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NCT01492517 · ClinicalTrials.gov registry record · NA

Epigenetic Effects of Diesel Exhaust and Ozone Exposure

A NA study, sponsored by Environmental Protection Agency (EPA).

Completed
Registry status
NA
Development phase
42
Enrollment target

NCT01492517: Completed NA study, sponsored by Environmental Protection Agency (EPA).

NCT01492517 is a NA study that has completed, run by Environmental Protection Agency (EPA). The registered enrollment target is 42 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01492517, a NA study, has completed, sponsored by Environmental Protection Agency (EPA).

COMPLETED
Registry status
NA
Development phase
42 participants
Enrollment target

Study Summary

Purpose: The purpose of this protocol is to compare the genetic and epigenetic effects between diesel exhaust and ozone exposure in healthy individuals and in mild/moderate asthmatics. Participants: The investigators will recruit up to 30 mild to moderate asthmatics and up to 50 healthy adults to participate in this study. Procedures (methods): Subjects will be exposed to clean air, to 300 µg/m3 of diesel exhaust for 2 hours and to 0.3 ppm of ozone for 2 hours with intermittent exercise in a controlled environment chamber. Primary endpoints will include spirometry and lung cell changes post-exposure. Secondary endpoints will include analysis of blood clotting/coagulation factors, Holter monitoring of cardiac parameters, analysis of soluble factors present in plasma and bronchial lavage and analysis of intracellular factors present in lung tissue obtained from a brush biopsy.

Primary Outcome

Airway responses include spirometry and lung cell changes following exposure to either clean air, ozone or diesel exhaust Lung cell changes include change in number and type of cells, changes in genetic (gene expression) and epigenetic responses (primarily changes in DNA methylation, microRNA expression and chromatin modification.

Interventions

  • OTHER Clean Air
  • OTHER Ozone exposure
  • OTHER Diesel exhaust
  • OTHER Ozone18

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2010-05
Est. Completion 2015-05
Phase NA

What the finished NCT01492517 record still lists

NCT01492517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 4 interventions - of which Clean Air is the first listed.

NCT01492517 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01492517 about?

NCT01492517 is a clinical study titled "Epigenetic Effects of Diesel Exhaust and Ozone Exposure". Purpose: The purpose of this protocol is to compare the genetic and epigenetic effects between diesel exhaust and ozone exposure in healthy individuals and in mild/moderate asthmatics. Participants: The investigators will recruit up to 30 mild to moderate asthmatics and up to 50 healthy adults to p...

What is the current status of trial NCT01492517?

This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2010-05. Estimated completion is 2015-05.

What interventions are being tested in trial NCT01492517?

The interventions under investigation include: Clean Air (OTHER), Ozone exposure (OTHER), Diesel exhaust (OTHER), Ozone18 (OTHER).

Who is sponsoring clinical trial NCT01492517?

This trial is sponsored by Environmental Protection Agency (EPA), which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01492517's enrollment target sits among peer trials

42 1436th of 2000 higher than 555 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT01492517, the US trial registry maintained by the National Library of Medicine. NCT01492517 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.