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NCT01981135 · ClinicalTrials.gov registry record · NA
Interaction Effects of Temperature and Ozone
A NA study, sponsored by Environmental Protection Agency (EPA).
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
NCT01981135: Completed NA study, sponsored by Environmental Protection Agency (EPA).
NCT01981135 is a NA study that has completed, run by Environmental Protection Agency (EPA). The registered enrollment target is 16 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01981135, a NA study, has completed, sponsored by Environmental Protection Agency (EPA).
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
Study Summary
Purpose: The purpose of this protocol is to understand how individuals respond to the air pollutant ozone at elevated temperatures. Ultimately, this will help us understand what the risks from poor air quality are during a heat wave. Participants: We will recruit up to 30 healthy adults, 18-55 years old, to participate in this study. Procedures (methods): Subjects will be exposed to clean air and to 0.3 ppm of ozone for 2 hours with intermittent exercise in a controlled environment chamber. For each exposure the temperature in the chamber will be between 31-34oC (88-93 oF). Because the aim of the study is to mimic high exposure during a heat wave, we will perform exposures only on days when mean ambient temperatures was less than 24 oC in Chapel Hill on the previous day. Primary endpoints will include spirometry and Heart Rate Variability monitoring. Secondary endpoints will include analysis of blood clotting/coagulation factors, and analysis of soluble factors present in plasma.
Primary Outcome
Forced expired volume in the first second (FEV1) is determined by spirometry performed on a dry seal spirometer interfaced to a computer.
Interventions
- OTHER Clean Air
- OTHER Ozone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2011-09 |
| Est. Completion | 2015-01 |
| Phase | NA |
What the finished NCT01981135 record still lists
NCT01981135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Clean Air is the first listed.
NCT01981135 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01981135 about?
NCT01981135 is a clinical study titled "Interaction Effects of Temperature and Ozone". Purpose: The purpose of this protocol is to understand how individuals respond to the air pollutant ozone at elevated temperatures. Ultimately, this will help us understand what the risks from poor air quality are during a heat wave. Participants: We will recruit up to 30 healthy adults, 18-55 year...
What is the current status of trial NCT01981135?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2011-09. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01981135?
The interventions under investigation include: Clean Air (OTHER), Ozone (OTHER).
Who is sponsoring clinical trial NCT01981135?
This trial is sponsored by Environmental Protection Agency (EPA), which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01981135's enrollment target sits among peer trials
16 1871st of 2000 higher than 120 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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