Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
6–12
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
