Pharmaceutical company Pharmaxis 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.
Management of the trial is outsourced to INC, a global contract research organisation with significant experience running international trials in the cystic fibrosis community. More than 100 sites across 19 countries will participate in the study and recruitment is expected to take twelve months to complete.
Pharmaxis CEO Mr Gary Phillips said, “This Phase 3 trial in adults has been carefully designed with the benefit of our two previous CF trials (CF301 and CF 302) where a post hoc analysis1 of the subgroups of adult patients showed a significant improvement in FEV1. The design of the trial also incorporates the very clear guidance provided by the FDA concerning what is required in order to gain approval for Bronchitol in the US. We are very pleased to have enrolled the first patient.”
Bronchitol is a precision spray‐dried form of mannitol, delivered to the lungs by a specially designed, portable inhaler. The product is approved for marketing for patients aged over six years in Australia and for patients aged 18 years and over throughout the European Union and in Israel.
Read the original story http://www.pharmaxis.com.au/news/nc/Media_2014/n/phase-3-clinical-trial-in-cystic-fibrosis-begins-141030 which was published on 30th October 2014.