Clinical trial: Woodsmoke Particulate + Prednisone (NCT03861390)

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).

        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

          -  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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Entailment