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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.
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| Name | Class |
|---|---|
| Environmental Protection Agency (EPA) | FED |
| North Carolina State University | OTHER |
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To determine if low levels of ozone (O3) encountered on a typical day in Chapel Hill will decrease spirometric values in mild asthmatics.
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 Protection Agency (EPA) has determined that there is a causal relationship, and even lowered the 8-hour exposure standard to 0.07 parts per million (ppm) in 2015. Controlled human exposure studies and epidemiological studies have consistently observed ozone-associated decrements in lung function and increased respiratory symptoms. Most controlled human exposure studies have been performed with high ozone concentrations. Additionally, epidemiologic studies have focused on populations engaged in outdoor activities (increasing ozone exposure through increased minute ventilation), or in cities such as Los Angeles or Mexico City where ambient ozone levels are especially high. Evidence has recently emerged that exposure to low ozone concentrations also produces adverse health effects, especially among susceptible groups including children with asthma.
The objective of this study is to examine if low level ozone exposure (compared to a clean air exposure), reflective of a typical metropolitan summer day, will cause decrements in lung function and measurable upper and lower airway inflammation in mild asthmatics (who are not on asthma controller medications) while performing typical daily activities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6 hour Filtered Air (FA) followed by O3 exposure | Experimental | For the first exposure session, participants are exposed to filtered air (FA) for 6 hours. For the second exposure session, the same participant will be exposed to ozone at a concentration of 0.07ppm for 6 hours. |
|
| 6 hour O3 exposure followed by FA exposure | Experimental | For the first exposure session, a participant will be exposed to ozone at a concentration of 0.07ppm for 6 hours. For the second exposure session, the same participant will be exposed to FA for 6 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozone | Other | ozone exposure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Percent eosinophils in induced sputum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Peden, MD | UNC SOM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina CEMALB | Chapel Hill | North Carolina | 27599 | United States |
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
9 to 36 months following publication
Approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D010126 | Ozone |
| ID | Term |
|---|---|
| D010100 | Oxygen |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
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| FA | Other | Filtered air exposure |
|
% eosinophils in induced sputum (24 hrs post ozone - post air)
| 24 hours post-O3 versus post-air exposure |
| 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 |
| 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 |
| 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 |
| 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 |
| Change in Cytokine concentrations in Nasal Epithelial Lining Fluid (NELF) | Cytokine via Mesoscale in NELF | 6 hours post-O3 versus post-air exposure |
| 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 |
| 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 |
| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |