Clinical trial: Effects of Wood Smoke Particles on Influenza-induced Nasal Inflammation in Normal Volunteers (NCT02183753)

Eligibility criteria:
Inclusion Criteria:

          1. Normal lung function, defined as (Knudson 1976/1984 predicted set): FVC > 75 %
             predicted for gender, ethnicity, age and height; FEV1 >75 % predicted ; FEV1/FVC ratio
             >0.70 and < 0.90.

          2. Oxygen saturation of > 94%

          3. Normal blood pressure (Systolic between 140 - 90, Diastolic between 90-60 mm Hg)

          4. Symptom Score no greater than 6 (out of a possible 39) for total symptom score

          5. On the day of a challenge, body temperature must be no greater than 37.8 degrees,
             measured orally

        Exclusion Criteria:

          1. A history of significant chronic illnesses (to include diabetes, autoimmune diseases,
             immunodeficiency state, known ischemic heart disease, chronic respiratory diseases
             such as chronic obstructive pulmonary disease or asthma, hypertension)

          2. Positive pregnancy test within 48 hours of the time of challenge

          3. Use of any inhaled substance (for medical or recreational purposes). Nonsmokers must
             have been abstinent from smoking for the prior 12 months, having not smoked more than
             1 pack over the course of the previous year and does not smoke at all 1 week prior to
             entrance in the study.

          4. Receipt of LAIV in the current season

          5. History of allergy to eggs

          6. Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or
             bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally
             resolved symptomatically for 3 weeks

          7. Unspecified illnesses, which in the judgment of the investigator increase the risk
             associated with the experimental LAIV infection, will be a basis for exclusion.

          8. Expected exposure of subject to immunocompromised individuals (who can be infected by
             LAIV) for the 3 weeks following LAIV inoculation
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 40 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