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news.Pharmaxis has completed the efficacy phase of its global phase III clinical trial of Bronchitol in bronchiectasis, and plans to seek market approval if positive results are achieved.
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The placebo controlled trial, conducted at 22 hospitals across Australia, New Zealand and the UK, evaluated the impact of Bronchitol on mucus clearance, disease symptoms, cough severity, exercise capacity and lung function.
Participants received either Bronchitol or placebo for three months, at which point the effect of treatment was assessed. An extension of the trial allows participants access to Bronchitol for a total of twelve months to determine the safety of long term Bronchitol treatment. This second component of the trial is fully recruited and will complete in 2008.
The outcome from the trial will be available this quarter after the individual patient data has been checked, the study unblinded and the statistical analysis completed.
There have been no new therapeutic advances for this patient group in the last twenty years. Bronchiectasis is an incurable, degenerative and chronic lung condition affecting more than half a million people in the western world alone.