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news.Pharmaxis has completed the 12 month Phase III clinical trial evaluating the safety of Bronchitol in 100 subjects with bronchiectasis.
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This 12-month treatment period was an open label extension to a three- month efficacy trial which has already reported, showing that Bronchitol improved quality of life and mucus clearance. The objective of the open label extension is to determine the adverse event profile of Bronchitol following prolonged use.
Bronchitol is being developed as a twice daily inhalation therapy for people with the incurable lung condition bronchiectasis. Following statistical analysis, the results from this second phase of the trial will be reported in July 2008.
Alan Robertson, CEO of Pharmaxis, said: “Following receipt of the study report, Pharmaxis intends filing its first marketing application in Australia for Bronchitol next quarter.”