← Back to Search

Ozone (O3) for Ozone Exposure Syndrome

N/A

Recruiting

Led By Michael Koehle, MD, PhD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately prior to exercise, 10, 20, and 30-minutes into the submaximal constant work-rate cycling bout, immediately and 30-minutes following maximal cycling bout.

Awards & highlights

Study Summary

This trialwill examine the effects of ground level ozone on the respiratory system and exercise performance. It aims to discover which people are most affected.

Eligible Conditions

Ozone Exposure Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately prior to exercise, 10, 20, and 30-minutes into the submaximal constant work-rate cycling bout, immediately and 30-minutes following maximal cycling bout.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately prior to exercise, 10, 20, and 30-minutes into the submaximal constant work-rate cycling bout, immediately and 30-minutes following maximal cycling bout.

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately prior to exercise, 10, 20, and 30-minutes into the submaximal constant work-rate cycling bout, immediately and 30-minutes following maximal cycling bout. 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 FEF25-75 post-exercise

Change in FEV1 post-exercise

Change in FVC post-exercise

+7 more

Secondary outcome measures

Change in blood lactate values

Dyspnea

Change in fraction of exhaled nitric oxide (FeNO)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ozone (O3)Experimental Treatment2 Interventions

Participants of the experimental group will perform sub-maximal exercise (power output associated with 10% below anaerobic threshold for 30 minutes) and maximal exercise (time-to-exhaustion test at 5% above previously determined maximal power output) on a cycle ergometer while inhaling 170ppb ozone delivered continuously during each exercise session.

Group II: Room airPlacebo Group2 Interventions

Participants of the sham group will perform sub-maximal exercise (power output associated with 10% below anaerobic threshold for 30 minutes) and maximal exercise (time-to-exhaustion test at 5% above previously determined maximal power output) on a cycle ergometer while inhaling room air during each exercise session.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise

2016

Completed Phase 1

~760

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,413 Previous Clinical Trials

2,466,946 Total Patients Enrolled

Natural Sciences and Engineering Research Council, CanadaOTHER

57 Previous Clinical Trials

3,074 Total Patients Enrolled

Michael Koehle, MD, PhDPrincipal InvestigatorUniversity of British Columbia

3 Previous Clinical Trials

68 Total Patients Enrolled

Frequently Asked Questions

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

Who has the opportunity to participate in this experiment?

"This trial is seeking 15 volunteers aged 18 to 50 who have been exposed to ozone during rest and exercise. Further eligibility criteria include: male gender, good English communicative abilities, current involvement in endurance sports, and a VO2max of more than 60 ml/kg/min."

Answered by AI

Is this experiment recruiting geriatric individuals?

"This trial mandates the minimum age for enrollment be 18, and capping the upper limit at 50."

Answered by AI

How many participants are being accepted into this clinical investigation?

"Affirmative. Clinicaltrials.gov data implies that this clinical trial, which was first posted on August 18th 2022, is actively enrolling participants. About 15 patients need to be recruited from 1 medical centre."

Answered by AI

Are there any opportunities for individuals to take part in this research?

"Affirmative, the details on clinicaltrials.gov display that this medical trial is actively seeking volunteers. The study was first posted on August 18th 2022 and has undergone recent modifications as of December 12th 2022. Currently, 15 participants need to be sourced from one site."

Answered by AI

What aims are investigators seeking to accomplish with this trial?

"This medical trial's primary aim is to observe the shift in ventilatory patterns during a 10, 20, and 30-minute submaximal constant work-rate cycling bout. Secondary outcomes include fluctuations of exhaled nitric oxide (FeNO) as a noninvasive marker for airway inflammation, changes in symptoms reported via an investigator-developed questionnaire which runs from 0 (no feelings of the symptom) to 5 (the worst ever experienced), and readings of blood lactate values indicating exercise intensity and energy system contribution."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Susceptibility of Cardiorespiratory Responses to Ozone During Cycling Exercise

Michael Koehle 2022. "Susceptibility of Cardiorespiratory Responses to Ozone During Cycling Exercise". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05473000.