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

Trial ID or NCT#

NCT00809094

Status

not recruiting iconNOT RECRUITING

Purpose

This Phase IIB proof-of-concept study would examine the effects of an investigational product called N-acetylcysteine (NAC) on the basic processes that cause inflammation in CF lung disease. We hope to learn more about the causes of lung disease in cystic fibrosis by studying the characteristics of the inflammation in the lungs of patients who have CF.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 7 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Male or female 7 years of age or older2. Diagnosis of CF based upon the following criteria:
  2. 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 CF3. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative4. Clinically stable with no evidence of acute upper or lower respiratory tract infection within 4 weeks prior to enrollment5. 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 equations6. Able to tolerate sputum induction with 3% hypertonic saline and to expectorate7. Able to perform repeatable, consistent efforts in pulmonary function testing8. Weight \> or = 25 kg at time of enrollment9. Females of child bearing potential must be willing to use birth control (IUD, oral, transdermal, or parenteral contraceptives; abstinence)
Exclusion Criteria:
  1. 1. Clinically significant liver enzymes (AST, ALT or GGT) \> 2.5 times the upper limit of normal at screening2. History of ABPA, unless have evidence of a stable IgE (\< 5% increase compared to previous test) for 6 months prior to enrollment3. Current or history of rheumatic or collagen vascular disorders4. Use of NSAIDS other than for chronic therapy within 1 week prior to enrollment5. Initiation of chronic therapy with ibuprofen, azithromycin, TOBI® or Aztreonam within 6 weeks prior to enrollment6. Consumption or inhalation of antioxidants (including NAC, GSH, Immunocal, Nacystelyn, pentoxyfilline) within 6 weeks prior to enrollment7. Use of oral or IV corticosteroids within 4 weeks prior to enrollment8. Use of acetaminophen within 3 days prior to enrollment9. Unable to forego during the study:
    1. * 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 day10. Known hypersensitivity to oral PharmaNAC®11. Current cigarette consumption12. Pregnant or breastfeeding13. Subject unlikely to complete the study as determined by the Investigator14. 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 subject15. Participation in trials for other anti-inflammatory or therapeutic investigational drugs within 6 weeks prior to enrollment
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Investigator(s)

Carol Conrad

View on ClinicalTrials.gov