ABOUT THIS STUDY
- Informed consent and verbal assent as appropriate has been provided by the subject
- Ability to comply with medication use, study visits and study procedures as judged by the site Investigator
- Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
- > 18 years of age
- Body weight > 40 kg
- BCC present in a sputum/throat culture > 1 year prior to screening and at screening
- FEV1 % predicted > 30% as calculated by the Knudsen reference equations
- Room air oximetry > 88% at rest
- Post-menarche females must be surgically sterile or using an effective form of contraception
- Predicted to live > 1 year and clinically stable at that time of enrollment as judged by the investigator.
- History of chronic macrolide use, defined as regular macrolide antibiotic use within a
three month period prior to enrollment in the study.
- AST or ALT > 2.5 times the upper limit of normal performed at the local laboratories
on two occasions prior to randomization.
- Investigational drug use within 30 days of screening
- History of alcohol, illicit drug or medication abuse within 1 year of screening
- Use of intravenous antibiotics or oral antibiotics within 14 days of screening.
- Use of low dose oral antibiotics (e.g. macrolides, tetracycline, sulfa) for acne or
other conditions within 30 days of screening
- Use of systemic corticosteroids (> 20 mg of prednisone per day) within 30 days of
- Initiation of TOBI®, high dose ibuprofen, or rhDNase within 60 days of screening
- History of lung transplantation or currently on lung transplant list
- History of allergy to a macrolide antibiotic
- AFB smear positive at screening suggesting current NTM infection.
- Positive serum pregnancy test at screening (to be performed on all post-menarche
- Absolute neutrophil count < 1000 performed at the local laboratories on two occasions
prior to randomization
- Creatinine > 1.5 times normal performed at the local laboratories on two occasions
prior to randomization.
- Chest x-ray changes or physical findings at screening that would compromise the safety
of the patient or the quality of the study data
- Other major organ dysfunction
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