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Woodsmoke Particulate + Prednisone (Smokisone)

Primary Purpose

Airway Inflammation

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
60 mg Prednisone
Placebo
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Airway Inflammation

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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) ≥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

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

Sites / Locations

  • Center for Environmental Medicine, Asthma and Lung Biology at UNC Chapel HillRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Prednisone, then Placebo

Placebo, then Prednisone

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline to 4 Hours in Sputum Percent Neutrophils
Change in sputum percent neutrophils from baseline to 4 hours post WSP exposure
Change From Baseline to 24 Hours in Sputum Percent Neutrophils
Change in sputum percent neutrophils from baseline to 24 hours post WSP exposure

Secondary Outcome Measures

Change in Number of Sputum Neutrophils
Neutrophil numbers/mg measured at 4 and 24 hours post WSP exposure
Change in Number of Sputum Eosinophils
Eosinophil numbers/mg measured at 4 and 24 hours post WSP exposure
Change in Percent Sputum Eosinophils
Percent eosinophil measured at 4 and 24 hours post WSP exposure
Change in IL-1b
IL-1b via Mesoscale platform (pg/mL) at 4 and 24 hours post WSP exposure
Change in IL-6
IL-6 via Mesoscale platform (pg/mL) at 4 and 24 hours post WSP exposure
Change in IL-8
IL-8 via Mesoscale platform (pg/mL) at 4 and 24 hours post WSP exposure
Change in TNFa
TNFa via Mesoscale platform (pg/mL) at 4 and 24 hours post WSP exposure

Full Information

First Posted
March 1, 2019
Last Updated
August 25, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT03861390
Brief Title
Woodsmoke Particulate + Prednisone
Acronym
Smokisone
Official Title
Phase I/II Randomized, Double-blind, Placebo-controlled Cross-over Study of Prednisone on Airway Inflammatory Response to Inhaled Wood Smoke.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2019 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 researchers have 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 an oral steroid treatment can reduce the airway inflammation caused by the inhaled WSP. The exposure will be 500 µg/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.
Detailed Description
Military deployment is associated with exposure to novel particulate matter (PM), such as from burn pits, aeroallergens, and increased cigarette consumption. War fighters exposed to these inhalational exposures exhibit immediate and chronic respiratory morbidity. For example, military service personnel surveyed in both the Republic of Korea (ROK) and Kabul, Afghanistan reported a general increase in respiratory morbidity, including asthma and chronic bronchitis, associated with their deployment. Air contaminants in the ROK were characterized by elevated levels of both PM 0.5-2.5 and PM 2.5-10. Similarly, exposures in Kabul were characterized by multiple airborne PM exposures, including those from burn pits. Burn pit PM includes metals, bioaerosols, organic by-products, and biomass combustion particles. These findings indicate that inhaled PM is a likely cause of respiratory morbidity in the field. Inflammation is a key initial response to inhaled particulates. Wood smoke particles (WSP) serve as a model agent to study PM-induced bronchitis. WSP inhalation generates reactive oxidant (and nitrosative) species which cause local injury of airway epithelial cells and release of damage-associated molecular patterns (DAMPs) that activate toll-like receptors (TLR) and Interleukin (IL)-1-mediated innate immune responses by resident airway macrophages. Contamination of PM with bioaerosols, which contain lipopolysaccharide (LPS), also activates innate immune responses through toll-like receptor 4 (TLR4) activation of resident airway macrophages. These complementary processes result in recruitment of neutrophils (PMN), which mediate luminal airway inflammation with release of toxic mediators such as neutrophil elastase and myeloperoxidase that promote acute and chronic bronchitis. Therefore, mitigation of PM-induced airway neutrophilic inflammation should be a key focus in order to reduce the respiratory morbidity of military personnel. The researchers have studied a number of pro-inflammatory inhaled agents, such as nebulized LPS, ozone (O3), and WSP, as models of acute neutrophilic bronchitis against which to test a number of therapeutic agents. To this effect, the researchers have reported that inhaled fluticasone inhibits O3-induced and LPS-induced neutrophilic inflammation, and that parenteral anakinra and oral gamma-tocopherol inhibit neutrophilic responses to inhaled LPS. In this study, the researchers will evaluate the efficacy of oral prednisone, a readily available anti-inflammatory medication commonly used in airway inflammatory diseases, in mitigating WSP-induced airway inflammation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Model Description
The randomization schedule will be generated by using permuted block randomization with a block size of 4 (2 prednisone, 2 placebo for the first treatment period of the protocol).
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prednisone, then Placebo
Arm Type
Active Comparator
Arm Title
Placebo, then Prednisone
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
60 mg Prednisone
Intervention Description
Immediately following exit from the wood smoke chamber, subjects will receive 60 mg of prednisone per randomization schema
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Immediately following exit from the wood smoke chamber, subjects will receive a matching placebo to the 60 mg of prednisone per randomization schema
Primary Outcome Measure Information:
Title
Change From Baseline to 4 Hours in Sputum Percent Neutrophils
Description
Change in sputum percent neutrophils from baseline to 4 hours post WSP exposure
Time Frame
Baseline, 4 hours post WSP exposure
Title
Change From Baseline to 24 Hours in Sputum Percent Neutrophils
Description
Change in sputum percent neutrophils from baseline to 24 hours post WSP exposure
Time Frame
Baseline, 24 hours post WSP exposure
Secondary Outcome Measure Information:
Title
Change in Number of Sputum Neutrophils
Description
Neutrophil numbers/mg measured at 4 and 24 hours post WSP exposure
Time Frame
up to 24 hours
Title
Change in Number of Sputum Eosinophils
Description
Eosinophil numbers/mg measured at 4 and 24 hours post WSP exposure
Time Frame
up to 24 hours
Title
Change in Percent Sputum Eosinophils
Description
Percent eosinophil measured at 4 and 24 hours post WSP exposure
Time Frame
up to 24 hours
Title
Change in IL-1b
Description
IL-1b via Mesoscale platform (pg/mL) at 4 and 24 hours post WSP exposure
Time Frame
up to 24 hours
Title
Change in IL-6
Description
IL-6 via Mesoscale platform (pg/mL) at 4 and 24 hours post WSP exposure
Time Frame
up to 24 hours
Title
Change in IL-8
Description
IL-8 via Mesoscale platform (pg/mL) at 4 and 24 hours post WSP exposure
Time Frame
up to 24 hours
Title
Change in TNFa
Description
TNFa via Mesoscale platform (pg/mL) at 4 and 24 hours post WSP exposure
Time Frame
up to 24 hours
Other Pre-specified Outcome Measures:
Title
Mucociliary Clearance (MCC)
Description
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.
Time Frame
4 hours post WSP exposure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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) ≥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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carole Robinette, MS
Phone
919-966-5683
Email
carole_robinette@med.unc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Chris Brooks, BS
Phone
919-843-6598
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Noah, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Environmental Medicine, Asthma and Lung Biology at UNC Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carole Robinette
Phone
919-966-5638
Email
carole_robinette@med.unc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
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Woodsmoke Particulate + Prednisone

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