Pseudomonas Infection

Inclusion Criteria

- Male or female patients with cystic fibrosis confirmed by genetic testing and / or by sweat  test
 - Colonization with P. aeruginosa confirmed in sputum in the past 12 months
 - Cohort 1: greater than or equal to 18 years of age.
 - Cohort 2: 6 - 12 years of age (inclusive)
 - Normal Body Mass Index: BMI between 14.5 and 30 kg/m2, but in no case lower than the 30th percentile for age. Because CF patients are typically smaller than non-CF-patients, the normal body mass index will be based on standard CF foundation normal values for weight and sex.
 - Patients who are able to understand and follow instructions and who are able to participate in the study for the entire period.
 - Patients and legal representatives must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures

Exclusion Criteria

- Patients with FEV1 < 35% of predicted. FEV1 (forced expiratory volume) is a measure of lung function. This exclusion will prohibit enrollment of patients with severely impaired lung function.
 - Patients with Burkholderia cepacia colonization of their respiratory tract
 - Patients with acute bronchopulmonary aspergillosis (ABPA)
 - Patients on a lung transplant list
 - Patients with acute pulmonary exacerbations
 - Patients with severe liver cirrhosis
 - Massive hemoptysis in the preceding 4 weeks
 - A history of relevant diseases of vital organs, of the central nervous system, or other organs not related to the underlying disease
 - Patients with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
 - Patients with hypersensitivity to the investigational drug or to other quinolones and/ or to inactive constituents
 - Patients with known intolerance to hypertonic saline or bronchodilators
 - Concomitant inhalation therapy with antibiotics and / or concomitant systemic therapy with fluoroquinolones
 - Women who are pregnant