CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9 enrolled
Drug / intervention
5% Hypertonic Saline +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03851406
NCT03851406N/ACompleted

Phase I/II Randomized Cross-over Study of Hypertonic Saline on Airway Inflammatory Response to Inhaled Wood Smoke

University of North Carolina, Chapel Hill·interventional·Posted Feb 22, 2019·Updated Aug 8, 2025

In Brief

A clinical study evaluating 5% Hypertonic Saline and No treatment for Airway Inflammation. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 22, 2019
Enrollment StartAug 1, 2019
Primary CompletionSep 12, 2024
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 7.4 years ago

Interventions

5% Hypertonic Salinedevice

Immediately following exit from the wood smoke chamber, participants will inhale 15 mL of 5% Hypertonic Saline for 15 minutes delivered by Pari neb with a coached cough maneuver.

No treatmentother

No inhaled treatment will be provided immediately following exit from the wood smoke chamber.