Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic Fibrosis

Inclusion criteria

• Male or female patients ≥ 6 months old
• Diagnosis of cystic fibrosis (CF) based upon the following historical criteria performed prior to study participation:
• confirmed sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis (at least 2 tests), OR
• genotype with two identifiable mutations consistent with CF.
• First or early lower respiratory tract infection with Pseudomonas (P.) aeruginosa documented by either of the following:
• first infection defined by the first P. aeruginosa isolated from sputum or deep throat cough swab culture, OR
• P. aeruginosa from sputum or deep throat cough swab culture following at least 1 year of negative cultures (documented with at least 4 negative cultures during this year and no positive cultures) and no anti-pseudomonal treatment during this 1-year period, OR
• P. aeruginosa from sputum or deep throat cough swab culture following at least 2 years of negative cultures (documented with at least 2 negative cultures per year and no positive cultures) and no anti-pseudomonal treatment during this 2-year period.
• Written informed consent by the patient and/or parent/legal guardian according to local country regulations.

Exclusion criteria

• History of aminoglycoside hypersensitivity or adverse reaction to inhaled aminoglycoside.
• Signs and symptoms of acute pulmonary disease, eg, pneumonia, pneumothorax.
• Administration of any investigational drug within 30 days prior to enrollment.
• Administration of loop diuretics within 7 days prior to study drug administration.
• Personal/family history of abnormal hearing, other than typical hearing loss associated with the aging process.
• Abnormal result from an audiology testing (defined as either a unilateral pure-tone audiometry test showing a threshold elevation > 20 decibels [dB] at any frequency across the frequency range 0.25-8 kHz or the absence of emission at the evoked otoacoustic emission test).
• Positive urine pregnancy test at Day 1 (Baseline) for all female patients who have reached menarche.
• Use of macrolide antibiotics as a maintenance therapy for 12 or more days during the 28 days prior to Baseline.
• Antibody titers ≥ 1000 for any of the 3 P. aeruginosa exoenzymes: Exotoxin A, alkaline protease, or elastase (status to be determined between Baseline and Day 28).