Effects of Low Dose Ozone on Airway Inflammatory Responses in Adults With Asthma - Sedentary Nasa… (NCT04109807) | Clinical Trial Compass
SuspendedNot Applicable
Effects of Low Dose Ozone on Airway Inflammatory Responses in Adults With Asthma - Sedentary Nasal Ozone (Asthma SNOZ)
Stopped: Enrollment for this study was stopped due to Covid and will resume once it is determined acceptable to do inhalational challenges. rebuilding chambers after EPA was shut down.
United States18 participantsStarted 2019-12-16
Plain-language summary
To determine if low levels of ozone (O3) encountered on a typical day in Chapel Hill will decrease spirometric values in mild asthmatics.
Who can participate
Age range18 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 exerc…
What they're measuring
1
Change in Percent (%) predicted forced expiratory volume at one second (FEV1)
Timeframe: 6 hours post-O3 versus post-air exposure versus pre-exposure