Clinical trial: To Identify Persons Who Are Susceptible to WSP-induced Inflammation and Examine the Role of GSTM1 and Other Factors in This Susceptibility (NCT02767973)

Eligibility criteria:
Inclusion Criteria

          1. Age 18-45 of both genders

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

          3. Calculated 10 year risk of CVD by the Framingham risk score of <5%

             Specific for Healthy Volunteers

          4. No history of episodic wheezing, chest tightness or shortness of breath consistent
             with asthma, or physician diagnoses asthma.

          5. FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70

             Specific for Allergic Asthmatic Volunteers

          6. History of episodic wheezing, chest tightness, or shortness of breath consistent with
             asthma, or physician diagnosed asthma.

          7. A POST-bronchodilator increase in FEV1 of at least 12%, OR a clinical history of
             asthma after the age of 6.

          8. FEV1 of at least 75% of predicted without use of short acting bronchodilating
             medications for 12 hours, consistent with lung function of persons with no more than
             mild episodic or mild persistent asthma.

          9. Mild persistent asthmatics must be well controlled (in accordance with NHLBI
             guidelines) and willing to discontinue Singulair, inhaled corticosteroids or cromolyn
             for a period of 2 weeks prior to study visits (except for use of cromolyn exclusively
             prior to exercise)

         10. Allergic sensitization to at least one of the following allergen preparations: (House
             Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1,
             Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive
             immediate skin test response; or a clinical history consistent with seasonal or
             perennial allergy symptoms.

         11. Subjects must be willing to avoid caffeine for 12 hours prior to all visits. Allergy
             skin testing are performed as part of IRB98-0799, which a subject must complete in
             order to be considered for this protocol.

        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, history of tuberculosis.

               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 94%.

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

               6. 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

               7. Orthopedic in juries or impediments that would preclude bicycle or treadmill
                  exercise.

               8. 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.

               9. 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).

              10. Inability to avoid NSAIDS, Multivitamins, Vitamin C or E or herbal medications in
                  the 4 days prior to the screening visit the exposure session.

              11. Symptomatic allergic rhinitis or current active allergies.

              12. Cigarette smoking > 1 pack per month

                  Specific for Healthy Volunteers

              13. Physician diagnosis of asthma.

                  Specific for Asthmatic Volunteers

              14. Physician directed emergency treatment for an asthma exacerbation within the
                  preceding 3 months

              15. Moderate or Severe asthma

              16. Exacerbation of asthma more than 2x/week which would be characteristic of a
                  person of moderate or severe persistent asthma as outlined in the current NHLBI
                  guidelines for diagnosis and management of asthma.

              17. Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest
                  tightness) which would be characteristic of a person of 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).

              18. 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 diagnosis and management of asthma

              19. History of intubation for asthma

              20. Use of systemic steroid therapy within the preceding 3 months for an asthma
                  exacerbation. All use of systemic steroids in the last year will be reviewed by a
                  study physician.

              21. Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or
                  Zafirlukast) except for use of cromolyn exclusively prior to exercise.

              22. Use of daily theophylline within the past month
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