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 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Contradiction