Clinical trial: Aztreonam Aerosol to Treat Cystic Fibrosis Nasal Disease (NCT02730793)

Eligibility criteria:
Inclusion Criteria:

          1. Males or females 7 years of age or older and able to perform pulmonary function
             testing

          2. Confirmed diagnosis of CF by the 1997 CF Consensus Conference criteria and followed by
             the VCU or EVMS CF clinic

          3. Presence of PA in 2 lower respiratory tract (sputum) cultures in the 24 months before
             screening

          4. Subjects and/or parent guardian must be able to give written informed consent prior to
             any study related procedure

          5. All sexually active female subjects who are of childbearing potential must agree to
             use an effective method of contraception (i.e.condoms or abstinence).

          6. All sexually active female subjects must have a negative pregnancy test at screening
             (V0).

          7. Clinically stable determined by the study physician with no significant new
             respiratory symptoms.

          8. Presence of PA in nasal culture (swab or secretion) or sinus culture obtained in the
             12 months before screening or at screening visit

        Exclusion Criteria:

          1. Use of oral, IV or inhaled antibiotics within 0 days before study other than low dose
             azithromycin

          2. Severe pulmonary disease with FEV1<30% predicted of baseline SpO2<0.90

          3. ENT surgery within 6 months of screening

          4. Allergy or documented adverse reaction to aztreonam

          5. Epistaxis or significant (>30mL) hemoptysis in the past 6 months

          6. Frequent (weekly or more frequently) or severe headaches

          7. Subject is unlikely to comply with the procedures scheduled in the protocol

          8. Subject participates in another clinical trial within 30 days prior to study entry

          9. Subjects who have had a lung transplant will be excluded

         10. Prisoners will be excluded

         11. Non-English Speaking patients will be excluded
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
Subject must be at most 100 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? Entailment