Treatment for Inflammation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Center for Environmental Medicine, Asthma and Lung Biology at UNC Chapel Hill, Chapel Hill, NC
Inflammation+1 More
Eligibility
18 - 65
All Sexes
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Study Summary

Woodsmoke Particulate + Hypertonic Saline

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Eligible Conditions

  • Inflammation
  • Airway Inflammation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 4 secondary outcomes in patients with Inflammation. Measurement will happen over the course of (4 hours post WSP - pre WSP [Hypertonic Saline]) vs (4 hours post WSP - pre WSP [no treatment]) and (24 hours post WSP - pre WSP [Hypertonic Saline]) vs (24 hours post WSP - pre WSP [no treatment]).

Hour 24
Change in Sputum % Neutrophils with WSP at 24 hours
Hour 4
Change in Sputum % Neutrophils with WSP Exposure
Hour 24
Change in Neutrophils/mg with WSP at 4 and 24 hours
Hour 24
Change in Neutrophils/mg with WSP at 6 and 24 hours
immediately following wood smoke exposure and treatment with hypertonic saline (or no treatment)
Mucociliary Clearance (MCC) Associated with Inhaled Wood Smoke Exposure as Affected by Hypertonic Saline

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

5% Hypertonic Saline
1 of 2
No Treatment
1 of 2
Active Control

This trial requires 14 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

5% Hypertonic Saline
Device
Subjects will inhale 5% hypertonic saline
No TreatmentNo inhaled treatment

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: (24 hours post wsp - pre wsp [hypertonic saline]) vs (24 hours post wsp - pre wsp [no treatment])
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly (24 hours post wsp - pre wsp [hypertonic saline]) vs (24 hours post wsp - pre wsp [no treatment]) for reporting.

Closest Location

Center for Environmental Medicine, Asthma and Lung Biology at UNC Chapel Hill - Chapel Hill, NC

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 18-45 years, inclusive, of both genders
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.
Ability to provide an induced sputum sample.
You are a female and you have not had a hysterectomy with oophorectomy. show original
You have a saturation of at least 93% with oxygen. show original
Subjects 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). show original
Vaccination against Coronavirus disease (COVID-19) is required. show original

Patient Q&A Section

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Other questions from users

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Inflammation by sharing your contact details with the study coordinator.