Woodsmoke Particulate + Hypertonic Saline
- Conditions
- Airway Inflammation
- Registration Number
- NCT03851406
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria:<br><br> - Age 18-45 years, inclusive, of both genders<br><br> - Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy<br><br> - No history of episodic wheezing, chest tightness, or shortness of breath consistent<br> with asthma, or physician-diagnosed asthma.<br><br> - forced expiratory volume at one second (FEV1) of at least 80% of predicted and<br> FEV1/forced vital capacity (FVC) ratio of >0.70.<br><br> - Oxygen saturation of >93%<br><br> - Ability to provide an induced sputum sample.<br><br> - Subject must demonstrate a >10% increase in sputum %PMNs 6 hours following inhaled<br> WSP exposure, when compared to baseline sputum (to be completed in a separate<br> protocol IRB# 15-1775).<br><br> - Proof of vaccination to Covid based on public health guidelines at time of inclusion<br><br>Exclusion Criteria:<br><br> - Clinical contraindications:<br><br> - Any chronic medical condition considered by the PI as a contraindication to the<br> exposure study including significant cardiovascular disease, diabetes, chronic renal<br> disease, chronic thyroid disease, history of chronic infections/immunodeficiency.<br><br> - Viral upper respiratory tract infection within 4 weeks of challenge.<br><br> - Any acute infection requiring antibiotics within 4 weeks of exposure or fever of<br> unknown origin within 4 weeks of challenge.<br><br> - Abnormal physical findings at the baseline visit, including but not limited to<br> abnormalities on auscultation, temperature of 37.8° C, Systolic BP > 150mm Hg or <<br> 85 mm Hg; or Diastolic BP > 90 mm Hg or < 50 mm Hg, or pulse oximetry saturation<br> reading less than 93%.<br><br> - Physician diagnosis of asthma<br><br> - If there is a history of allergic rhinitis, subjects must be asymptomatic of<br> allergic rhinitis at the time of study enrollment.<br><br> - Mental illness or history of drug or alcohol abuse that, in the opinion of the<br> investigator, would interfere with the participant's ability to comply with study<br> requirements.<br><br> - Medications which may impact the results of the WSP exposure, interfere with any<br> other medications potentially used in the study (to include steroids, beta<br> antagonists, non-steroidal anti-inflammatory agents)<br><br> - Cigarette smoking > 1 pack per month<br><br> - Unwillingness to use reliable contraception if sexually active (IUD, birth control<br> pills/patch, condoms).<br><br> - Use of immunosuppressive or anticoagulant medications including routine use of<br> NSAIDS. Oral contraceptives are acceptable, as are antidepressants and other<br> medications may be permitted if, in the opinion of the investigator, the medication<br> will not interfere with the study procedures or compromise safety and if the dosage<br> has been stable for 1 month.<br><br> - Orthopedic injuries or impediments that would preclude bicycle or treadmill<br> exercise.<br><br> - Inability to avoid NSAIDS, Multivitamins, Vitamin C or E or herbal supplements.<br><br> - Allergy/sensitivity to study drugs or their formulations<br><br> - Positive Covid test in the past 90 days.<br><br> - Pregnant/lactating women and children (< 18 years as this is age of majority in<br> North Carolina) will also be excluded since the risks associated with WSP exposure<br> to the fetus or child, respectively, are unknown and cannot be justified for this<br> non-therapeutic protocol. Individuals over 45 years of age will not be included due<br> to the increased possibility of co-morbidities and need for prohibited medications.<br><br> - Inability or unwillingness of a participant to give written informed consent
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change From Baseline to 4 Hours in Sputum Percent Neutrophils;Change From Baseline to 24 Hours in Sputum Percent Neutrophils
- Secondary Outcome Measures
Name Time Method Change in Number of Sputum Neutrophils;Change in Number of Sputum Eosinophils;Change in Percent Sputum Eosinophils;Change in IL-1b;Change in IL-6;Change in IL-8;Change in TNFa