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
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.
• Male or female 7 years of age or older
• Diagnosis of CF based upon the following criteria:
• One or more clinical features characteristic of CF AND (b or c)
• Positive sweat test > 60 mEq/L by quantitative pilocarpine iontophoresis
• A genotype with two identifiable mutations consistent with CF
• Written informed consent (and assent when applicable) obtained from subject or subject's legal representative
• Clinically stable with no evidence of acute upper or lower respiratory tract infection within 4 weeks prior to enrollment
• 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
• Able to tolerate sputum induction with 3% hypertonic saline and to expectorate
• Able to perform repeatable, consistent efforts in pulmonary function testing
• Weight > or = 25 kg at time of enrollment
• Females of child bearing potential must be willing to use birth control (IUD, oral, transdermal, or parenteral contraceptives; abstinence)