Phase 3 Clinical Trial in Cystic Fibrosis Begins
Release Date: 30/10/2014 12:00am
Pharmaceutical company Pharmaxis (ASX: PXS) today announced that it has enrolled the first subject in its international clinical trial evaluating Bronchitol® in adults with cystic fibrosis (CF303).
The Phase 3 trial is being conducted in accordance with the requirements of the US Food and Drug Administration (FDA) to gain approval for Bronchitol (mannitol) to treat cystic fibrosis in the United States. As guided by the FDA, the clinical study protocol closely follows the design of the two large scale clinical trials already undertaken by Pharmaxis (CF 301 and CF 302). The trial is a 26 week randomised, double-blind parallel group investigation of Bronchitol administered twice daily in patients with cystic fibrosis. The trial will enroll between 350 and 440 cystic fibrosis patients aged 18 years and older, and will assess improvements in lung function, pulmonary exacerbations and safety.
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