)
Change in Ozone (O3) induced epithelial permeability, as measured by the level of clara cell secretory protein (ng/mL)
Change in Ozone O3 induced alterations in bronchoalveolar lavage cytokines and growth factors
Change in Ozone O3 induced alterations in gene expression of airway epithelial cells, and bronchoalveolar lavage cells

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Nicotine Replacement
1
SNDX-5613
1
0.070 ppm ozone concentration

Trial Design

2 Treatment Groups

Ozone
1 of 2
Filtered Air
1 of 2

Experimental Treatment

Non-Treatment Group

100 Total Participants · 2 Treatment Groups

Primary Treatment: Ozone · Has Placebo Group · Phase < 1

Ozone
Drug
Experimental Group · 1 Intervention: Ozone · Intervention Types: Drug
Filtered Air
Other
PlaceboComparator Group · 1 Intervention: Filtered Air · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ozone
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 21 days

Who is running the clinical trial?

Robert Tighe, MDLead Sponsor
1 Previous Clinical Trials
70 Total Patients Enrolled

Eligibility Criteria

Age 18 - 45 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
is associated with increased response to CXCL10 The CXCR3 polymorphism rs2280964 is associated with a greater response to the chemokine CXCL10 in people with the wild-type gene expression, or in those who are homozygous for the CXCR3 variant (female) or hemizygous for the CXCR3 variant (male, since the gene is sex-linked).
of North Carolina People who live in the Raleigh-Durham area of North Carolina can enroll in a registry that tracks environmental polymorphisms.
References

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