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NCT03599206 · ClinicalTrials.gov registry record · Early Phase 1

ONES Grant: CXCL10/CXCR3 Regulation of Ozone-Induced Epithelial Permeability

A Early Phase 1 study of Environmental and Genetic Factors on Lung Function, sponsored by Robert Tighe, MD.

Completed
Registry status
Early Phase 1
Development phase
14
Enrollment target
1
Study location

NCT03599206: Completed Early Phase 1 study of Environmental and Genetic Factors on Lung Function, sponsored by Robert Tighe, MD.

NCT03599206 is a Early Phase 1 study of Environmental and Genetic Factors on Lung Function that has completed, run by Robert Tighe, MD. The registered enrollment target is 14 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03599206, a Early Phase 1 study of Environmental and Genetic Factors on Lung Function, has completed, sponsored by Robert Tighe, MD.

COMPLETED
Registry status
Early Phase 1
Development phase
14 participants
Enrollment target
1
Study location

Study Summary

The purpose of this research study to understand how environmental and genetic factors may be involved in lung function. Study participants will undergo a 1-day screening that includes a blood draw and breathing testing, return for a two-day series of testing to include blood draw, and brief breathing test before and after an inhaled challenge with either filtered air (FA) or ozone (O3). Participants return the next day for a brief breathing test, a blood draw and a procedure called bronchoscopy to evaluate the lung after the challenge. Participants then return 18 - 20 days later to repeat the two-day series of testing to be challenged with the exposure not received on the first series, (FA or O3). Each visit will take about 3 - 3.5 hours. Follow-up phone calls from the study team will occur at 24 hours after each 2-day test series. Total study duration is about one to one-and a half months.

Primary Outcome

This measure is defined by the comparing each individuals baseline (following filtered air challenge) to the ozone response. The investigators will perform two tests on this response as a means of confirmation. The individual will have blood drawn to obtain serum and a bronchoscopy to obtain bronchoalveolar lavage. The serum will be used to determine the level of clara cell secretory protein. This is measured by enzyme-linked immunosorbent assay (ELISA). The value is reported as ng/mL.

Interventions

  • DRUG Ozone
  • OTHER Filtered Air

Study Locations (1)

North Carolina

  • Duke Asthma, Allergy, and Airway Center - Durham

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2019-08-16
Est. Completion 2024-01-24
Phase Early Phase 1
Robert Tighe, MD

3 total trials

What the finished NCT03599206 record still lists

NCT03599206 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (74% lower).

The record links to 1 condition, with Environmental and Genetic Factors on Lung Function appearing as the primary indexed condition, and to 2 interventions - of which Ozone is the first listed.

NCT03599206 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT03599206 about?

NCT03599206 is a clinical study titled "ONES Grant: CXCL10/CXCR3 Regulation of Ozone-Induced Epithelial Permeability". The purpose of this research study to understand how environmental and genetic factors may be involved in lung function. Study participants will undergo a 1-day screening that includes a blood draw and breathing testing, return for a two-day series of testing to include blood draw, and brief breathi...

What is the current status of trial NCT03599206?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 14 participants. The study started on 2019-08-16. Estimated completion is 2024-01-24.

What conditions does trial NCT03599206 study?

This clinical trial studies the following conditions: Environmental and Genetic Factors on Lung Function.

What interventions are being tested in trial NCT03599206?

The interventions under investigation include: Ozone (DRUG), Filtered Air (OTHER).

Who is sponsoring clinical trial NCT03599206?

This trial is sponsored by Robert Tighe, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03599206 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT03599206's enrollment target sits among peer trials

14 1475th of 2000 higher than 498 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03599206, the US trial registry maintained by the National Library of Medicine. NCT03599206 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.