Completed

NCT Number: NCT03599206

ONES Grant: 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.

Completed

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Key information

Conditions

Environmental and Genetic Factors on Lung Function

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Duke Asthma, Allergy, and Airway Center

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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
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.

Treatment and study plan

Ozone

Drug

Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).

Filtered Air

Other

Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air.

Primary outcomes

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.

Secondary outcomes

Change in Ozone O3 Induced Alterations in Gene Expression of Airway Epithelial Cells, and Bronchoalveolar Lavage Cells

Time frame: Baseline, 21 days

Measured by real-time PCR
Change in Ozone (O3) Induced Bronchoalveolar Lavage CXCL11 Levels

Time frame: Baseline, 21 days

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.
Change in Ozone (O3) Induced Bronchoalveolar Lavage CXCL10 Levels

Time frame: Baseline, 21 days

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.
Change in Ozone (O3) Induced Bronchoalveolar Lavage IFN-γ Levels

Time frame: Baseline, 21 days

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.
Change in Ozone (O3) Induced Bronchoalveolar Lavage CXCL9 Levels

Time frame: Baseline, 21 days

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.

Sponsors and collaborators

Lead sponsor

Robert Tighe, MD

Other

Registry information

Official study title

CXCL10/CXCR3 Regulation of Ozone-Induced Epithelial Permeability

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2024
First posted: Jul 26, 2018
Registry last updated: Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.