Trial Outcomes & Findings for Woodsmoke Particulate + Hypertonic Saline (NCT NCT03851406)

NCT ID: NCT03851406

Last Updated: 2025-08-08

Results Overview

Change in sputum percent neutrophils from baseline to 4 hours post WSP exposure

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: Baseline, 4 hours post WSP exposure
• Results posted on: 2025-08-08

Participant Flow

Participant milestones

Measure	5% Hypertonic Saline, Then No Inhaled Treatment Participants received 5% Hypertonic Saline following WSP exposure. After a 2-week washout period, participants received no treatment following wood smoke particles (WSP) exposure. 5% Hypertonic Saline: 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 treatment: No inhaled treatment will be provided immediately following exit from the wood smoke chamber.	No Inhaled Treatment, Then 5% Hypertonic Saline Participants received no inhaled treatment following WSP exposure. After a 2-week washout period, participants received 5% Hypertonic Saline following WSP exposure. 5% Hypertonic Saline: 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 treatment: No inhaled treatment will be provided immediately following exit from the wood smoke chamber.
First Intervention STARTED	4	5
First Intervention Received Intervention	4	3
First Intervention Received no Intervention	0	2
First Intervention COMPLETED	4	3
First Intervention NOT COMPLETED	0	2
Washout (2 Weeks) STARTED	4	3
Washout (2 Weeks) COMPLETED	4	2
Washout (2 Weeks) NOT COMPLETED	0	1
Second Intervention STARTED	3	2
Second Intervention COMPLETED	3	2
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Woodsmoke Particulate + Hypertonic Saline

Baseline characteristics by cohort

Measure	5% Hypertonic Saline, Then No Inhaled Treatment n=4 Participants Participants will receive 5% Hypertonic Saline following WSP exposure. After a 2-week washout period, participants will receive no treatment following WSP exposure. 5% Hypertonic Saline: 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 treatment: No inhaled treatment will be provided immediately following exit from the wood smoke chamber.	No Inhaled Treatment, Then 5% Hypertonic Saline n=3 Participants Participants will receive no inhaled treatment following WSP exposure. After a 2-week washout period, participants will receive 5% Hypertonic Saline following WSP exposure. 5% Hypertonic Saline: 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 treatment: No inhaled treatment will be provided immediately following exit from the wood smoke chamber.	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 4 hours post WSP exposure

Population: An attempt was made to analyze samples for all participants; although some samples had an inadequate cell differential slide. Data are reported for all samples that yielded data for each endpoint and at each time.

Change in sputum percent neutrophils from baseline to 4 hours post WSP exposure

Outcome measures

Measure	5% Hypertonic Saline n=5 Participants Participants received 5% Hypertonic Saline following WSP exposure. 5% Hypertonic Saline: 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 Inhaled Treatment n=5 Participants Participants received no inhaled treatment following WSP exposure. No treatment: No inhaled treatment will be provided immediately following exit from the wood smoke chamber.
Change From Baseline to 4 Hours in Sputum Percent Neutrophils	-0.04 percent neutrophils Interval -12.0 to 12.0	-0.5 percent neutrophils Interval -3.7 to 1.4

PRIMARY outcome

Timeframe: Baseline, 24 hours post WSP exposure

Population: An attempt was made to analyze samples for all participants; although some samples had an inadequate cell differential slide. Data are reported for all samples that yielded data for each endpoint and at each time.

Change in sputum percent neutrophils from baseline to 24 hours post WSP exposure

Outcome measures

Measure	5% Hypertonic Saline n=6 Participants Participants received 5% Hypertonic Saline following WSP exposure. 5% Hypertonic Saline: 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 Inhaled Treatment n=5 Participants Participants received no inhaled treatment following WSP exposure. No treatment: No inhaled treatment will be provided immediately following exit from the wood smoke chamber.
Change From Baseline to 24 Hours in Sputum Percent Neutrophils	17 percent neutrophils Interval -0.25 to 30.0	29 percent neutrophils Interval 1.5 to 36.0

SECONDARY outcome

Timeframe: Baseline, 4 and 24 hours post WSP exposure

Population: An attempt was made to analyze samples for all participants; although some samples had an inadequate cell differential slide. Data are reported for all samples that yielded data for each endpoint and at each time.

Neutrophil numbers/mg compared at 4 and 24 hours post WSP exposure with respect to Baseline.

Outcome measures

Measure	5% Hypertonic Saline n=6 Participants Participants received 5% Hypertonic Saline following WSP exposure. 5% Hypertonic Saline: 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 Inhaled Treatment n=5 Participants Participants received no inhaled treatment following WSP exposure. No treatment: No inhaled treatment will be provided immediately following exit from the wood smoke chamber.
Change in Number of Sputum Neutrophils 4 hours post WSP exposure	0.40 Neutrophils/mg Interval -6.9 to 203.0	19 Neutrophils/mg Interval -41.0 to 70.0
Change in Number of Sputum Neutrophils 24 hours post WSP exposure	9.5 Neutrophils/mg Interval -261.0 to 174.0	79 Neutrophils/mg Interval 16.0 to 148.0

SECONDARY outcome

Timeframe: Baseline, 4 and 24 hours post WSP exposure

Population: An attempt was made to analyze samples for all participants; although some samples had an inadequate cell differential slide. Data are reported for all samples that yielded data for each endpoint and at each time.

Eosinophil numbers/mg compared at 4 and 24 hours post WSP exposure with respect to Baseline.

Outcome measures

Measure	5% Hypertonic Saline n=6 Participants Participants received 5% Hypertonic Saline following WSP exposure. 5% Hypertonic Saline: 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 Inhaled Treatment n=5 Participants Participants received no inhaled treatment following WSP exposure. No treatment: No inhaled treatment will be provided immediately following exit from the wood smoke chamber.
Change in Number of Sputum Eosinophils 4 hours post WSP exposure	0 Eosinophils/mg Interval -1.3 to 28.0	0 Eosinophils/mg Interval -0.32 to 0.42
Change in Number of Sputum Eosinophils 24 hours post WSP exposure	-0.10 Eosinophils/mg Interval -1.4 to 0.74	0.45 Eosinophils/mg Interval -0.18 to 3.3

SECONDARY outcome

Timeframe: Baseline, 4 and 24 hours post WSP exposure

Population: An attempt was made to analyze samples for all participants; although some samples had an inadequate cell differential slide. Data are reported for all samples that yielded data for each endpoint and at each time.

Percent eosinophils compared at 4 and 24 hours post WSP exposure with respect to Baseline.

Outcome measures

Measure	5% Hypertonic Saline n=6 Participants Participants received 5% Hypertonic Saline following WSP exposure. 5% Hypertonic Saline: 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 Inhaled Treatment n=5 Participants Participants received no inhaled treatment following WSP exposure. No treatment: No inhaled treatment will be provided immediately following exit from the wood smoke chamber.
Change in Percent Sputum Eosinophils 4 hours post WSP exposure	0.33 percent eosinophils Interval 0.0 to 0.89	0.00 percent eosinophils Interval -0.24 to 0.11
Change in Percent Sputum Eosinophils 24 hours post WSP exposure	0.00 percent eosinophils Interval -0.23 to 0.12	0.00 percent eosinophils Interval -0.11 to 13.0

SECONDARY outcome

Timeframe: Baseline, 4 and 24 hours post WSP exposure

Population: An attempt was made to analyze samples for all participants; although some samples had an insufficient sample quantity. Data are reported for all samples that yielded data for each endpoint and at each time.

Interleukin-1β via the Mesoscale platform (pg/mL) compared at 4 and 24 hours post-WSP exposure with respect to Baseline.

Outcome measures

Measure	5% Hypertonic Saline n=6 Participants Participants received 5% Hypertonic Saline following WSP exposure. 5% Hypertonic Saline: 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 Inhaled Treatment n=5 Participants Participants received no inhaled treatment following WSP exposure. No treatment: No inhaled treatment will be provided immediately following exit from the wood smoke chamber.
Change in Interleukin-1b 4 hours post WSP exposure	0.95 pg/mL Interval -7.7 to 3.8	-2.5 pg/mL Interval -5.5 to -0.23
Change in Interleukin-1b 24 hours post WSP exposure	0.41 pg/mL Interval -6.3 to 7.8	-0.58 pg/mL Interval -7.8 to 1.6

SECONDARY outcome

Timeframe: Baseline, 4 and 24 hours post WSP exposure

Population: An attempt was made to analyze samples for all participants; although some samples had an insufficient sample quantity. Data are reported for all samples that yielded data for each endpoint and at each time.

Interleukin-6 via Mesoscale platform (pg/mL) compared at 4 and 24 hours post WSP exposure with respect to Baseline.

Outcome measures

Measure	5% Hypertonic Saline n=6 Participants Participants received 5% Hypertonic Saline following WSP exposure. 5% Hypertonic Saline: 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 Inhaled Treatment n=5 Participants Participants received no inhaled treatment following WSP exposure. No treatment: No inhaled treatment will be provided immediately following exit from the wood smoke chamber.
Change in Interleukin-6 4 hours post WSP exposure	0.94 pg/mL Interval -2.1 to 4.4	-1.2 pg/mL Interval -3.4 to 1.4
Change in Interleukin-6 24 hours post WSP exposure	0.73 pg/mL Interval -1.2 to 35.0	-1.9 pg/mL Interval -2.2 to 5.7

SECONDARY outcome

Timeframe: Baseline, 4 and 24 hours post WSP exposure

Population: An attempt was made to analyze samples for all participants; although some samples had an insufficient sample quantity. Data are reported for all samples that yielded data for each endpoint and at each time.

Interleukin-8 via Mesoscale platform (pg/mL) compared at 4 and 24 hours post WSP exposure with respect to Baseline.

Outcome measures

Measure	5% Hypertonic Saline n=6 Participants Participants received 5% Hypertonic Saline following WSP exposure. 5% Hypertonic Saline: 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 Inhaled Treatment n=5 Participants Participants received no inhaled treatment following WSP exposure. No treatment: No inhaled treatment will be provided immediately following exit from the wood smoke chamber.
Change in Interleukin-8 4 hours post WSP exposure	-37 pg/mL Interval -232.0 to 1027.0	-138 pg/mL Interval -209.0 to 95.0
Change in Interleukin-8 24 hours post WSP exposure	65 pg/mL Interval -55.0 to 177.0	82 pg/mL Interval -322.0 to 437.0

SECONDARY outcome

Timeframe: Baseline, 4 and 24 hours post WSP exposure

Population: An attempt was made to analyze samples for all participants; although some samples had an insufficient sample quantity. Data are reported for all samples that yielded data for each endpoint and at each time.

Tumor Necrosis Factor Alpha via Mesoscale platform (pg/mL) compared at 4 and 24 hours post WSP exposure with respect to Baseline.

Outcome measures

Measure	5% Hypertonic Saline n=6 Participants Participants received 5% Hypertonic Saline following WSP exposure. 5% Hypertonic Saline: 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 Inhaled Treatment n=5 Participants Participants received no inhaled treatment following WSP exposure. No treatment: No inhaled treatment will be provided immediately following exit from the wood smoke chamber.
Change in Tumor Necrosis Factor Alpha 4 hours post WSP exposure	0.00 pg/mL Interval -3.6 to 0.81	-0.35 pg/mL Interval -0.39 to -0.05
Change in Tumor Necrosis Factor Alpha 24 hours post WSP exposure	0.05 pg/mL Interval -0.1 to 11.0	0.22 pg/mL Interval -0.38 to 0.37

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 hours post WSP exposure]

4 hours post WSP exposure, the MCC is done. A whole lung region of interest (ROI) bordering the right lung is used to estimate (by computer analysis) whole lung retention of inhaled radiolabeled particles. Labeled particle counts are measured over a 2 hour period to determine the fraction of initial particle counts remaining. From this data, the investigators will determine the percentage of labeled particles cleared from the lung during the 2 hour observation period.

Outcome measures

Outcome data not reported

Adverse Events

5% Hypertonic Saline

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

No Inhaled Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	5% Hypertonic Saline n=6 participants at risk Participants received 5% Hypertonic Saline following WSP exposure. 5% Hypertonic Saline: 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 Inhaled Treatment n=6 participants at risk Participants received no inhaled treatment following WSP exposure. No treatment: No inhaled treatment will be provided immediately following exit from the wood smoke chamber.
Respiratory, thoracic and mediastinal disorders Wheezing	16.7% 1/6 • Number of events 1 • 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.	0.00% 0/6 • 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.
Respiratory, thoracic and mediastinal disorders Nose bleed	0.00% 0/6 • 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.	16.7% 1/6 • Number of events 1 • 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.

Additional Information

Terry Noah, MD

University of North Carolina at Chapel Hill

Phone: 919-966-1055

Email: terry_noah@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place