SUSPENDED

Cardiovascular Effects of Exposure to Wood Smoke in Healthy Human Adults

Conditions

Healthy Healthy subjects Wood smoke Respiratory effects Cardiovascular effects Young

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

MASKOFF Clinical Trials 8/22/23 Brief Summary: Purpose: The study is designed to investigate cardiovascular effects of young healthy human subjects exposed to wood smoke. Participants: Approximately 80 young (18-35 years old) healthy subjects to complete. Procedure (methods): After consenting to participate in the study, subjects will be exposed first to filtered air and on the next exposure day to approximately 500 µg/m\^3 wood smoke. Both exposures will be 2 hours long with alternating 15 min of exercise (cycle ergometer) and 15 min rest period. The exercise level will be adjusted to achieve approximately 20 L/min/m\^2 minute ventilation. Venous blood samples and measurements of lung, cardiac and vascular function will be made prior to and immediately following each exposure. Induced sputum samples and nasal epithelial lining fluid will be collected approximately 24 hours post each exposure.

Official Title

Cardiovascular Effects of Exposure to Wood Smoke in Healthy Human Adults

Quick Facts

Study Start:2021-05-25

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:SUSPENDED

Study ID

NCT04297761

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 35 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18-35 years old , healthy, with a Body Mass Index (BMI, kg/m\^2) values ≥ 19 and ≤ 34, inclusive). 2. Physical conditioning that allows intermittent, mild exercise for approximately 60 min during a 2 hour exposure session. The volunteer must be able to complete the exposure exercise regimen at a workload sufficient to induce a minute ventilation rate of approximately 20 L/min/m\^2 for 15 min without exceeding 80% of projected maximal heart rate. 3. Normal ECG. 4. Normal lung function based on NHANES III reference values. i. Forced vital capacity (FVC) ≥ 80% of that predicted for age, gender, ethnicity, and height. 5. Oxygen saturation greater than 94% at the time of physical exam.	1. Individuals with the following conditions: * A history of acute or chronic cardiovascular disease, chronic respiratory disease, cancer, rheumatologic disease, neuromuscular disease, or immunodeficiency state. * BMI (kg/m\^2) values \< 19 and \> 34. * Blood pressure readings ≥ 140 systolic and/or ≥ 90 diastolic. * Diabetes (previously diagnosed or with hemoglobin A1c level equal to or greater than 6.4%). * Asthma or a history of asthma. * Bleeding/clotting disorders. 2. Individuals with a cardiovascular disease risk score greater than 10% using the ACC/AHA ASCVD risk calculator. (Based on the 10-year risk of heart disease or stroke using the Atherosclerotic Cardiovascular Disease algorithm published in 2013 American College of Cardiology/American Heart Association Guideline on the Assessment of Cardiovascular risk.) 3. Individuals who have unspecified illnesses, which in the judgment of the medical staff might increase the risk associated with wood smoke inhalation will be a basis for exclusion. 4. Individuals who have had recent (within 6 months) abdominal an/or eye surgery, or with any types of hernia, as well as any other contraindicators for raised intra-abdominal pressure. 5. Individuals who are currently taking systemic steroids or oral anticoagulants long term. 6. Individuals who are taking prescribed medications such as ß-blocker medications, that may impact the results of wood smoke challenge for the duration of the study. Other medications not specifically mentioned here may be reviewed by the medical staff prior to an individual's inclusion in the study. Use of other medications will be evaluated on a case-by-case basis. There is the potential that an individual's current medication use will preclude them from participating in the study at the current time, but they may be reassessed and potentially rescheduled for participation later based on the judgement of the medical staff. 7. Individuals who are allergic to: * Chemical vapors or gases. * Tape or electrodes on their skin. * Or individuals with active allergies or currently experience allergy related symptoms 8. Individuals who are pregnant, attempting to become pregnant or breastfeeding. 9. Individuals who are currently smoking (including vaping, hookah and e-cigarette) or have smoking history within 1 year of study or have an equal to greater than or a 5-pack year smoking history. 10. Individuals living with a smoker who smokes inside the house. 11. Individuals who are regularly exposed to high levels of vapors, dust, gases, or fumes. 12. Individuals who do not read, speak, or understand English well enough to give informed consent. 13. Individuals that are unable to perform the exercise required for the study. 14. Individuals who are unwilling or unable to stop taking any current dietary supplements or vitamins for the duration of the study. 15. Individuals currently taking prebiotics, probiotics, or antihistamines. 16. Individuals who have experienced an acute respiratory illness within the last 6 weeks. 17. Individuals that will NOT comply with the following requirements: * Avoid smoke and fumes for 24 hours before all visits. * Avoid exposure to unvented household combustion sources (gas stoves, lit fireplaces, oil/kerosene heaters) for 48 hours before all visits. * Avoid over-the-counter pain medications such as aspirin, Advil, Aleve, or NSAIDs for 48 hours before all visits. * Avoid drinking alcohol 34 hours before all visits * Avoid strenuous exercise for 24 hours prior to an after all visits. * Eat a light breakfast and low-fat lunch on the exposure day. * Refrain from eating pan fried and/or grilled foods 12 hours prior to the exposure days. * Refrain from consuming caffeine for 12 hours prior to all study visits. * Refrain from consuming food 2 hours prior to the consenting and follow up sessions, as this may interfere with induced sputum collection. * Wear a N95 mask during all visits to the HSF. A mask will be provided to participants upon check-in.

Inclusion Criteria

Exclusion Criteria

1. Age 18-35 years old , healthy, with a Body Mass Index (BMI, kg/m\^2) values ≥ 19 and ≤ 34, inclusive).
2. Physical conditioning that allows intermittent, mild exercise for approximately 60 min during a 2 hour exposure session. The volunteer must be able to complete the exposure exercise regimen at a workload sufficient to induce a minute ventilation rate of approximately 20 L/min/m\^2 for 15 min without exceeding 80% of projected maximal heart rate.
3. Normal ECG.
4. Normal lung function based on NHANES III reference values. i. Forced vital capacity (FVC) ≥ 80% of that predicted for age, gender, ethnicity, and height.
5. Oxygen saturation greater than 94% at the time of physical exam.

1. Individuals with the following conditions:
* A history of acute or chronic cardiovascular disease, chronic respiratory disease, cancer, rheumatologic disease, neuromuscular disease, or immunodeficiency state.
* BMI (kg/m\^2) values \< 19 and \> 34.
* Blood pressure readings ≥ 140 systolic and/or ≥ 90 diastolic.
* Diabetes (previously diagnosed or with hemoglobin A1c level equal to or greater than 6.4%).
* Asthma or a history of asthma.
* Bleeding/clotting disorders.
2. Individuals with a cardiovascular disease risk score greater than 10% using the ACC/AHA ASCVD risk calculator. (Based on the 10-year risk of heart disease or stroke using the Atherosclerotic Cardiovascular Disease algorithm published in 2013 American College of Cardiology/American Heart Association Guideline on the Assessment of Cardiovascular risk.)
3. Individuals who have unspecified illnesses, which in the judgment of the medical staff might increase the risk associated with wood smoke inhalation will be a basis for exclusion.
4. Individuals who have had recent (within 6 months) abdominal an/or eye surgery, or with any types of hernia, as well as any other contraindicators for raised intra-abdominal pressure.
5. Individuals who are currently taking systemic steroids or oral anticoagulants long term.
6. Individuals who are taking prescribed medications such as ß-blocker medications, that may impact the results of wood smoke challenge for the duration of the study. Other medications not specifically mentioned here may be reviewed by the medical staff prior to an individual's inclusion in the study. Use of other medications will be evaluated on a case-by-case basis. There is the potential that an individual's current medication use will preclude them from participating in the study at the current time, but they may be reassessed and potentially rescheduled for participation later based on the judgement of the medical staff.
7. Individuals who are allergic to:
* Chemical vapors or gases.
* Tape or electrodes on their skin.
* Or individuals with active allergies or currently experience allergy related symptoms
8. Individuals who are pregnant, attempting to become pregnant or breastfeeding.
9. Individuals who are currently smoking (including vaping, hookah and e-cigarette) or have smoking history within 1 year of study or have an equal to greater than or a 5-pack year smoking history.
10. Individuals living with a smoker who smokes inside the house.
11. Individuals who are regularly exposed to high levels of vapors, dust, gases, or fumes.
12. Individuals who do not read, speak, or understand English well enough to give informed consent.
13. Individuals that are unable to perform the exercise required for the study.
14. Individuals who are unwilling or unable to stop taking any current dietary supplements or vitamins for the duration of the study.
15. Individuals currently taking prebiotics, probiotics, or antihistamines.
16. Individuals who have experienced an acute respiratory illness within the last 6 weeks.
17. Individuals that will NOT comply with the following requirements:
* Avoid smoke and fumes for 24 hours before all visits.
* Avoid exposure to unvented household combustion sources (gas stoves, lit fireplaces, oil/kerosene heaters) for 48 hours before all visits.
* Avoid over-the-counter pain medications such as aspirin, Advil, Aleve, or NSAIDs for 48 hours before all visits.
* Avoid drinking alcohol 34 hours before all visits
* Avoid strenuous exercise for 24 hours prior to an after all visits.
* Eat a light breakfast and low-fat lunch on the exposure day.
* Refrain from eating pan fried and/or grilled foods 12 hours prior to the exposure days.
* Refrain from consuming caffeine for 12 hours prior to all study visits.
* Refrain from consuming food 2 hours prior to the consenting and follow up sessions, as this may interfere with induced sputum collection.
* Wear a N95 mask during all visits to the HSF. A mask will be provided to participants upon check-in.

Contacts and Locations

Principal Investigator

James Samet, PhD

PRINCIPAL_INVESTIGATOR

Environmental Protection Agency (EPA)

Study Locations (Sites)

U.S. Environmental Protection Agency Human Studies Facility

Chapel Hill, North Carolina, 27514

United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

James Samet, PhD, PRINCIPAL_INVESTIGATOR, Environmental Protection Agency (EPA)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-25

Study Completion Date2027-12

Study Record Updates

Study Start Date2021-05-25

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Healthy subjects
Wood smoke
Respiratory effects
Cardiovascular effects
Young

Additional Relevant MeSH Terms

Healthy