Overview

Woodsmoke Particulate + Prednisone

Status:
Recruiting
Trial end date:
2022-02-01
Target enrollment:
0
Participant gender:
All
Summary
Deployment of military personnel has been associated with increased respiratory illness likely due, in part, to inhalation of unusual particulate matter (PM), such as from burn pits. Inflammation is a key initial response to inhaled particulates. The researchers have developed a protocol using inhaled wood smoke particles (WSP) as a way to study PM-induced airway inflammation. Exposure to wood smoke particles causes symptoms, even in healthy people, such as eye irritation, cough, shortness of breath, and increased mucous production. The purpose of this research study is to see if an oral steroid treatment can reduce the airway inflammation caused by the inhaled WSP. The exposure will be 500 µg/m³ of WSP for 2 hours, with intermittent exercise on a bicycle and rest. The wood is burned in a typical wood stove and piped into the chamber.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
United States Department of Defense
Treatments:
Prednisone
Criteria
Inclusion Criteria:

- Age 18-45 years, inclusive, of both genders

- Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy

- No history of episodic wheezing, chest tightness, or shortness of breath consistent
with asthma, or physician-diagnosed asthma.

- Forced expiratory volume at one second (FEV1) of at least 80% of predicted and FEV1/
forced vital capacity (FVC) ≥0.70.

- Oxygen saturation of ≥93%

- Ability to provide an induced sputum sample.

- Subject must demonstrate a ≥10% increase in sputum %PMNs 6 hours following inhaled WSP
exposure, when compared to baseline sputum (to be completed in a separate protocol
IRB# 15-1775).

Exclusion Criteria:

Clinical contraindications:

- 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.

- 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 4 weeks of challenge.

- Abnormal physical findings at the baseline visit, including but not limited to
abnormalities on auscultation, temperature of 37.8° C, Systolic BP > 150mm Hg or < 85
mm Hg; or Diastolic BP > 90 mm Hg or < 50 mm Hg, or pulse oximetry saturation reading
less than 93%.

- Physician diagnosis of asthma

- If there is a history of allergic rhinitis, subjects must be asymptomatic of allergic
rhinitis at the time of study enrollment.

- 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.

- Medications which may impact the results of the WSP exposure, interfere with any other
medications potentially used in the study (to include steroids, beta antagonists,
non-steroidal anti-inflammatory agents)

- Cigarette smoking > 1 pack per month

- Unwillingness to use reliable contraception if sexually active (IUD, birth control
pills/patch, condoms).

- Use of immunosuppressive or anticoagulant medications including routine use of NSAIDS.
Oral contraceptives are acceptable, as are antidepressants and other medications may
be permitted if, in the opinion of the investigator, the medication will not interfere
with the study procedures or compromise safety and if the dosage has been stable for 1
month.

- Orthopedic injuries or impediments that would preclude bicycle or treadmill exercise.

- Inability to avoid NSAIDS, Multivitamins, Vitamin C or E or herbal supplements.

- Allergy/sensitivity to study drugs or their formulations

- Pregnant/lactating women and children (< 18 years as this is age of majority in North
Carolina) will also be excluded since the risks associated with WSP exposure to the
fetus or child, respectively, are unknown and cannot be justified for this
non-therapeutic protocol. Individuals over 45 years of age will not be included due to
the increased possibility of co-morbidities and need for prohibited medications.

- Inability or unwillingness of a participant to give written informed consent