Asthma, Allergic Clinical Trial
Official title:
Effects of Low Dose Ozone on Airway Inflammatory Responses in Adults With Asthma Asthma SNOZ
NCT number | NCT04109807 |
Other study ID # | 18-2425 |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | December 16, 2019 |
Est. completion date | October 2024 |
Verified date | October 2023 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine if low levels of ozone (O3) encountered on a typical day in Chapel Hill will decrease spirometric values in mild asthmatics.
Status | Suspended |
Enrollment | 18 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina CEMALB | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Environmental Protection Agency (EPA), North Carolina State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Percent (%) predicted forced expiratory volume at one second (FEV1) | Change from baseline %predicted FEV1 post-O3 versus post-air exposure. | 6 hours post-O3 versus post-air exposure versus pre-exposure | |
Secondary | Change in Percent (%) predicted forced vital capacity (FVC) | Change from baseline %predicted FVC post-O3 versus post-air exposure. | 6 hours post-O3 versus post-air exposure versus pre-exposure | |
Secondary | Change in Percent eosinophils in induced sputum | % eosinophils in induced sputum (24 hrs post ozone - post air) | 24 hours post-O3 versus post-air exposure | |
Secondary | Change in Percent (%) neutrophils in induced sputum | % neutrophils in induced sputum (24 hrs post ozone - post air) | 24 hours post-O3 versus post-air exposure | |
Secondary | Change in Eosinophils per mg of induced sputum | Eosinophils per mg of induced sputum (24 hrs post ozone - post air) | 24 hours post-O3 versus post-air exposure | |
Secondary | Change in neutrophils per mg of induced sputum | Neutrophils per mg of induced sputum (24 hrs post ozone - post air) | 24 hours post-O3 versus post-air exposure | |
Secondary | Change in Cytokine concentrations in induced sputum picograms per milliliter (pg/mL) | Cytokine and via Mesoscale in induced sputum (pg/mL) | 24 hours post-O3 versus post-air exposure | |
Secondary | Change in Cytokine concentrations in Nasal Epithelial Lining Fluid (NELF) | Cytokine via Mesoscale in NELF | 6 hours post-O3 versus post-air exposure | |
Secondary | Change in Change in cytokine concentrations in Nasal Epithelial Lining Fluid (NELF) | Cytokine and via Mesoscale in NELF | 24 hours post-O3 versus post-air exposure | |
Secondary | Change in Fraction of Exhaled Nitric Oxide (FENO) levels in parts per billion (PPB) | Changes in FeNO levels in ppb (6 hours post ozone - post air) | 6 post-O3 post-air exposure versus pre-exposure | |
Secondary | Change in FENO levels in parts per billion (PPB) | Changes in FeNO levels in ppb (24 hours post ozone - post air) | 24 hours post-O3 versus post-air exposure |
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