Phase 3 Clinical Trial in Bronchiectasis (B305) Fails Primary Endpoint; Meets Key Secondary Endpoints on Efficacy and Safety
Release Date: 24/04/2013 12:00am
Pharmaceutical company Pharmaxis (ASX: PXS) today announced its Phase 3 clinical trial (B305) assessing the effectiveness of Bronchitol® in people with bronchiectasis had not met the trial’s primary endpoint of demonstrating a significant difference in the rates of defined pulmonary exacerbations in patients treated over a 12 month period.
Top line results of the double blind, placebo controlled, randomised trial showed an eight (8) per cent reduction in exacerbation rates among patients treated with Bronchitol compared with control which was not statistically significant.
The positive trend in the primary endpoint was supported by a number of statistically significant secondary endpoints. These included a delay in the time to a first exacerbation, reduced days on antibiotics and improved quality of life.
The trial results show Bronchitol has an acceptable safety profile in the patient population studied with no overall difference in the numbers of patients experiencing adverse events or serious adverse events in the Bronchitol and control groups.
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