check_circleStudy Completed

Anthrax, Bacterial Infections, Cystic Fibrosis

Bayer Identifier:

12170

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2007-002912-24

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.

Key Participants Requirements

Sex

All

Age

12 - 17 Years
  • - 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%

Trial summary

Enrollment Goal
9
Trial Dates
November 2007 - April 2008
Phase
Phase 1
Could I Receive a placebo
No
Products
Ciprofloxacin DPI (BAYQ3939)
Accepts Healthy Volunteer
No

Trial design

Study to evaluate the safety and pharmacokinetics of ciprofloxacin following inhalation of ciprofloxacin dry powder for inhalation administered to pediatric patients with cystic fibrosis aged 12 - 17 years.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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