CompletedNot Applicable

Woodsmoke Particulate + Hypertonic Saline

United States9 participantsStarted 2019-08-01

Plain-language 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 investigator has 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 a single treatment of inhaled hypertonic saline (HS) can diminish this PM-induced airway inflammation by rapidly clearing the WSP inhaled particles from airway surfaces. The exposure will be 500 ug/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.

Who can participate

Age range18 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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) ratio of \>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 #15-1775). * Proof of vaccination to SARS-CoV-2 based on public health guidelines at time of inclusion 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 oximetr…

What they're measuring

Change From Baseline to 4 Hours in Sputum Percent Neutrophils

Timeframe: Baseline, 4 hours post WSP exposure

Change From Baseline to 24 Hours in Sputum Percent Neutrophils

Timeframe: Baseline, 24 hours post WSP exposure

Trial details

NCT IDNCT03851406

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-12

Results submitted2025-07-23