Inhaled Ciproflaxin Versus Placebo in subjects with Cystic Fibrosis

• Research type

  Research Study

• Full title

  Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis

• IRAS ID

  19333

• Contact name

  David Honeybourne

• Sponsor organisation

  Bayer Healthcare AG

• Eudract number

  2008-008314-40

• Clinicaltrials.gov Identifier

  NCT00645788

• Research summary

  This research is funded by Bayer Healthcare and has been designed to test whether nebulized ciprofloxacin (study drug) is safe and effective in subjects with cystic fibrosis (CF). CF is an autosomal recessive disorder that occurs in approximately 1 in 2500 live births and is associated with significant morbidity, mortality and reduction of life expectancy.The primary cause of morbidity and mortality in subjects with CF is progressiveobstructive lung disease associated with chronic infection with Pseudomonas aeruginosa. This study will test novel nebulized antibiotic treatment in clinically stable patients chronically colonised with P. aeruginosa. Ciprofloxacin is known to have bactericidal activity against P. aeruginosa and is used systemically in managing CF exacerbations. The limitation of this therapy is insufficient concentration of the drug in the lung tissue with systemic drug administration. The study objective is to test the safety and efficacy of the nebulized form of the drug, administered with a proprietary device in treating chronic P. aeruginosa infection in CF patients. Currently only one nebulized antibiotic treatment for CF is approved - tobramycin. This treatment is administered continuously for 28 days followed by a 28 day interval. The limitations of this treatment are development of antibiotic resistance and potential toxicity associated with chronic treatment with aminoglycoside antibiotic.The study will be randomized, double-blind and placebo controlled. 210 patients will be enrolled in the US, Canada, Europe, Israel and Australia. The patients will be randomized to obtain a 1:1:1 distribution (2 active and 1 placebo arms) to one of 4 possible treatment arms (2 doses of study drug Ciprofloxacin PulmoSphere© Inhalation Powder 50 or 75 mg, equivalent to ciprofloxacin betaine 48,75 mg and 32,5 mg respectively and 1 matching placebo arms which will be split into 2 groups to match 2 doses of the study medication). The study protocol includes 8 clinic visits and 1 telephone visit over a period of 92 days. Patients will begin the study with a 30 day washout period to eliminate any current anti-pseudomonal antibiotic treatments. Patients will then enter a 28-30 day treatment period followed by a 28-30 day follow up period.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  09/H0402/56

• Date of REC Opinion

  18 May 2009

• REC opinion

  Further Information Favourable Opinion