Clinical trial: NAC Phase IIB: A Multi-Center, Phase IIB, Randomized, Placebo-controlled, Double-Blind Study Of The Effects Of N-Acetylcysteine On Redox Changes and Lung Inflammation In Cystic Fibrosis Patients (NCT00809094)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female 7 years of age or older

          2. Diagnosis of CF based upon the following criteria:

               1. One or more clinical features characteristic of CF AND (b or c)

               2. Positive sweat test > 60 mEq/L by quantitative pilocarpine iontophoresis

               3. A genotype with two identifiable mutations consistent with CF

          3. Written informed consent (and assent when applicable) obtained from subject or
             subject's legal representative

          4. Clinically stable with no evidence of acute upper or lower respiratory tract infection
             within 4 weeks prior to enrollment

          5. Stable mild or moderately severe lung disease defined by an FEV1 > or = 40% and < or =
             85% predicted for age based on the Wang (males < 18 years, females < 16 years) or
             Hankinson (males > or = 18 years, females > or = 16 years) standardized equations

          6. Able to tolerate sputum induction with 3% hypertonic saline and to expectorate

          7. Able to perform repeatable, consistent efforts in pulmonary function testing

          8. Weight > or = 25 kg at time of enrollment

          9. Females of child bearing potential must be willing to use birth control (IUD, oral,
             transdermal, or parenteral contraceptives; abstinence)

        Exclusion Criteria:

          1. Clinically significant liver enzymes (AST, ALT or GGT) > 2.5 times the upper limit of
             normal at screening

          2. History of ABPA, unless have evidence of a stable IgE (< 5% increase compared to
             previous test) for 6 months prior to enrollment

          3. Current or history of rheumatic or collagen vascular disorders

          4. Use of NSAIDS other than for chronic therapy within 1 week prior to enrollment

          5. Initiation of chronic therapy with ibuprofen, azithromycin, TOBI® or Aztreonam within
             6 weeks prior to enrollment

          6. Consumption or inhalation of antioxidants (including NAC, GSH, Immunocal, Nacystelyn,
             pentoxyfilline) within 6 weeks prior to enrollment

          7. Use of oral or IV corticosteroids within 4 weeks prior to enrollment

          8. Use of acetaminophen within 3 days prior to enrollment

          9. Unable to forego during the study:

               -  Vitamin E: more than 400 IU/day for subjects < or = 12 years of age and 800
                  IU/day for subjects > 12 years of age

               -  Vitamin C: more than 0.5 gm/day

               -  More than two alcoholic drinks per day

         10. Known hypersensitivity to oral PharmaNAC®

         11. Current cigarette consumption

         12. Pregnant or breastfeeding

         13. Subject unlikely to complete the study as determined by the Investigator

         14. Any condition that the Investigator believes would interfere with the intent of this
             study or would make participation not in the best interest of the subject

         15. Participation in trials for other anti-inflammatory or therapeutic investigational
             drugs within 6 weeks prior to enrollment
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.


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? 1