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Inhaled Hypertonic Saline for Bronchitis (Smokeysal Trial)

N/A

Waitlist Available

Led By Terry Noah, M.D

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 hours

Awards & highlights

Smokeysal Trial Summary

This trial will study whether a single treatment of inhaled hypertonic saline can reduce wood smoke particle-induced airway inflammation.

Who is the study for?

Healthy individuals aged 18-45, both genders, non-pregnant with normal oxygen levels and lung function. Must have received COVID vaccination as per guidelines and be able to produce a sputum sample. Excludes those with recent respiratory infections, abnormal physical findings, significant medical conditions or medication use that could affect the study.Check my eligibility

What is being tested?

The trial is testing if inhaling hypertonic saline can reduce airway inflammation caused by wood smoke particles (WSP). Participants will be exposed to WSP for two hours while doing intermittent exercise and rest to see if the saline helps clear the particles from their airways.See study design

What are the potential side effects?

Inhaling wood smoke particles may cause eye irritation, coughing, shortness of breath, and increased mucus production. The side effects of hypertonic saline are not detailed but typically include a salty taste in mouth or throat irritation.

Smokeysal Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant or have had a hysterectomy with oophorectomy.

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I have never had asthma or symptoms like wheezing or chest tightness.

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I am between 18 and 45 years old.

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I can provide a sputum sample when asked.

Smokeysal Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change From Baseline to 24 Hours in Sputum Percent Neutrophils

Change From Baseline to 4 Hours in Sputum Percent Neutrophils

Secondary outcome measures

Change in IL-1b

Change in IL-6

Change in IL-8

+4 more

Other outcome measures

Mucociliary Clearance (MCC)

Smokeysal Trial Design

2Treatment groups

Active Control

Group I: 5% Hypertonic Saline, then No Inhaled TreatmentActive Control2 Interventions

Participants will receive 5% Hypertonic Saline following WSP exposure. After a 2-week washout period, participants will receive no treatment following WSP exposure.

Group II: No Inhaled Treatment, then 5% Hypertonic SalineActive Control2 Interventions

Participants will receive no inhaled treatment following WSP exposure. After a 2-week washout period, participants will receive 5% Hypertonic Saline following WSP exposure.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,504 Previous Clinical Trials

4,187,648 Total Patients Enrolled

4 Trials studying Bronchitis

3,106 Patients Enrolled for Bronchitis

United States Department of DefenseFED

861 Previous Clinical Trials

227,180 Total Patients Enrolled

Terry Noah, M.DPrincipal InvestigatorUNC Chapel Hill

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age criterion of this research extend beyond 25 years?

"This research is seeking individuals who have surpassed the age of consent and are yet to reach 45 years old."

Answered by AI

Does this clinical experiment currently have open slots for participants?

"According to the clinicaltrials.gov webpage, this research is not currently in search of participants. The study was initially put up on August 1st 2019 and last edited July 28th 2022; however, there are 355 other trials actively recruiting patients presently."

Answered by AI

Is there an avenue for me to partake in this experiment?

"To be eligible for enrolment, individuals must display signs of inflammation and fit within the age window between 18-45. The research team is looking to accept a total of 14 patients into this medical trial."

Answered by AI

Recent research and studies

Journal of Allergy and Clinical ImmunologyJournal

IL-1 Receptor Antagonist Reduces Endotoxin-induced Airway Inflammation in Healthy Volunteers

Hernandez, Michelle L., Katherine Mills, Martha Almond, Krista Todoric, Maria M. Aleman, Hongtao Zhang, Haibo Zhou, and David B. Peden. 2015. “IL-1 Receptor Antagonist Reduces Endotoxin-induced Airway Inflammation in Healthy Volunteers”. Journal of Allergy and Clinical Immunology. Elsevier BV. doi:10.1016/j.jaci.2014.07.039.

ChestJournal

Elevated Airway Purines in COPD

Esther, Charles R., Jr, Aili L. Lazaar, Elena Bordonali, Bahjat Qaqish, and Richard C. Boucher. 2011. “Elevated Airway Purines in COPD”. Chest. Elsevier BV. doi:10.1378/chest.10-2471.

Military MedicineJournal

Increasing Prevalence of Chronic Lung Disease in Veterans of the Wars in Iraq and Afghanistan

Pugh, Mary Jo, Carlos A. Jaramillo, Kar-wei Leung, Paola Faverio, Nicholas Fleming, Eric Mortensen, Megan E. Amuan, et al.. 2016. “Increasing Prevalence of Chronic Lung Disease in Veterans of the Wars in Iraq and Afghanistan”. Military Medicine. Oxford University Press (OUP). doi:10.7205/milmed-d-15-00035.

American Journal of Respiratory and Critical Care MedicineJournal