Clinical trial: Study of Airway Inflammatory Responses to Experimental Rhinovirus Infection (NCT03508479)

Eligibility criteria:
Inclusion Criteria:

          1. Age 18-45 years of either gender

          2. Non-smoker (less than 10 cigarettes per month for at least the prior 3 years)

          3. Negative pregnancy test (for females as applicable)

          4. Oxygen saturation of > 94% and blood pressure with systolic value between 140-90 mm Hg
             and diastolic between 80-55 mm Hg

          5. Willingness to hold all nasal medications (including, but not limited to, nasal
             steroids or nasal spray decongestants), oral antihistamines and leukotriene inhibitors
             for at least 1 week prior to Day 0 and continuing throughout the remaining study
             period.

          6. Negative Allergy Skin Test (AST) at a separate screening visit performed prior to
             study enrollment, University of North Carolina Institutional Review Board (UNC IRB)
             approved study # 98-0799, Database and Screening Protocol for Research Studies of the
             Center for Environmental Medicine and Lung Biology (CEMALB). (Results from AST
             performed within the past 12 months as part of another study protocol or AST reports
             from testing performed by the subject's Medical Doctor (MD) within the past 12 months
             will also be accepted.)

          7. Negative methacholine inhalation challenge as performed in the separate screening
             protocol. (Less than a 20% decrease in Forced Exhaled Volume at 1 second (FEV1) at a
             maximum methacholine concentration of 10 mg/ml).

          8. Normal lung function, defined as (NHANES III predicted set):

               -  Forced Vital Capacity (FVC) of ≥ 80 % of that predicted for gender, ethnicity,
                  age and height

               -  FEV1 of ≥ 80 % of that predicted for gender, ethnicity, age and height

               -  Ratio of Forced Exhaled Volume at 1 second to Forced Vital Capacity (FEV1/FVC) ≥
                  .75

          9. No nasal symptoms, based on respiratory questionnaire

        Exclusion Criteria:

          1. Presence of neutralizing antibodies to RG-HRV-16 at the screening visit to a titer of
             ≥ 1:2.

          2. Inability or unwillingness of a participant to give written informed consent

          3. History of rhinitis, chronic sinusitis, or other sinus disease, or any chronic
             cardiorespiratory disease

          4. Subjects with household contacts with chronic lung disease, who are children under the
             age of 2 years, and who are adults over the age of 65 years

          5. Subjects who live in communal settings (i.e. dormitories)

          6. Respiratory infection (cough, sore throat, sinusitis, fever etc) within prior 4 weeks

          7. Received any live vaccine in the past 4 weeks or an inactivated vaccine within the
             past 2 weeks

          8. Active wheezing at the time of the Day 0 visit

          9. Pregnancy or nursing or women who are currently trying to become pregnant; all female
             subjects, except those who have had a hysterectomy with oophorectomy, will undergo
             urine pregnancy testing on the morning of the screening visit and again on the on Day
             0 at the time of arrival to the lab and prior to HRV administration. A positive
             pregnancy test will exclude the subject

         10. History of any immunosuppressive disease or a positive Human immunodeficiency virus
             (HIV) test at the screening visit

         11. Use of immunosuppressive drugs within the past 6 months

         12. Chronic medications which, in the opinion of the study physician(s), may either
             increase the risks of participation or may interfere with the findings of the study

         13. Current use of beta-adrenergic blocking agents

         14. Current use of antidepressants if classified as tricyclic or Monoamine oxidase
             inhibitors (MAO) inhibitors;

         15. Known hypersensitivity to methacholine or to other parasympathomimetic agents;

         16. History of fainting or feeling severely dizzy with blood draws

         17. History of Guillain-Barre syndrome

         18. Subjects who will be unable to avoid contact with immunocompromised individuals for 3
             weeks after receiving RG-HRV16

         19. Past or current medical problems or findings from physical examination or laboratory
             testing that are not listed above, which, in the opinion of the investigator, may pose
             additional risks from participation in the study, may interfere with the participant's
             ability to comply with study requirements or that may impact the quality or
             interpretation of the data obtained from the study;

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

         21. 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

         22. Participation in any study using an investigational agent within 30 days of
             enrollment.
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