Environmental ExposureSNOZNCT02857283
Human Biological Responses to Low Level Ozone
A study testing Ozone, Filtered Air and Health and Exposure Tracker (HET) in people with Environmental Exposure and Nasal Inflammation, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
To investigate if low level ozone exposure will cause measurable inflammation in nasal cells. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Environmental Exposure, Nasal Inflammation
- What is being tested?
- Ozone, Filtered Air and Health and Exposure Tracker (HET)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2017to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females between 18 and 50 years of age.
- Vital signs within normal limits on admission to the study: Peripheral oxygen saturation (SpO2) > 94%, systolic blood pressure between 150-90 mm Hg, diastolic blood pressure between 100-60 mm Hg, afebrile.
- Forced Expiratory Volume (FEV1) of at least 80% of predicted.
Who cannot join
- Any chronic medical condition considered by the PI as a contraindication to the exposure study, including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, chronic thyroid disease, or kidney disease.
- Use of systemic or inhaled steroids.
- Use of NSAID or aspirin within 7days of each study visit, and inability to withhold these medications prior to each session of the study.
- Pregnant or nursing women
- Use of cigarettes or other inhaled nicotine products within the past year, or more than a lifetime 5 pack year history of cigarette smoking.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, 27599
About this study
To investigate if low level ozone exposure will cause measurable inflammation in nasal cells.
Read the detailed description
Air pollutants including ozone have been implicated in affecting health outcomes. In particular, high level ozone exposure has been shown to affect pulmonary function and cause pulmonary inflammation. Troubling community-based work has implicated high ozone levels as being correlated with increased pediatric asthma emergency room visits. Because of adverse health effects, EPA standards for safe ozone levels have been set, currently at 0.07 ppm. Still, it is estimated that 100 million Americans live in areas where ozone levels periodically remain above the EPA standard. And while this EPA standard had been set based on available data, it remained unclear at the time whether naturalistic low-level ozone exposure, such as fluctuations between 0.06-0.08 ppm throughout the day, might affect health as well.
This group previously examined lung function and inflammatory response in adults exposed to low-level ozone, 0.06 ppm exposure for 6.6 hours, while undergoing intermittent moderate exercise. The investigators found that in response to low-level ozone exposure (0.06 ppm) with exercise, lung function declines and neutrophilic airway inflammation is observed. What remains unclear, is whether low-level ozone alone - without exercise - will cause similar health effects.
To mimic exposure to ozone on a typical summer day in a polluted city, the investigators will expose subjects to a varying level of ozone, form 0.06 ppm to 0.08 ppm, rather than a constant 0.07ppm. The variation from 0.06ppm to 0.08ppm, then back to 0.06ppm will occur each hour.
- Conditions
- Environmental Exposure, Nasal Inflammation
- Being tested
- Ozone, Filtered Air, Health and Exposure Tracker (HET)
- Keywords
- Air pollution, Air pollutant exposure, Ozone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzoneOther
Participants will be exposed to a concentration of ozone for 6.5 hours at a concentration that varies 0.06 to 0.08
Filtered AirOther
Participants will be exposed to filtered clean air
Health and Exposure Tracker (HET)Device
Ozone and heart rate tracker
| Study group | Role | What they receive |
|---|---|---|
| Filtered Air, then Ozone | Experimental | Participants in this arm will first receive filtered clean air followed by ozone Receives: Other: Ozone; Other: Filtered Air; Device: Health and Exposure Tracker (HET) |
| Ozone, then Filtered Air | Experimental | Participants in this arm will first receive ozone followed by filtered clean air Receives: Other: Ozone; Other: Filtered Air; Device: Health and Exposure Tracker (HET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in % Polymorphonuclear Leukocytes (PMN) in Nasal Lavage Fluid Immediately Post-Exposure From Baseline
Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Nasal lavage fluid (NLF) will be collected from participants at a baseline visit within two weeks prior to each exposure, and at the following time points for each exposure: immediately after exiting the exposure chamber, and at 24 hours after the exposure.
The % PMN as a percentage of total inflammatory cells (total of monocytes and macrophages, PMN, eosinophils, basophils, lymphocytes, and bronchial epithelial cells) will be determined in each NLF collection by differential counts of cells on cytospin slides. The change in the values from baseline to immediately Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3.
Measured: Baseline, immediately post-exposure
Change in % Polymorphonuclear Leukocytes (PMN) in Nasal Lavage Fluid 24 Hours Post-Exposure From Baseline
Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Nasal lavage fluid (NLF) will be collected from participants at a baseline visit within two weeks prior to each exposure, and at the following time points for each exposure: immediately after exiting the exposure chamber, and at 24 hours after the exposure.
The % PMN as a percentage of total inflammatory cells (total of monocytes and macrophages, PMN, eosinophils, basophils, lymphocytes, and bronchial epithelial cells) will be determined in each NLF collection by differential counts of cells on cytospin slides. The change in the values from baseline to 24 hours Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3.
Measured: Baseline, 24 hours post-exposure
Secondary outcomes (13)
Interleukin-6 (IL-6) Concentrations in Nasal Epithelial Lining Fluid (ELF): Change Immediately Post-Exposure From Baseline
Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Nasal epithelial lining (ELF) will be collected from participants at a baseline visit within two weeks prior to each exposure, and at the following time points for each exposure: immediately after exiting the exposure chamber, and at 24 hours after the exposure.
The IL-6 concentration will be determined in each ELF sample by immunoassay. The change in IL-6 concentrations from baseline to immediately Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3 to determine the effect of ozone on the production of nasal IL-6.
Measured: Baseline, immediately post-exposure
% Polymorphonuclear Leukocytes (PMN) in Induced Sputum: Change 24 Hours Post-Exposure From Screening Visit
Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Induced sputum will be collected from participants after inhaled hypertonic saline. Induced sputum will be collected at the screening visit within six weeks prior to the first exposure, and at 24 hours after each exposure.
The % PMN as a percentage of total inflammatory cells (total of monocytes and macrophages, PMN, eosinophils, basophils, lymphocytes, and bronchial epithelial cells) will be determined in each induced sputum collection by differential counts of cells on cytospin slides. The change in the values from baseline to 24 hours Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3.
Measured: Screening visit and 24 hours post-exposure
The Percentage of Predicted Forced Expiratory Volume in One Second (% Predicted FEV1): Change Immediately Post-Exposure From Baseline
Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Standard spirometry to obtain FEV1 and forced vital capacity (FVC) measurements will be done at baseline within two weeks prior to first exposure, and immediately after exiting the exposure chamber for each exposure.
The % Predicted FEV1 will be calculated from measured versus expected values. The change in % Predicted FEV1 from baseline to immediately Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3 to determine the effect of ozone on the % Predicted FEV1.
Measured: Baseline, immediately post-exposure
Interleukin-6 (IL-6) Concentrations in Nasal Epithelial Lining Fluid (ELF): Change 24 Hours Post-Exposure From Baseline
Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Nasal epithelial lining (ELF) will be collected from participants at baseline within two weeks prior to first exposure, and at the following time points for each exposure: immediately after exiting the exposure chamber, and at 24 hours after the exposure.
The IL-6 concentration will be determined in each ELF sample by immunoassay. The change in IL-6 concentrations from baseline to 24 hours Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3 to determine the effect of ozone on the production of nasal IL-6.
Measured: Baseline, 24 hours post-exposure
Interleukin-8 (IL-8) Concentrations in Nasal Epithelial Lining Fluid (ELF): Change Immediately Post-Exposure From Baseline
Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Nasal epithelial lining (ELF) will be collected from participants at baseline within two weeks prior to first exposure, and at the following time points for each exposure: immediately after exiting the exposure chamber, and at 24 hours after the exposure.
The IL-8 concentration will be determined in each ELF sample by immunoassay. The change in IL-8 concentrations from baseline to immediately Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3 to determine the effect of ozone on the production of nasal IL-8.
Measured: Baseline, immediately post-exposure
Interleukin-8 (IL-8) Concentrations in Nasal Epithelial Lining Fluid (ELF): Change 24 Hours Post-Exposure From Baseline
Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Nasal epithelial lining (ELF) will be collected from participants at baseline within two weeks prior to first exposure, and at the following time points for each exposure: immediately after exiting the exposure chamber, and at 24 hours after the exposure.
The IL-8 concentration will be determined in each ELF sample by immunoassay. The change in IL-8 concentrations from baseline to 24 hours Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3 to determine the effect of ozone on the production of nasal IL-8.
Measured: Baseline, 24 hours post-exposure
Left Ventricular Strain (LVS): Change Immediately Post-Exposure From Baseline
Left ventricular strain will be assessed at baseline prior to exposure (within two weeks), and immediately after the exposure by measuring global longitudinal strain (GLS), an echocardiographic measure of myocardial mechanics. GLS is measured using speckle tracking, a technique by which small myocardial footprints, or speckles, are tracked over the cardiac cycle to enable quantification of left ventricular systolic function. GLS is more sensitive than traditional measures of ventricular function, such as ejection fraction, in detecting clinically inapparent but prognostically important decrements in contractility. The change in global longitudinal strain will be calculated to determine the effect of ozone on left ventricular strain.
Measured: Baseline and immediately post-exposure
Nasal Epithelial Cell IL-1 Beta Gene Expression: Relative mRNA Counts Immediately Post-Exposure (Baseline-corrected), Ozone vs Filtered Air
RNA isolated from nasal epithelial cell biopsies collected at the screening visit (baseline) within six weeks prior to the first exposure and immediately after each exposure. RNA will be analyzed via real-time quantitative polymerase chain reaction (qPCR) to determine the impact of O3 on inflammatory gene expression.
Measured: Screening visit and immediately post-exposure
Flow Mediated Dilation (FMD): Change Immediately Post-Exposure From Baseline
Participants will undergo assesment of flow-mediated brachial artery dilation by brachial ultrasound at baseline prior to exposure (within two weeks), and immediately after exposure to either FA or O3 to assess the impact of O3 exposure on endothelial function. Flow mediated dilation of the brachial artery (FMD) is a noninvasive index of vascular endothelial function. FMD is measured using high-frequency ultrasound, and is expressed as the percent change in arterial diameter in response to the reactive hyperemia induced by 5 minutes of forearm ischemia. Impaired endothelial function leads to atherosclerosis and is associated with an increased risk of cardiovascular events.
Measured: Baseline and immediately post-exposure
Change in Heart Rate Variability
Measure was not performed as the equipment (ECG leads and monitor recording heart rate and rhythm) belonged to the EPA and was not made available for this study
Measured: baseline, immediately post exposure
Nasal Epithelial Cell IL-6R Gene Expression: Relative mRNA Counts Immediately Post-Exposure (Baseline-corrected), Ozone vs Filtered Air
RNA isolated from nasal epithelial cell biopsies collected at the screening visit (baseline) within six weeks prior to the first exposure and immediately after each exposure. RNA will be analyzed via real-time quantitative polymerase chain reaction (qPCR) to determine the impact of O3 on inflammatory gene expression.
Measured: Screening visit and immediately post-exposure
Nasal Epithelial Cell IL-8 Gene Expression: Relative mRNA Counts Immediately Post-Exposure (Baseline-corrected), Ozone vs Filtered Air
RNA isolated from nasal epithelial cell biopsies collected at the screening visit (baseline) within six weeks prior to the first exposure and immediately after each exposure. RNA will be analyzed via real-time quantitative polymerase chain reaction (qPCR) to determine the impact of O3 on inflammatory gene expression.
Measured: Screening visit and immediately post-exposure
The Percentage of Predicted Forced Vital Capacity (% Predicted FVC): Change Immediately Post-Exposure From Baseline
Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Standard spirometry to obtain FEV1 and forced vital capacity (FVC) measurements will be done at baseline within two weeks prior to first exposure, and immediately after exiting the exposure chamber for each exposure. The % Predicted FVC will be calculated from measured versus expected values. The change in % Predicted FVC from baseline to immediately Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3 to determine the effect of ozone on the % Predicted FVC.
Measured: Baseline, immediately post-exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study start22 Apr 2017
- Primary completion1 May 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Environmental ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Environmental Protection Agency (EPA)
- Responsible party
- Sponsor
- Investigators
- David B Peden, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857283
- Sponsor's protocol ID
- 15-2677
- Acronym
- SNOZ
- Status last verified
- May 2021
- First submitted
- 27 Jun 2016
- Last updated
- 14 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Peden DB, Setzer RW Jr, Devlin RB. Ozone exposure has both a priming effect on allergen-induced responses and an intrinsic inflammatory action in the nasal airways of perennially allergic asthmatics. Am J Respir Crit Care Med. 1995 May;151(5):1336-45. doi: 10.1164/ajrccm.151.5.7735583.
PubMed 7735583Little, R. J. and Rubin, D. B. (2014). Statistical analysis with missing data. John Wiley & Sons.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Biological Responses to Low Level Ozone
- ClinicalTrials.gov ID
- NCT02857283
- Acronym / sponsor ID
- SNOZ / 15-2677
- Conditions
- Environmental Exposure, Nasal Inflammation
- Keywords
- Air pollution, Air pollutant exposure, Ozone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Environmental Protection Agency (EPA)
- Study start
- 22 Apr 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Posted 14 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate if low level ozone exposure will cause measurable inflammation in nasal cells.
Detailed description
Air pollutants including ozone have been implicated in affecting health outcomes. In particular, high level ozone exposure has been shown to affect pulmonary function and cause pulmonary inflammation. Troubling community-based work has implicated high ozone levels as being correlated with increased pediatric asthma emergency room visits. Because of adverse health effects, EPA standards for safe ozone levels have been set, currently at 0.07 ppm. Still, it is estimated that 100 million Americans live in areas where ozone levels periodically remain above the EPA standard. And while this EPA standard had been set based on available data, it remained unclear at the time whether naturalistic low-level ozone exposure, such as fluctuations between 0.06-0.08 ppm throughout the day, might affect health as well.
This group previously examined lung function and inflammatory response in adults exposed to low-level ozone, 0.06 ppm exposure for 6.6 hours, while undergoing intermittent moderate exercise. The investigators found that in response to low-level ozone exposure (0.06 ppm) with exercise, lung function declines and neutrophilic airway inflammation is observed. What remains unclear, is whether low-level ozone alone - without exercise - will cause similar health effects.
To mimic exposure to ozone on a typical summer day in a polluted city, the investigators will expose subjects to a varying level of ozone, form 0.06 ppm to 0.08 ppm, rather than a constant 0.07ppm. The variation from 0.06ppm to 0.08ppm, then back to 0.06ppm will occur each hour.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filtered Air, then Ozone | Experimental | Other: Ozone, Other: Filtered Air, Device: Health and Exposure Tracker (HET)Participants in this arm will first receive filtered clean air followed by ozone |
| Ozone, then Filtered Air | Experimental | Other: Ozone, Other: Filtered Air, Device: Health and Exposure Tracker (HET)Participants in this arm will first receive ozone followed by filtered clean air |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males and females between 18 and 50 years of age.
- Vital signs within normal limits on admission to the study: Peripheral oxygen saturation (SpO2) > 94%, systolic blood pressure between 150-90 mm Hg, diastolic blood pressure between 100-60 mm Hg, afebrile.
- Forced Expiratory Volume (FEV1) of at least 80% of predicted.
Key exclusion criteria (5 listed)
- Any chronic medical condition considered by the PI as a contraindication to the exposure study, including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, chronic thyroid disease, or kidney disease.
- Use of systemic or inhaled steroids.
- Use of NSAID or aspirin within 7days of each study visit, and inability to withhold these medications prior to each session of the study.
- Pregnant or nursing women
- Use of cigarettes or other inhaled nicotine products within the past year, or more than a lifetime 5 pack year history of cigarette smoking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OzoneParticipants will be exposed to a concentration of ozone for 6.5 hours at a concentration that varies 0.06 to 0.08 | Other | Filtered Air, then Ozone, Ozone, then Filtered Air |
| Filtered AirParticipants will be exposed to filtered clean air | Other | Filtered Air, then Ozone, Ozone, then Filtered Air |
| Health and Exposure Tracker (HET)Ozone and heart rate tracker | Device | Filtered Air, then Ozone, Ozone, then Filtered Air |
Primary outcome
Change in % Polymorphonuclear Leukocytes (PMN) in Nasal Lavage Fluid Immediately Post-Exposure From Baseline
Time frame: Baseline, immediately post-exposure
Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Nasal lavage fluid (NLF) will be collected from participants at a baseline visit within two weeks prior to each exposure, and at the following time points for each exposure: immediately after exiting the exposure chamber, and at 24 hours after the exposure. The % PMN as a percentage of total inflammatory cells (total of monocytes and macrophages, PMN, eosinophils, basophils, lymphocytes, and bronchial epithelial cells) will be determined in each NLF collection by differential counts of cells on cytospin slides. The change in the values from baseline to immediately Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3.
Change in % Polymorphonuclear Leukocytes (PMN) in Nasal Lavage Fluid 24 Hours Post-Exposure From Baseline
Time frame: Baseline, 24 hours post-exposure
Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Nasal lavage fluid (NLF) will be collected from participants at a baseline visit within two weeks prior to each exposure, and at the following time points for each exposure: immediately after exiting the exposure chamber, and at 24 hours after the exposure. The % PMN as a percentage of total inflammatory cells (total of monocytes and macrophages, PMN, eosinophils, basophils, lymphocytes, and bronchial epithelial cells) will be determined in each NLF collection by differential counts of cells on cytospin slides. The change in the values from baseline to 24 hours Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3.
13 secondary outcomes
Interleukin-6 (IL-6) Concentrations in Nasal Epithelial Lining Fluid (ELF): Change Immediately Post-Exposure From Baseline
Time frame: Baseline, immediately post-exposure
% Polymorphonuclear Leukocytes (PMN) in Induced Sputum: Change 24 Hours Post-Exposure From Screening Visit
Time frame: Screening visit and 24 hours post-exposure
The Percentage of Predicted Forced Expiratory Volume in One Second (% Predicted FEV1): Change Immediately Post-Exposure From Baseline
Time frame: Baseline, immediately post-exposure
Interleukin-6 (IL-6) Concentrations in Nasal Epithelial Lining Fluid (ELF): Change 24 Hours Post-Exposure From Baseline
Time frame: Baseline, 24 hours post-exposure
Interleukin-8 (IL-8) Concentrations in Nasal Epithelial Lining Fluid (ELF): Change Immediately Post-Exposure From Baseline
Time frame: Baseline, immediately post-exposure
Interleukin-8 (IL-8) Concentrations in Nasal Epithelial Lining Fluid (ELF): Change 24 Hours Post-Exposure From Baseline
Time frame: Baseline, 24 hours post-exposure
Left Ventricular Strain (LVS): Change Immediately Post-Exposure From Baseline
Time frame: Baseline and immediately post-exposure
Nasal Epithelial Cell IL-1 Beta Gene Expression: Relative mRNA Counts Immediately Post-Exposure (Baseline-corrected), Ozone vs Filtered Air
Time frame: Screening visit and immediately post-exposure
Flow Mediated Dilation (FMD): Change Immediately Post-Exposure From Baseline
Time frame: Baseline and immediately post-exposure
Change in Heart Rate Variability
Time frame: baseline, immediately post exposure
Nasal Epithelial Cell IL-6R Gene Expression: Relative mRNA Counts Immediately Post-Exposure (Baseline-corrected), Ozone vs Filtered Air
Time frame: Screening visit and immediately post-exposure
Nasal Epithelial Cell IL-8 Gene Expression: Relative mRNA Counts Immediately Post-Exposure (Baseline-corrected), Ozone vs Filtered Air
Time frame: Screening visit and immediately post-exposure
The Percentage of Predicted Forced Vital Capacity (% Predicted FVC): Change Immediately Post-Exposure From Baseline
Time frame: Baseline, immediately post-exposure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7735583Peden DB, Setzer RW Jr, Devlin RB. Ozone exposure has both a priming effect on allergen-induced responses and an intrinsic inflammatory action in the nasal airways of perennially allergic asthmatics. Am J Respir Crit Care Med. 1995 May;151(5):1336-45. doi: 10.1164/ajrccm.151.5.7735583.
- BackgroundLittle, R. J. and Rubin, D. B. (2014). Statistical analysis with missing data. John Wiley & Sons.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David B Peden, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozone, Filtered Air and Health and Exposure Tracker (HET) in people with Environmental Exposure and Nasal Inflammation, run by University of North Carolina, Chapel Hill 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 14 May 2021. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in % Polymorphonuclear Leukocytes (PMN) in Nasal Lavage Fluid Immediately Post-Exposure From Baseline (time frame: Baseline, immediately post-exposure). The study lists 2 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 NCT02857283, which also lists 2 linked publications.
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 14 May 2021.