A total of 123 subjects started treatment with 320mg Bronchitol twice per day and 99 subjects completed the full 12 months of the trial. Of the 24 withdrawals, only seven were a result of adverse events (three related to lung infections and two related to cough).
This 12-month treatment period was an open-label extension to a three-month efficacy trial which was reported in the second half of 2007.
The conclusion from this trial is that Bronchitol improves quality of life and mucus clearance following three months of treatment and is safe and well tolerated following 12 months of treatment.
Bronchitol is being initially developed as a twice daily inhalation therapy for people with the incurable lung conditions bronchiectasis and cystic fibrosis.
Alan Robertson, CEO of Pharmaxis, said: “Pharmaxis intends to file a marketing application in Australia for Bronchitol as soon as possible now that this study has concluded satisfactorily. We are looking forward to bringing Bronchitol to the marketplace and are delighted this trial has concluded successfully.”