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news.Pharmaxis has completed enrollment in the first pivotal Phase III clinical trial of Bronchitol for the treatment of cystic fibrosis.
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The trial is a double blind, comparator controlled, randomized study comparing 400mg of Bronchitol twice a day to control. The trial includes a 26-week efficacy and safety component, followed by a 26 week open-label Bronchitol safety extension.
The primary efficacy end-point is change from baseline in FEV1 (forced expiratory volume in one second) after 26 weeks.
The first efficacy data from the trial is expected to be available during the first half of 2009.
According to the company, Bronchitol is designed to hydrate the airway surface of the lungs, improve lung hygiene and promote normal lung clearance.
Alan Robertson, CEO of Pharmaxis, said: “It is rewarding to reach this milestone in bringing Bronchitol to the marketplace. The study has enrolled well, and we look forward to the results helping to shape cystic fibrosis clinical practice in the future.”