Environmental and Genetic Factors on Lung FunctionEarly Phase 1NCT03599206
ONES Grant: CXCL10/CXCR3 Regulation of Ozone-Induced Epithelial Permeability
A Early Phase 1 study testing Ozone and Filtered Air in people with Environmental and Genetic Factors on Lung Function, run by Robert Tighe, MD at 1 site in United States.
Trial summary
The purpose of this research study to understand how environmental and genetic factors may be involved in lung function. Study participants will undergo a 1-day screening that includes a blood draw and breathing testing, return for a two-day series of testing to include blood draw, and brief breathing test before and… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Environmental and Genetic Factors on Lung Function
- What is being tested?
- Ozone and Filtered Air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2019to 24 Jan 2024
- Phase
- Early Phase 1
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Prior enrollment in the NIEHS Environmental Polymorphism Registry located in the greater Raleigh-Durham area
- Wild type or homozygous (female)/hemizygous (male - since sex-linked) expression of the CXCR3 polymorphism rs2280964
Who cannot join
- Current smokers of tobacco products including e-cigarettes or those with previous smoking history within the prior 5 years
- BMI less than 37 kg/m2
- Pregnant women and women who are presently lactating.
- Subjects that have received antibiotic administration or an upper respiratory infection within the previous 4 weeks
- College and graduate students or employees who are under direct supervision by any of the investigators in this protocol
- Alcohol or illicit substance abuse
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- Chronic cardio/pulmonary respiratory disorders or other medical conditions as determined by the investigator
- Increased airway hyperresponsiveness at baseline as measured by a positive methacholine challenge response (methacholine PC20 FEV1 < 8 mg/ml)
- Subjects will be requested to refrain from antihistamines, nonsteroidal anti-inflammatory agents, antioxidants (e.g. beta-carotene, selenium, and lutein) and supplemental vitamins (e.g. C and E), for 1 week prior to, and during testing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Asthma, Allergy, and Airway Center
Durham, North Carolina, 27705
About this study
Official title: CXCL10/CXCR3 Regulation of Ozone-Induced Epithelial Permeability
The purpose of this research study to understand how environmental and genetic factors may be involved in lung function. Study participants will undergo a 1-day screening that includes a blood draw and breathing testing, return for a two-day series of testing to include blood draw, and brief breathing test before and after an inhaled challenge with either filtered air (FA) or ozone (O3). Participants return the next day for a brief breathing test, a blood draw and a procedure called bronchoscopy to evaluate the lung after the challenge. Participants then return 18 - 20 days later to repeat the two-day series of testing to be challenged with the exposure not received on the first series, (FA or O3). Each visit will take about 3 - 3.5 hours. Follow-up phone calls from the study team will occur at 24 hours after each 2-day test series. Total study duration is about one to one-and a half months.
- Being tested
- Ozone, Filtered Air
- Keywords
- genetic: CXCR3 polymorphism rs2280964
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzoneDrug
Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).
Filtered AirOther
Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air.
| Study group | Role | What they receive |
|---|---|---|
| Ozone | Experimental | Not described Receives: Drug: Ozone |
| Filtered Air | Placebo comparator | Not described Receives: Other: Filtered Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ozone (O3) Induced Epithelial Permeability, as Measured by the Level of Clara Cell Secretory Protein
This measure is defined by the comparing each individuals baseline (following filtered air challenge) to the ozone response. The investigators will perform two tests on this response as a means of confirmation. The individual will have blood drawn to obtain serum and a bronchoscopy to obtain bronchoalveolar lavage. The serum will be used to determine the level of clara cell secretory protein. This is measured by enzyme-linked immunosorbent assay (ELISA). The value is reported as ng/mL.
Measured: Baseline, 21 days
Change in Ozone (O3) Induced Epithelial Permeability, as Measured by Albumin Level (ug/mL)
This measure is defined by the comparing each individuals baseline (following filtered air challenge) to the ozone response. The investigators will perform two tests on this response as a means of confirmation. The individual will have blood drawn to obtain serum and a bronchoscopy to obtain bronchoalveolar lavage. The bronchoalveolar lavage will be similarly used to define the albumin level. Albumin is also measured by ELISA. The value is reported at ug/mL.
Measured: Baseline, 21 days
Secondary outcomes (5)
Change in Ozone O3 Induced Alterations in Gene Expression of Airway Epithelial Cells, and Bronchoalveolar Lavage Cells
Measured by real-time PCR
Measured: Baseline, 21 days
Change in Ozone (O3) Induced Bronchoalveolar Lavage CXCL11 Levels
CXCL11, or C-X-C motif chemokine 11, is a protein that acts as a chemoattractant and plays a role in regulating cell migration. Measured by multiplex ELISA.
Measured: Baseline, 21 days
Change in Ozone (O3) Induced Bronchoalveolar Lavage CXCL10 Levels
CXCL10 is a cytokine that has multiple roles, such as modulating innate and adaptive immune response, regulating cell growth and angiostatic effects. Measured by multiplex ELISA.
Measured: Baseline, 21 days
Change in Ozone (O3) Induced Bronchoalveolar Lavage IFN-γ Levels
Interferon-gamma (IFN-γ) is a cytokine that plays an important role in inducing and modulating an array of immune responses. Measured by multiplex ELISA.
Measured: Baseline, 21 days
Change in Ozone (O3) Induced Bronchoalveolar Lavage CXCL9 Levels
CXCL9, or C-X-C motif chemokine ligand 9, is a small cytokine that plays a role in inflammation, tumor growth, and other processes. Measured by multiplex ELISA.
Measured: Baseline, 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start16 Aug 2019
- Primary completion29 Nov 2023
- Study completion24 Jan 2024
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.
- Other trials for Environmental and Genetic Factors on Lung FunctionStudies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Tighe, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Tighe, MD, Duke University
- Investigators
- Robert Tighe, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599206
- Sponsor's protocol ID
- Pro00088966
- Status last verified
- Jun 2026
- First submitted
- 3 Jul 2018
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CXCL10/CXCR3 Regulation of Ozone-Induced Epithelial Permeability
- ClinicalTrials.gov ID
- NCT03599206
- Acronym / sponsor ID
- Pro00088966
- Keywords
- genetic: CXCR3 polymorphism rs2280964
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Robert Tighe, MDUniversity, hospital or other
- Study start
- 16 Aug 2019 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 15 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study to understand how environmental and genetic factors may be involved in lung function. Study participants will undergo a 1-day screening that includes a blood draw and breathing testing, return for a two-day series of testing to include blood draw, and brief breathing test before and after an inhaled challenge with either filtered air (FA) or ozone (O3). Participants return the next day for a brief breathing test, a blood draw and a procedure called bronchoscopy to evaluate the lung after the challenge. Participants then return 18 - 20 days later to repeat the two-day series of testing to be challenged with the exposure not received on the first series, (FA or O3). Each visit will take about 3 - 3.5 hours. Follow-up phone calls from the study team will occur at 24 hours after each 2-day test series. Total study duration is about one to one-and a half months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozone | Experimental | Drug: Ozone |
| Filtered Air | Placebo comparator | Other: Filtered Air |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Prior enrollment in the NIEHS Environmental Polymorphism Registry located in the greater Raleigh-Durham area
- Wild type or homozygous (female)/hemizygous (male - since sex-linked) expression of the CXCR3 polymorphism rs2280964
Key exclusion criteria (9 listed)
- Current smokers of tobacco products including e-cigarettes or those with previous smoking history within the prior 5 years
- BMI less than 37 kg/m2
- Pregnant women and women who are presently lactating.
- Subjects that have received antibiotic administration or an upper respiratory infection within the previous 4 weeks
- College and graduate students or employees who are under direct supervision by any of the investigators in this protocol
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 |
|---|---|---|
| OzoneSubjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3). | Drug | Ozone |
| Filtered AirSubjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air. | Other | Filtered Air |
Primary outcome
Change in Ozone (O3) Induced Epithelial Permeability, as Measured by the Level of Clara Cell Secretory Protein
Time frame: Baseline, 21 days
This measure is defined by the comparing each individuals baseline (following filtered air challenge) to the ozone response. The investigators will perform two tests on this response as a means of confirmation. The individual will have blood drawn to obtain serum and a bronchoscopy to obtain bronchoalveolar lavage. The serum will be used to determine the level of clara cell secretory protein. This is measured by enzyme-linked immunosorbent assay (ELISA). The value is reported as ng/mL.
Change in Ozone (O3) Induced Epithelial Permeability, as Measured by Albumin Level (ug/mL)
Time frame: Baseline, 21 days
This measure is defined by the comparing each individuals baseline (following filtered air challenge) to the ozone response. The investigators will perform two tests on this response as a means of confirmation. The individual will have blood drawn to obtain serum and a bronchoscopy to obtain bronchoalveolar lavage. The bronchoalveolar lavage will be similarly used to define the albumin level. Albumin is also measured by ELISA. The value is reported at ug/mL.
5 secondary outcomes
Change in Ozone O3 Induced Alterations in Gene Expression of Airway Epithelial Cells, and Bronchoalveolar Lavage Cells
Time frame: Baseline, 21 days
Change in Ozone (O3) Induced Bronchoalveolar Lavage CXCL11 Levels
Time frame: Baseline, 21 days
Change in Ozone (O3) Induced Bronchoalveolar Lavage CXCL10 Levels
Time frame: Baseline, 21 days
Change in Ozone (O3) Induced Bronchoalveolar Lavage IFN-γ Levels
Time frame: Baseline, 21 days
Change in Ozone (O3) Induced Bronchoalveolar Lavage CXCL9 Levels
Time frame: Baseline, 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Robert Tighe, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ozone and Filtered Air in people with Environmental and Genetic Factors on Lung Function, run by Robert Tighe, MD 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 2 inclusion and 9 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 15 Jun 2026. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2026). 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 Ozone (O3) Induced Epithelial Permeability, as Measured by the Level of Clara Cell Secretory Protein (time frame: Baseline, 21 days). 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?
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 15 Jun 2026.