ONES Grant: CXCL10/CXCR3 Regulation of Ozone-Induced Epithelial Permeability

NCT ID: NCT03599206

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-16
• Study Completion Date: 2024-01-24

Brief 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 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.

Conditions

Environmental and Genetic Factors on Lung Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Ozone

Group Type: EXPERIMENTAL

Ozone

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

Filtered Air

Intervention Type: OTHER

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

Interventions

Ozone

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

Intervention Type: DRUG

Filtered Air

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Robert Tighe, MD

OTHER

Sponsor Role: lead

Responsible Party

Robert Tighe, MD

Associate Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Robert Tighe, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Asthma, Allergy, and Airway Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00088966

Identifier Type: -

Identifier Source: org_study_id