Clinical Trial: Cipro Inhaler for Cystic Fibrosis Children Ages 6-12

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Study to Evaluate the Safety and Pharmacokinetics of Ciprofloxacin in Adults and Children Aged 6 - 12 Years With Cystic Fibrosis Following Inhalation of Ciprofloxacin Dry Powder

Brief Summary: Ciprofloxacin PulmoSphere Inhalation Powder appears to be an effective and adequate antibiotic treatment for cystic fibrosis patients with P. aeruginosa colonisation. This planned study is the first study on the use of this new Ciprofloxacin PulmoSphere Inhalation Powder in the pediatric population of 6 to 12 years of age.

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: To investigate the safety and tolerability of inhaled ciprofloxacin given as single inhalation dose to pediatric CF patients, aged 6 - 12 years [ Time Frame: Two weeks post screening ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To investigate the pharmacokinetics of ciprofloxacin in plasma and sputum after inhalation administration [ Time Frame: Day 1 ]

Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: May 28, 2009
Date Started: July 2009
Date Completion:
Last Updated: November 20, 2013
Last Verified: November 2013