Status:
SUSPENDED
Effects of Low Dose Ozone on Airway Inflammatory Responses in Adults With Asthma - Sedentary Nasal Ozone (Asthma SNOZ)
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Environmental Protection Agency (EPA)
North Carolina State University
Conditions:
Asthma, Allergic
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
To determine if low levels of ozone (O3) encountered on a typical day in Chapel Hill will decrease spirometric values in mild asthmatics.
Detailed Description
Short-term exposure to ambient air ozone has been recognized for decades to be adversely associated with impacts on the respiratory system. Indeed the evidence is such that the Environmental Protectio...
Eligibility Criteria
Inclusion
- Ages 18-45, both sexes included
- Mild intermittent asthma, defined as daytime asthma symptoms no more than 2 times per week, night time asthma symptoms no more than 2 times per month, FEV1 \>80% of predicted, and asthma exacerbation requiring oral steroids 1 time or less per year.
- Good general health as evidenced by medical history
- Vital signs will be within normal limits on admission to the study: oxygen saturation by pulse oximetry (SpO2) \> 94%, systolic blood pressure between 150-90 mm Hg, diastolic blood pressure between 100-60 mm Hg, afebrile.
- FEV1 of at least 80% of predicted at baseline
- Able to provide informed consent
- Proof of Covid Vaccination
Exclusion
- Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections/immunodeficiency, history of tuberculosis
- Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months
- Orthopedic injuries or impediments that would preclude bicycle or treadmill exercise
- Viral upper respiratory tract infection within 4 weeks of challenge.
- Any acute infection requiring antibiotics within 4 weeks of exposure or fever of unknown origin within 2 weeks of challenge.
- Individuals who use daily controller medication for asthma. Pre-treatment with a short acting bronchodilator prior to exercise is allowed.
- Nasal surgery within 6 months
- Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
- Any recent or current use of nicotine
- History of intubation for asthma
- Pregnancy or nursing an infant as EPA strictly prohibits intentional exposure for research to this population.
- Covid infection in the past 90 days
Key Trial Info
Start Date :
December 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04109807
Start Date
December 16 2019
End Date
August 1 2027
Last Update
December 17 2025
Active Locations (1)
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1
University of North Carolina CEMALB
Chapel Hill, North Carolina, United States, 27599