BAYQ3939, PK in pediatric CF patients
To investigate the safety and tolerability of inhaled ciprofloxacin given as single inhalation dose to pediatric CF subjects.
To investigate the pharmacokinetics of ciprofloxacin in plasma, urine, and sputum after inhalative administration in order to show that an exposure needed for an assumed effective treatment of P. aeruginosa can be reached in the lung of pediatric CF subjects.
- Adolescents with CF aged 12 - 17 years (BMI between 15 and 30 kg/m2) with stable pulmonary status, i.e., forced expiratory volume in 1 s (FEV1) ≥50%
- Participation in another clinical trial with antibiotic treatment during the preceding 2 weeks - Patients with FEV1 < 50%