Clinical trial: Phase I Study of the Third Generation Adenovirus H5.001CBCFTR in Patients With Cystic Fibrosis (NCT00004287)

Eligibility criteria:
PROTOCOL ENTRY CRITERIA:

        --Disease Characteristics-- Cystic fibrosis diagnosed as follows: Sweat sodium or chloride
        greater than 60 mEq/L by pilocarpine iontophoresis or cystic fibrosis genotype Clinical
        manifestations Estimated 2-year survival greater than 50%, i.e.: FEV1 at least 30% of
        predicted PaO2 greater than 55 mm Hg on room air PaCO2 less than 50 mm Hg on room air
        --Prior/Concurrent Therapy-- At least 2 months since systemic glucocorticoids At least 90
        days since participation in investigational therapeutic study --Patient Characteristics--
        Pulmonary: No pneumothorax within 12 months No asthma or allergic bronchopulmonary
        aspergillosis requiring glucocorticoids within 2 months No sputum pathogens unless
        sensitive to at least 2 antibiotics No hemoptysis of more than 250 mL blood over 24 hours
        within 1 year Other: No active adenoviral infection Ad5 (or similar type) antibody
        seropositive No other contraindication to protocol participation, e.g.: Drug abuse
        Alcoholism Psychiatric instability Inadequate motivation Documented azoospermia (men)
        Bilateral tubal ligation or hysterectomy (women) Screening exams within 4 weeks prior to
        registration
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


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? Entailment