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The purpose of this research study to understand how environmental and genetic factors may be involved in lung function. 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozone | Experimental |
| |
| Filtered Air | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozone | Drug | Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ozone (O3) Induced Epithelial Permeability, as Measured by the Level of Clara Cell Secretory Protein | This measure is defined by the comparing each individuals baseline (following filtered air challenge) to the ozone response. The investigators will perform two tests on this response as a means of confirmation. The individual will have blood drawn to obtain serum and a bronchoscopy to obtain bronchoalveolar lavage. The serum will be used to determine the level of clara cell secretory protein. This is measured by enzyme-linked immunosorbent assay (ELISA). The value is reported as ng/mL. | Baseline, 21 days |
| Change in Ozone (O3) Induced Epithelial Permeability, as Measured by Albumin Level (ug/mL) | This measure is defined by the comparing each individuals baseline (following filtered air challenge) to the ozone response. The investigators will perform two tests on this response as a means of confirmation. The individual will have blood drawn to obtain serum and a bronchoscopy to obtain bronchoalveolar lavage. The bronchoalveolar lavage will be similarly used to define the albumin level. Albumin is also measured by ELISA. The value is reported at ug/mL. | Baseline, 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ozone O3 Induced Alterations in Gene Expression of Airway Epithelial Cells, and Bronchoalveolar Lavage Cells | Measured by real-time PCR | Baseline, 21 days |
| Change in Ozone (O3) Induced Bronchoalveolar Lavage CXCL11 Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Tighe, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Asthma, Allergy, and Airway Center | Durham | North Carolina | 27705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ozone, Then Filtered Air | Ozone: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3). Filtered Air: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air. |
| FG001 | Filtered Air, Then Ozone | Filtered Air: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air. Ozone: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants received both exposures.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ozone and Filtered Air | Ozone: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3). Filtered Air: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Geometric Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Ozone (O3) Induced Epithelial Permeability, as Measured by the Level of Clara Cell Secretory Protein | This measure is defined by the comparing each individuals baseline (following filtered air challenge) to the ozone response. The investigators will perform two tests on this response as a means of confirmation. The individual will have blood drawn to obtain serum and a bronchoscopy to obtain bronchoalveolar lavage. The serum will be used to determine the level of clara cell secretory protein. This is measured by enzyme-linked immunosorbent assay (ELISA). The value is reported as ng/mL. | Each participant completed both exposures. | Posted | Mean | Standard Deviation | ng/mL | Baseline, 21 days |
|
Screening visit through second bronchoscopy, up to 21 days
All participants received both exposures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ozone and Filtered Air | Ozone: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3). Filtered Air: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert M. Tighe, MD | Duke University | 919-684-4894 | robert.tighe@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2021 | Nov 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010126 | Ozone |
| ID | Term |
|---|---|
| D010100 | Oxygen |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
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| Filtered Air | Other | Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air. |
|
CXCL11, or C-X-C motif chemokine 11, is a protein that acts as a chemoattractant and plays a role in regulating cell migration. Measured by multiplex ELISA.
| Baseline, 21 days |
| Change in Ozone (O3) Induced Bronchoalveolar Lavage CXCL10 Levels | CXCL10 is a cytokine that has multiple roles, such as modulating innate and adaptive immune response, regulating cell growth and angiostatic effects. Measured by multiplex ELISA. | Baseline, 21 days |
| Change in Ozone (O3) Induced Bronchoalveolar Lavage IFN-γ Levels | Interferon-gamma (IFN-γ) is a cytokine that plays an important role in inducing and modulating an array of immune responses. Measured by multiplex ELISA. | Baseline, 21 days |
| Change in Ozone (O3) Induced Bronchoalveolar Lavage CXCL9 Levels | CXCL9, or C-X-C motif chemokine ligand 9, is a small cytokine that plays a role in inflammation, tumor growth, and other processes. Measured by multiplex ELISA. | Baseline, 21 days |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Filtered Air | Filtered Air: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air. |
|
|
| Primary | Change in Ozone (O3) Induced Epithelial Permeability, as Measured by Albumin Level (ug/mL) | This measure is defined by the comparing each individuals baseline (following filtered air challenge) to the ozone response. The investigators will perform two tests on this response as a means of confirmation. The individual will have blood drawn to obtain serum and a bronchoscopy to obtain bronchoalveolar lavage. The bronchoalveolar lavage will be similarly used to define the albumin level. Albumin is also measured by ELISA. The value is reported at ug/mL. | Each participant completed both exposures. | Posted | Mean | Standard Deviation | ug/mL | Baseline, 21 days |
|
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| Secondary | Change in Ozone O3 Induced Alterations in Gene Expression of Airway Epithelial Cells, and Bronchoalveolar Lavage Cells | Measured by real-time PCR | Data not collected due to unavailability of assay. | Posted | Baseline, 21 days |
|
|
| Secondary | Change in Ozone (O3) Induced Bronchoalveolar Lavage CXCL11 Levels | CXCL11, or C-X-C motif chemokine 11, is a protein that acts as a chemoattractant and plays a role in regulating cell migration. Measured by multiplex ELISA. | Each participant completed both exposures. | Posted | Mean | Standard Deviation | pg/mL | Baseline, 21 days |
|
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|
| Secondary | Change in Ozone (O3) Induced Bronchoalveolar Lavage CXCL10 Levels | CXCL10 is a cytokine that has multiple roles, such as modulating innate and adaptive immune response, regulating cell growth and angiostatic effects. Measured by multiplex ELISA. | Each participant completed both exposures. | Posted | Mean | Standard Deviation | pg/mL | Baseline, 21 days |
|
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| Secondary | Change in Ozone (O3) Induced Bronchoalveolar Lavage IFN-γ Levels | Interferon-gamma (IFN-γ) is a cytokine that plays an important role in inducing and modulating an array of immune responses. Measured by multiplex ELISA. | Each participant completed both exposures. | Posted | Mean | Standard Deviation | pg/mL | Baseline, 21 days |
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| Secondary | Change in Ozone (O3) Induced Bronchoalveolar Lavage CXCL9 Levels | CXCL9, or C-X-C motif chemokine ligand 9, is a small cytokine that plays a role in inflammation, tumor growth, and other processes. Measured by multiplex ELISA. | Each participant completed both exposures. | Posted | Mean | Standard Deviation | pg/mL | Baseline, 21 days |
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| 14 |
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| 14 |
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