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

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ClinicalTrials.gov Identifier: NCT03599206
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Environmental and Genetic Factors on Lung Function Drug: Ozone Other: Filtered Air Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: CXCL10/CXCR3 Regulation of Ozone-Induced Epithelial Permeability
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ozone

Arm Intervention/treatment
Experimental: Ozone Drug: Ozone
Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).

Placebo Comparator: Filtered Air Other: Filtered Air
Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air.




Primary Outcome Measures :
  1. Change in Ozone (O3) induced epithelial permeability, as measured by the level of clara cell secretory protein (ng/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 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. Each value will be compared to the individuals filtered air control and reported as a fold change from baseline. These are independent values but are both accepted in the literature as measures of epithelial permeability.

  2. 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. Each value will be compared to the individuals filtered air control and reported as a fold change from baseline. These are independent values but are both accepted in the literature as measures of epithelial permeability.


Secondary Outcome Measures :
  1. 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

  2. Change in Ozone O3 induced alterations in bronchoalveolar lavage cytokines and growth factors [ Time Frame: Baseline, 21 days ]
    Measured by multiplex ELISA



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 > 35 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599206


Contacts
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Contact: Catherine Foss 1-919-479-0861 catherine.foss@dm.duke.edu

Locations
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United States, North Carolina
Duke Asthma, Allergy, and Airway Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Catherine Foss    919-479-0861    catherine.foss@dm.duke.edu   
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Robert Tighe, MD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03599206     History of Changes
Other Study ID Numbers: Pro00088966
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Duke University:
genetic: CXCR3 polymorphism rs2280964