Clinical trial: A Study of Gamma Tocopherol-enriched Supplement on Lower Airway Responses to Inhaled Wood Smoke in Healthy Adults (NCT03444298)

Eligibility criteria:
Inclusion Criteria:

          1. Age 18-45 years, inclusive, of both genders

          2. Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy

          3. Forced expiratory volume at one second (FEV1) of at least 75% of predicted (without
             use of bronchodilating medications for 12 hours), consistent with lung function of
             persons with no more than mild intermittent or mild persistent asthma.

          4. Oxygen saturation of <93% and blood pressure within the following limits: (Systolic
             between 150-85 mmHg, Diastolic between 90-50 mmHg).

          5. Ability to provide an induced sputum sample.

          6. Subject must demonstrate a ≥10% increase in sputum neutrophils following inhaled WSP
             exposure, when compared to baseline sputum (to be completed in a separate protocol).

          7. Ability/willingness to discontinue inhaled corticosteroids, montelukast, and cromolyn
             for 2 weeks without increased symptoms or increased need for beta agonist rescue
             medication prior to screening and through the course of the study.

        Exclusion Criteria

        Patients who meet any of these criteria are not eligible for enrollment as study
        participants:

          1. Clinical contraindications:

               1. 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.

               2. Viral upper respiratory tract infection within 4 weeks of challenge.

               3. Any acute infection requiring antibiotics within 4 weeks of exposure or fever of
                  unknown origin within 4 weeks of challenge.

               4. 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%.

               5. Physician directed emergency treatment for an asthma exacerbation within the
                  preceding 12 months.

               6. Moderate or severe asthma

               7. Exacerbation of asthma more than 2x/weeks which would be characteristic of a
                  person with moderate or severe persistent asthma as outlined in the current
                  National Asthma Education and Prevention Program (NAEPP) guidelines for diagnosis
                  and management of asthma

               8. Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest
                  tightness) which would be characteristic of a person with moderate or severe
                  persistent asthma as outlined in the current NHLBI guidelines for diagnosis and
                  management of asthma (not to include prophylactic use of albuterol prior to
                  exercise).

               9. Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not
                  during a clearly recognized viral induced asthma exacerbation) which would be
                  characteristic of a person of moderate or severe persistent asthma as outlined in
                  the current NHLBI guidelines for the diagnosis and management of asthma.

              10. History of intubation for asthma

              11. If there is a history of allergic rhinitis, subjects must be asymptomatic of
                  allergic rhinitis at the time of study enrollment.

              12. 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.

              13. Cigarette smoking > 1 pack per month

              14. Unwillingness to use reliable contraception if sexually active (IUD, birth
                  control pills/patch, condoms).

              15. Abnormal prothrombin time (PT) or activated partial thromboplastin time (aPTT)
                  values at screening or during the treatment period. Normal values will be those
                  published by the clinical lab (Labcorp, INC).

              16. 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.

              17. Orthopedic injuries or impediments that would preclude bicycle or treadmill
                  exercise.

              18. Inability to avoid NSAIDS, Multivitamins, Vitamin C or E or herbal supplements.

              19. Allergy/sensitivity to study drugs or their formulations

              20. Known hypersensitivity to methacholine or to other parasympathomimetic agents

              21. Unwillingness to avoid coffee, tea, cola drinks, chocolate, or other foods
                  containing caffeine after midnight on the days that methacholine challenge
                  testing is to be performed.

          2. Pregnant/nursing women and children (< 18 years as this is age of majority in North
             Carolina) will also be excluded since the risks associated with woodsmoke 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.

          3. 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