Mechanisms of Ozone-Induced Alterations in Efferocytosis and Phagocytosis
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 3/9/2019 |
| Start Date: | February 19, 2019 |
| End Date: | January 31, 2024 |
| Contact: | Catherine Foss |
| Email: | catherine.foss@dm.duke.edu |
| Phone: | 919-613-7627 |
The purpose of this research study to understand how environmental and genetic factors may be
involved in lung function. Healthy 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 performed under conscious
sedation 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.
involved in lung function. Healthy 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 performed under conscious
sedation 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.
Inclusion Criteria
• Individuals between 18-35 yrs. of age (No subject will be excluded from the study on the
basis of gender or ethnicity)
Exclusion Criteria
- Current smokers of tobacco products including e-cigarettes or those with previous
smoking history within the prior 5 years
- 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.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Robert Tigher, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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