Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis

Inclusion Criteria

• Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride greater than 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
• Patient must be known to be chronically colonized with Aspergillus fumigatus.
• Patients must be clinically stable at randomization, no use of new inhaled, oral or intravenous antibiotics or oral or intravenous corticosteroids during the 14-day period prior to randomization.
• 6 years of age and older
• Patients must weigh at least 20 kg
• Post-menarche females must be using an effective form of contraception.

Exclusion Criteria

• Inability to give informed consent.
• Respiratory culture positive for B.cepacia complex
• Renal function abnormalities-Creatinine greater than 1.5 times upper limit of normal within a 30 day period prior to randomization
• Liver function abnormalities : AST or ALT greater or equal to 2.5 times the upper limit of normal within a 30 day period prior to randomization
• Neutropenia, absolute neutrophil count< or = 1000 within a 3-day period prior to randomization
• History of biliary cirrhosis documented by liver biopsy or imaging.
• History of portal hypertension.
• Investigational drug use within 30 days of randomization date.
• History of alcohol, illicit drug or medication abuse within 1 year of randomization.
• Women who are pregnant, breastfeeding or trying to conceive