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Phase 3 Cystic Fibrosis Trial Results Presented at European Conference
Date:6/15/2009

ek 26 with Bronchitol (p=0.001). Again, there was an immediate and sustained improvement in FEV1 over the 26 week period of the study (p=0.003). -- While the study was not powered to show a reduction in the secondary endpoint of exacerbation, the rate of a protocol defined pulmonary exacerbation (PDPE) per subject for the 26 weeks was lower for Bronchitol versus control: overall reduction in rate of 25% (p=0.2). -- There was a non significant increase in time to first PDPE (p=0.1) for the Intention to Treat group, however, for the Per Protocol population, i.e. those who were mostly compliant with therapy and stayed in the study, there was a significant increase in time to first PDPE (p=0.026). -- There was a clinically meaningful change from baseline (129mL) and control (113mL) at week 26 with Bronchitol for Forced Vital Capacity (FVC) of the lung (p=0.002). Additionally, treatment with Bronchitol showed an immediate and sustained improvement in lung capacity (FVC) over the 26 week treatment period (p<0.001). Safety -- There was a similar number of adverse events and serious adverse events per treatment group, with no deaths in the study. -- Respiratory adverse events that were more common with Bronchitol compared with placebo, included cough (25.4% versus 20.3%), haemoptysis (11.9% versus 8.5%) and pharyngolaryngeal pain (13.6% versus 4.2%). -- There were similar rates between the groups for adverse events of particular interest including: wheezing, asthma, bronchospasm (Bronchitol 4.5% versus 5.9%). -- At screening 7% of patients were ineligible to participate due to suspected undiagnosed hyperreactive airway disease. -- Overall infections were lower in the Bronchitol group (39% versus 47.5%). -- There was no difference in microbial growth for specifi
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SOURCE Pharmaxis Ltd
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