Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Stanford University
With
Cystic Fibrosis Foundation
Age
7–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
