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news.Pharmaxis' has begun dosing in its phase II trial of its drug Bronchitol in patients with cystic fibrosis. The study aims to determine the benefits of the drug in children also receiving the market leading treatment, rhDNase.
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Patients enrolled in the study, being conducted at two sites in the UK, will receive three months treatment with each of three different therapies – Bronchitol alone, both Bronchitol and rhDNase together and rhDNase alone.
The trial will measure changes in lung function, airway inflammation, infections, and quality of life. Full patient recruitment is expected to take about eight months.
Approximately 75,000 people in the major pharmaceutical markets are affected with cystic fibrosis and no products have so far been approved to improve lung hydration. A previous trial demonstrated that Bronchitol offers significant benefit for people with the condition.
“This trial will enable us to understand how Bronchitol performs in conjunction with the leading treatment for mucus clearance and help position Bronchitol in the marketplace. It’s an important study that will run in parallel with our final phase III program,” said Pharmaxis CEO Alan Robertson.