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Woodsmoke Particulate + Hypertonic Saline
NA trial testing 5% Hypertonic Saline in Airway Inflammation in 9 participants. Completed in 12 September 2024.
| Lead sponsor | University of North Carolina, Chapel Hill |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 1 August 2019 |
| Primary completion | 12 September 2024 |
| Estimated completion | 12 September 2024 |
| Sites | 1 location across United States |
University of North Carolina, Chapel Hill
Adults 18 to 45, any sex, with Airway Inflammation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in sputum percent neutrophils from baseline to 4 hours post WSP exposure
| Group | Value | 95% CI |
|---|---|---|
| 5% Hypertonic Saline | -0.04 | -12 – 12 |
| No Inhaled Treatment | -0.5 | -3.7 – 1.4 |
Change in sputum percent neutrophils from baseline to 24 hours post WSP exposure
| Group | Value | 95% CI |
|---|---|---|
| 5% Hypertonic Saline | 17 | -0.25 – 30 |
| No Inhaled Treatment | 29 | 1.5 – 36 |
Neutrophil numbers/mg compared at 4 and 24 hours post WSP exposure with respect to Baseline.
| Group | Value | 95% CI |
|---|---|---|
| 5% Hypertonic Saline | 0.40 | -6.9 – 203 |
| No Inhaled Treatment | 19 | -41 – 70 |
| Group | Value | 95% CI |
|---|---|---|
| 5% Hypertonic Saline | 9.5 | -261 – 174 |
| No Inhaled Treatment | 79 | 16 – 148 |
Eosinophil numbers/mg compared at 4 and 24 hours post WSP exposure with respect to Baseline.
| Group | Value | 95% CI |
|---|---|---|
| 5% Hypertonic Saline | 0 | -1.3 – 28 |
| No Inhaled Treatment | 0 | -0.32 – 0.42 |
| Group | Value | 95% CI |
|---|---|---|
| 5% Hypertonic Saline | -0.10 | -1.4 – 0.74 |
| No Inhaled Treatment | 0.45 | -0.18 – 3.3 |
Percent eosinophils compared at 4 and 24 hours post WSP exposure with respect to Baseline.
| Group | Value | 95% CI |
|---|---|---|
| 5% Hypertonic Saline | 0.33 | 0.00 – 0.89 |
| No Inhaled Treatment | 0.00 | -0.24 – 0.11 |
| Group | Value | 95% CI |
|---|---|---|
| 5% Hypertonic Saline | 0.00 | -0.23 – 0.12 |
| No Inhaled Treatment | 0.00 | -0.11 – 13.00 |
Interleukin-1β via the Mesoscale platform (pg/mL) compared at 4 and 24 hours post-WSP exposure with respect to Baseline.
| Group | Value | 95% CI |
|---|---|---|
| 5% Hypertonic Saline | 0.95 | -7.7 – 3.8 |
| No Inhaled Treatment | -2.5 | -5.5 – -0.23 |
| Group | Value | 95% CI |
|---|---|---|
| 5% Hypertonic Saline | 0.41 | -6.3 – 7.8 |
| No Inhaled Treatment | -0.58 | -7.8 – 1.6 |
Interleukin-6 via Mesoscale platform (pg/mL) compared at 4 and 24 hours post WSP exposure with respect to Baseline.
| Group | Value | 95% CI |
|---|---|---|
| 5% Hypertonic Saline | 0.94 | -2.1 – 4.4 |
| No Inhaled Treatment | -1.2 | -3.4 – 1.4 |
| Group | Value | 95% CI |
|---|---|---|
| 5% Hypertonic Saline | 0.73 | -1.2 – 35 |
| No Inhaled Treatment | -1.9 | -2.2 – 5.7 |
Interleukin-8 via Mesoscale platform (pg/mL) compared at 4 and 24 hours post WSP exposure with respect to Baseline.
| Group | Value | 95% CI |
|---|---|---|
| 5% Hypertonic Saline | -37 | -232 – 1027 |
| No Inhaled Treatment | -138 | -209 – 95 |
| Group | Value | 95% CI |
|---|---|---|
| 5% Hypertonic Saline | 65 | -55 – 177 |
| No Inhaled Treatment | 82 | -322 – 437 |
Tumor Necrosis Factor Alpha via Mesoscale platform (pg/mL) compared at 4 and 24 hours post WSP exposure with respect to Baseline.
| Group | Value | 95% CI |
|---|---|---|
| 5% Hypertonic Saline | 0.00 | -3.60 – 0.81 |
| No Inhaled Treatment | -0.35 | -0.39 – -0.05 |
| Group | Value | 95% CI |
|---|---|---|
| 5% Hypertonic Saline | 0.05 | -0.10 – 11.00 |
| No Inhaled Treatment | 0.22 | -0.38 – 0.37 |
Time frame: From the time of signing informed consent through final follow-up visit which occurred one week after the final wood smoke exposure, up to 3 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | 5% Hypertonic Saline | No Inhaled Treatment |
|---|---|---|---|
| Wheezing | Respiratory, thoracic and mediastinal disorders | — | — |
| Nose bleed | Respiratory, thoracic and mediastinal disorders | — | — |
Data from ClinicalTrials.gov NCT03851406 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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