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Ozone Exposure for Acute Lung Injury (LOCONOZ2 Trial)

Phase 1
Recruiting
Led By Andy Ghio, M.D.
Research Sponsored by Martin W. Case
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Total symptom Score no greater than 20 with a value no greater than 3 for any one score. No more than one score may be equal to 3
Normal lung function (NHANES III): FVC > 80% of predicted, FEV1 > 80% of predicted, FEV1/FVC ratio > 80% of predicted values, Oxygen saturation > 94%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured (pre) before starting 6.6 hours of exercise
Awards & highlights

LOCONOZ2 Trial Summary

This trial studies the effects of ozone exposure on breathing and lung inflammation in healthy young adults while exercising.

Who is the study for?
Healthy adults aged 18-35 with normal lung function and the ability to do moderate exercise for 6.6 hours can join this trial. Pregnant women, smokers, those with asthma or recent respiratory illness, uncontrolled hypertension, or not up-to-date on COVID vaccines are excluded.Check my eligibility
What is being tested?
The study is testing how breathing in a low concentration of ozone (0.070 ppm) compared to clean air affects lung function and inflammation during/after exercising for 6.6 hours in healthy young adults.See study design
What are the potential side effects?
Potential side effects may include coughing, shortness of breath, chest tightness, throat irritation or other symptoms related to lung inflammation due to ozone exposure.

LOCONOZ2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My symptoms are mild, with none too severe.
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My lung function is within normal range.
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I am between 18 and 35 years old and healthy.

LOCONOZ2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured (pre) before starting 6.6 hours of exercise
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured (pre) before starting 6.6 hours of exercise for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in FEV1
Change in FVC
FEV1
+1 more
Secondary outcome measures
% neutrophils collected by induced sputum
change in % neutrophils collected by induced sputum

LOCONOZ2 Trial Design

2Treatment groups
Experimental Treatment
Group I: Clean air (0.0 ppm ozone)Experimental Treatment1 Intervention
Exposure to clean air (0.0 ppm ozone) for 6.6 hours while performing moderate intermittent exercise.
Group II: 0.070 ppm ozone concentrationExperimental Treatment1 Intervention
Exposure to 0.070 ppm ozone for 6.6 hours while performing moderate intermittent exercise.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of North CarolinaOTHER
167 Previous Clinical Trials
1,449,567 Total Patients Enrolled
Martin W. CaseLead Sponsor
Andy Ghio, M.D.Principal InvestigatorEPA/ORD/CPHEA/PHITD/CRB

Media Library

Exposure to 0.070 ppm Ozone Concentration (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05680831 — Phase 1
Symptoms Research Study Groups: Clean air (0.0 ppm ozone), 0.070 ppm ozone concentration
Symptoms Clinical Trial 2023: Exposure to 0.070 ppm Ozone Concentration Highlights & Side Effects. Trial Name: NCT05680831 — Phase 1
Exposure to 0.070 ppm Ozone Concentration (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05680831 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any spots available for those wishing to partake in this experiment?

"Clinicaltrials.gov has documented that this research study, first shared on October 13th 2022, is actively accepting participants for participation. The trial was most recently modified on January 9th 2023."

Answered by AI

Is this research study open to adults of all ages?

"The age restriction to take part in this experiment is 18-35 and those outside of this range have other trials they can participate in; there are 23 studies for minors, while 125 clinical trials involve seniors."

Answered by AI

Does the FDA approve of a 0.070 ppm ozone concentration level?

"At Power, we rate the safety of 0.070 ppm ozone concentration as a 1 due to its Phase 1 status, meaning there is limited data suggesting effectiveness and security."

Answered by AI

What is the total enrollment capacity of this trial?

"Affirmative. The clinicaltrials.gov record of the medical trial suggests that it is presently recruiting participants. Initially posted on October 13th 2022, the study has since been updated as recently as January 9th 2023 and requires 60 individuals to be accepted between one centre."

Answered by AI

To what demographic is enrollment of this trial open?

"This medical trial is searching for 60 participants with acute lung injury who are aged between 18 and 35. Eligibility requires healthy men or women in the aforementioned age bracket to possess a FVC greater than 80%, an FEV1 higher than 80% of predicted values, oxygen saturation above 94%, and a Total Symptom Score no more than 20 (with none exceeding 3)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pulmonary and Inflammatory Responses Following Exposure to a Low Concentration of Ozone or Clean Air
Martin W. Case 2022. "Pulmonary and Inflammatory Responses Following Exposure to a Low Concentration of Ozone or Clean Air". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05680831.
~24 spots leftby Apr 2025
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