SYDNEY, June 16 /PRNewswire-Asia/ -- Pharmaceutical company Pharmaxis (ASX: PXS; Nasdaq: PXSL) is pleased to announce that additional results of its recently completed international Phase III trial of Bronchitol in patients with cystic fibrosis have been presented at the 2009 European Cystic Fibrosis Conference in Brest, France.
The results were presented to the conference on Friday 12 June by Dr Diana Bilton of the Royal Brompton Hospital, London.
The trial was a multi-centre, randomised, double blind, placebo controlled, 26 week study, with an optional further 6 month open label uncontrolled period. It was conducted in 40 centres in the United Kingdom, Ireland, Australia and New Zealand.
The primary endpoint of the trial was to assess whether Bronchitol improves lung function as measured by a change in FEV1 when administered twice per day for six months.
The key secondary endpoint of the trial was to assess whether Bronchitol further improves lung function in patients already being treated with the most commonly used CF therapeutic, rhDNase. Additional endpoints included changes in the Forced Vital Capacity of the lung, pulmonary exacerbations and antibiotic use.
Safety evaluation included the incidence of adverse events and the microbiology of sputum samples.
Clinical Results -- There was a clinically meaningful change from baseline (119mL) and placebo (93mL) at week 26 with Bronchitol for FEV1 (p<0.001). Importantly, treatment with Bronchitol showed an immediate and sustained improvement in lung function (FEV1) over the 26 weeks (p<0.001). -- For the subgroup of patients on concomitant rhDNase there was also a significant improvement in FEV1 from baseline (88mL) and from placebo (109mL) at we
|SOURCE Pharmaxis Ltd|
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