AzTrials
AzTrials

Lung Injury, AcutePhase 1LOCONOZ2NCT05680831

Pulmonary and Inflammatory Responses Following Exposure to a Low Concentration of Ozone or Clean Air

A Phase 1 study testing 0.070 ppm ozone concentration and Clean air (0.0 ppm ozone) in people with Lung Injury, Acute and Symptoms and Signs, run by Martin W. Case at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Purpose: The primary purpose of this study is to measure pulmonary function, symptoms, and pulmonary inflammatory responses in healthy young adults during and immediately after exposure to a low concentration of ozone (0.070 ppm) or clean air for 6.6 hours while undergoing moderate intermittent exercise. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
What is being tested?
0.070 ppm ozone concentration and Clean air (0.0 ppm ozone)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
13 Oct 2022to 1 Feb 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy men and women between 18 and 35 years of age.
  • Physical conditions allowing sustained moderate exercise for 6.6 hours.
  • Normal lung function (NHANES III):
  • FVC > 80 % of that predicted for gender, ethnicity, age and height.
  • FEV1 > 80 % of that predicted for gender, ethnicity, age and height.
  • FEV1/FVC ratio > 80 % of predicted values
  • Oxygen saturation > 94 %.
  • Total symptom Score no greater than 20 (out of a possible 60-see accompanying score sheet) with a value no greater than 3 for any one score. No more than one score may be equal to 3.

Who cannot join

  • Individuals with a diagnosis of COVID-19 and/or hospitalized for COVID-19.
  • Individuals who are not "up to date," [meaning a person has received all recommended COVID-19 vaccines, including any booster dose(s) when eligible with their COVID vaccines as defined by the CDC.]
  • A history of acute and chronic cardiovascular disease, chronic respiratory disease, diabetes,rheumatologic diseases, immunodeficiency state.
  • An acute respiratory illness within 4 weeks.
  • Subjects who are asthmatic or have a history of asthma.
  • Allergic to chemical vapors or gases.
Show all 25Show fewer
  • Any allergic symptoms during the time of participation in the study
  • Female subjects who are currently pregnant, attempting to become pregnant or breastfeeding
  • Subjects currently taking mega doses of vitamins and supplements, homeopathic/naturopathic medicines or medications which may impact the results of the ozone challenge or interfere with any other medications potentially used in the study (to include systemic steroids and beta blockers). Medications not specifically mentioned here may be reviewed by the investigators prior to a subject's inclusion in the study.
  • Current and past smokers within 2 years, or subjects with a smoking history of at least a pack of cigarettes a day for more than 10 years over your lifetime. This includes vaping, hookah,and e-cigarettes.
  • Uncontrolled hypertension (> 140 systolic, > 90 diastolic). Blood pressure readings equal to or greater that 140 Systolic and equal to or greater that 90 diastolic.
  • Subjects who do not understand or speak English
  • Unspecified illnesses, which in the judgment of the investigator might increase the risk associated with ozone inhalation challenge or exercise, will be a basis for exclusion.
  • Temporary exclusion criteria:
  • Individuals who have had an acute respiratory illness within 4 weeks.
  • Individuals who have active allergies.
  • Individuals that have engaged in strenuous exercise within 24 hours of any study visit.
  • Individuals unable to avoid drinking alcohol for 24 hours prior to all study visits.
  • Individuals who have been exposed to smoke and fumes for 24 hours before all visits.
  • Individuals that have used an ozone-based home air purifier for 24 hours before all visits.
  • Individuals that have eaten or drank anything for 2 hours prior to the sputum training/screening day visit.
  • Individuals should avoid caffeine for 12 hours prior to all study visits.
  • Individuals should refrain from all over the counter anti-inflammatory agents including those for allergies, and anti-inflammatory drugs or antioxidants for a period of one week prior to the train and to the exposure.
  • Individuals that have been exposed to or have consumed any agent or have undertaken any activity within 24 hours of any study visit that the investigators believe may compromise the results of the study.
  • -

Trial locations and contacts

1 site in 1 country.

Martin W Case, B.S. contact

919-966-6211

case.martin@epa.gov

Andrea Davis, R.N. contact

919-966-6241

davis.andrea@epa.gov

United States1 site, 1 recruiting

  • EPA Human Studies Facility

    Chapel Hill, North Carolina, 27599-7315

    Al Little, 919-966-5884, little.al@epa.gov

    Ana Rappold, Ph.D.

    Recruiting

Other trials in United States

About this study

Official title: Pulmonary and Inflammatory Responses Following Exposure to a Low Concentration of Ozone or Clean Air for 6.6 Hours With Moderate Exercise in Healthy Young Adults

Purpose: The primary purpose of this study is to measure pulmonary function, symptoms, and pulmonary inflammatory responses in healthy young adults during and immediately after exposure to a low concentration of ozone (0.070 ppm) or clean air for 6.6 hours while undergoing moderate intermittent exercise. This concentration is the current EPA NAAQS standard for ozone.

Read the detailed description

Potential health effects of ozone have been extensively studied over decades at various levels of exposure concentration and for varying time periods in young healthy adult subjects. Effects of ozone have been well documented particularly for decrements of lung function and an influx of neutrophils and other markers of pulmonary inflammation. The majority of those studies were done at ozone concentrations between 0.12 and 0.40 ppm, considerably higher than the current EPA NAAQS ozone standard of 0.070 ppm, and at exposure durations of two hours, even though the current standard is an 8-hour standard. However, a small number of studies have assessed changes in lung function following exposure to low levels of ozone for several hours. These latter studies have shown that exposure to ozone for 6.6 hours at concentrations between 0.06 and 0.08 ppm causes mild reversible decrements in lung function (1.7-10%) as measured by forced vital capacity (FVC) and forced expired volume at 1 s (FEV1) immediately after exposure in healthy young adults. In addition, in one study an increase in ozone-induced neutrophils was seen in induced sputum following exposure to 0.06 ppm ozone (8) and in bronchoalveolar lavage fluid) following exposure to 0.08 ppm ozone (9). The EPA is considering whether the current ozone NAAQS standard at 0.070 is protective and has asked EPA researchers to conduct a study similar to those done at 0.06 and 0.08 ppm.

Being tested
0.070 ppm ozone concentration, Clean air (0.0 ppm ozone)
Keywords
lungs, ozone concentration, exercise, inflammation, symptoms
Medical subject headings
Acute Lung Injury, Signs and Symptoms, Motor Activity, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.070 ppm ozone concentrationBiological

    The concentration of ozone a subject will randomly receive on a visit for 6.6 hours in a controlled atmospheric chamber while performing moderate intermittent exercise.

  • Clean air (0.0 ppm ozone)Biological

    Same subject will randomly receive clean air on another visit separated by at least one week for 6.6 hours in the same controlled atmospheric chamber while performing moderate intermittent exercise.

Study groups in NCT05680831
Study groupRoleWhat they receive
0.070 ppm ozone concentrationExperimentalExposure to 0.070 ppm ozone for 6.6 hours while performing moderate intermittent exercise.
Receives: Biological: 0.070 ppm ozone concentration
Clean air (0.0 ppm ozone)ExperimentalExposure to clean air (0.0 ppm ozone) for 6.6 hours while performing moderate intermittent exercise.
Receives: Biological: Clean air (0.0 ppm ozone)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FVC

    forced vital capacity

    Measured: measured (pre) before starting 6.6 hours of exercise

  2. Change in FVC

    change in forced vital capacity

    Measured: change measured (post) immediately after 6.6 hours of exercise

  3. FEV1

    forced expiratory volume in 1 second

    Measured: measured (pre) before starting 6.6 hours of exercise

  4. Change in FEV1

    change in forced expiratory volume in 1 second

    Measured: change measured (post) immediately after 6.6 hours of exercise

Secondary outcomes (2)

  1. % neutrophils collected by induced sputum

    Subjects will breathe a hypertonic saline solution from an ultrasonic nebulizer through a mouthpiece at saline concentrations of 3%, 4%, and 5%. After each inhalation period subjects be asked to cough up the expectorate in a sterile cup for analysis of neutrophil cells influx

    Measured: baseline: training/qualification day

  2. change in % neutrophils collected by induced sputum

    Subjects will breathe a hypertonic saline solution from an ultrasonic nebulizer through a mouthpiece at saline concentrations of 3%, 4%, and 5%. After each inhalation period subjects be asked to cough up the expectorate in a sterile cup for analysis/quantitation of neutrophil cells influx

    Measured: 18 hours post exposure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2023
  2. Study start13 Oct 2022
  3. Primary completion1 Feb 2024 (estimated)
  4. Study completion1 Feb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
This is a randomized, double-blind, cross-over study with two arms.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05680831
Sponsor's protocol ID
IRB# 21-3193
Acronym
LOCONOZ2
Status last verified
Jan 2023
First submitted
16 Dec 2022
Last updated
11 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 0.070 ppm ozone concentration and Clean air (0.0 ppm ozone) in people with Lung Injury, Acute and Symptoms and Signs, run by Martin W. Case at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Martin W Case, B.S. (919-966-6211, case.martin@epa.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FVC (time frame: measured (pre) before starting 6.6 hours of exercise). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05680831.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in