Phase 2 N=12 Randomized Triple-blind Treatment

Woodsmoke Particulate + Prednisone

Airway Inflammation

Bottom Line

View on ClinicalTrials.gov: NCT03861390 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2024

Primary outcome: Primary: Change From Baseline to 4 Hours in Sputum Percent Neutrophils — -2.62; 5.45 percent neutrophils — p=0.24

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 60 mg Prednisone (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to 4 Hours in Sputum Percent Neutrophils	-2.62; 5.45	0.24
PRIMARY Change From Baseline to 24 Hours in Sputum Percent Neutrophils	8.07; 22.68	0.17
SECONDARY Change in Number of Sputum Neutrophils	52.00; 36.00; -17.00; 37.00	0.70
SECONDARY Change in Number of Sputum Eosinophils	0.00; 0.00; 0.00; 0.00	0.77
SECONDARY Change in Percent Sputum Eosinophils	0.00; 0.00; 0.00; 0.00	0.96
SECONDARY Change in IL-1b	39.60; -41.80; 357.00; 128.00	0.46
SECONDARY Change in IL-6	52.78; 80.35; 37.69; 0.00	0.82
SECONDARY Change in IL-8	1416.00; 869.00; 4835.00; 627.00	0.38
SECONDARY Change in TNFa	-3.63; 0.00; 17.70; 0.00	0.49

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.

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 # 15-1775).
Proof of vaccination to COVID-19.

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 90 mm Hg or 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-19 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03861390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.