Trial Condition(s):
Anthrax, Bacterial Infections, Cystic Fibrosis
BAYQ3939, PK in pediatric CF patients
Bayer Identifier:
12170
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Study Completed
Trial Purpose
Primary objective:
To investigate the safety and tolerability of inhaled ciprofloxacin given as single inhalation dose to pediatric CF subjects.
Secondary objective:
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.
Inclusion Criteria
- 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%
Exclusion Criteria
- Participation in another clinical trial with antibiotic treatment during the preceding 2 weeks
- Patients with FEV1 < 50%Trial Summary
Enrollment Goal
9
Trial Dates
Phase
1
Could I receive a placebo?
No
Products
Ciprofloxacin DPI (BAYQ3939)
Accepts Healthy Volunteers
No
Where to Participate
Locations
Status
| Locations | Status |
|---|
For details, please refer to trial results
Additional Information
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