check_circleStudy Completed
Anthrax, Bacterial Infections, Cystic Fibrosis
Bayer Identifier:
12170
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
BAYQ3939, PK in pediatric CF patients
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.
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.
Key Participants Requirements
Sex
AllAge
12 - 17 YearsTrial summary
Enrollment Goal
9Trial Dates
November 2007 - April 2008Phase
Phase 1Could I Receive a placebo
NoProducts
Ciprofloxacin DPI (BAYQ3939)Accepts Healthy Volunteer
NoTrial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A