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 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? 1