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Trial record 1 of 1 for:    03851406
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Woodsmoke Particulate + Hypertonic Saline (Smokeysal)

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ClinicalTrials.gov Identifier: NCT03851406
Recruitment Status : Enrolling by invitation
First Posted : February 22, 2019
Last Update Posted : August 2, 2022
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief 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.

Condition or disease Intervention/treatment Phase
Airway Inflammation Device: 5% Hypertonic Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: To determine the efficacy of nebulized 5% hypertonic saline (HS) (v. no treatment) in mitigating wood smoke particulate (WSP)-induced neutrophilic airway inflammation, assessed via sputum %polymorphonuclear leukocytes (PMNs), in healthy adults 4 hours post WSP exposure.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Randomized Cross-over Study of Hypertonic Saline on Airway Inflammatory Response to Inhaled Wood Smoke
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024


Arm Intervention/treatment
Active Comparator: 5% Hypertonic Saline
Subjects will inhale 5% hypertonic saline
Device: 5% Hypertonic Saline
Subjects will inhale 15 mL of 5% HS for 15 minutes delivered by Pari neb with a coached cough maneuver

No Intervention: No Treatment
No inhaled treatment



Primary Outcome Measures :
  1. Change in Sputum % Neutrophils with WSP Exposure [ Time Frame: (4 hours post WSP - pre WSP [Hypertonic Saline]) vs (4 hours post WSP - pre WSP [no treatment]) ]

Secondary Outcome Measures :
  1. Change in Sputum % Neutrophils with WSP at 24 hours [ Time Frame: (24 hours post WSP - pre WSP [Hypertonic Saline]) vs (24 hours post WSP - pre WSP [no treatment]) ]
  2. Change in Neutrophils/mg with WSP at 4 and 24 hours [ Time Frame: (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]) ]
  3. Mucociliary Clearance (MCC) Associated with Inhaled Wood Smoke Exposure as Affected by Hypertonic Saline [ Time Frame: immediately following wood smoke exposure and treatment with hypertonic saline (or no treatment) ]
    Immediately after exiting the wood smoke chamber, participants will either receive hypertonic saline treatment or no treatment while 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 percentage of labeled particles cleared from the lung during the 2 hour observation period will be determined and compare hypertonic saline treatment vs no treatment.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-45 years, inclusive, of both genders
  • 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.
  • forced expiratory volume at one second (FEV1) of at least 80% of predicted and FEV1/forced vital capacity (FVC) ratio of >0.70.
  • Oxygen saturation of >93%
  • Ability to provide an induced sputum sample.
  • Subject 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).
  • Proof of vaccination to Covid based on public health guidelines at time of inclusion

Exclusion Criteria:

  • Clinical contraindications:
  • Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections/immunodeficiency.
  • Viral upper respiratory tract infection within 4 weeks of challenge.
  • Any acute infection requiring antibiotics within 4 weeks of exposure or fever of unknown origin within 4 weeks of challenge.
  • Abnormal physical findings at the baseline visit, including but not limited to abnormalities on auscultation, temperature of 37.8° C, Systolic BP > 150mm Hg or < 85 mm Hg; or Diastolic BP > 90 mm Hg or < 50 mm Hg, or pulse oximetry saturation reading less than 93%.
  • Physician diagnosis of asthma
  • If there is a history of allergic rhinitis, subjects must be asymptomatic of allergic rhinitis at the time of study enrollment.
  • Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
  • Medications which may impact the results of the WSP exposure, interfere with any other medications potentially used in the study (to include steroids, beta antagonists, non-steroidal anti-inflammatory agents)
  • Cigarette smoking > 1 pack per month
  • Unwillingness to use reliable contraception if sexually active (IUD, birth control pills/patch, condoms).
  • Use of immunosuppressive or anticoagulant medications including routine use of NSAIDS. Oral contraceptives are acceptable, as are antidepressants and other medications may be permitted if, in the opinion of the investigator, the medication will not interfere with the study procedures or compromise safety and if the dosage has been stable for 1 month.
  • Orthopedic injuries or impediments that would preclude bicycle or treadmill exercise.
  • Inability to avoid NSAIDS, Multivitamins, Vitamin C or E or herbal supplements.
  • Allergy/sensitivity to study drugs or their formulations
  • Positive Covid test in the past 90 days.
  • Pregnant/lactating women and children (< 18 years as this is age of majority in North Carolina) will also be excluded since the risks associated with WSP exposure to the fetus or child, respectively, are unknown and cannot be justified for this non-therapeutic protocol. Individuals over 45 years of age will not be included due to the increased possibility of co-morbidities and need for prohibited medications.
  • Inability or unwillingness of a participant to give written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03851406


Locations
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United States, North Carolina
Center for Environmental Medicine, Asthma and Lung Biology at UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
United States Department of Defense
Investigators
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Principal Investigator: Terry Noah, M.D UNC Chapel Hill
Publications:
Jones B, and Kenward, M.G. . Design and analysis of cross-over trials. Third ed: CRC Press; 2015.

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03851406    
Other Study ID Numbers: 18-1895
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes