European CF Clinical Trial in Paediatric Patients Begins

20th Jun 13

Release Date: 20/06/2013 12:00am

Pharmaceutical company Pharmaxis (ASX:PXS) today announced that it has enrolled the first subject into its European paediatric clinical trial evaluating Bronchitol® in cystic fibrosis.

The Phase 2 trial being conducted in Europe and Canada is a requirement of Bronchitol’s earlier European marketing approval for adults and if positive will form part of an application to extend this approval to treat children and adolescents in the EU with cystic fibrosis.

The trial is a 27 week randomised, double-blind crossover investigation of Bronchitol administered twice daily in approximately 160 patients with cystic fibrosis.  The trial is enrolling cystic fibrosis patients aged 6 to 17 years and will assess improvements in lung function, treatment induced sputum weight and safety.

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