The study was an independent investigator initiated study conducted in the UK in 20 children with a mean age of 13 years. Those children enrolled in the trial completed three months treatment with each of three different therapies, Bronchitol alone, both Bronchitol and rhDNase together and rhDNase alone. The trial measured changes in lung function, airway inflammation, infections, and quality of life.
At the end of the treatment period, lung function as determined by measuring FEV1 (the amount of air that can be forcibly exhaled in one second) improved by, 7% while the subjects were on Bronchitol, 7% while subjects were on rhDNase and 2% while subjects were on both agents together.
Alan Robertson, CEO of Pharmaxis, said: “While not on the regulatory approval path, this is the first time we have had an opportunity to measure the performance of Bronchitol following three months continuous treatment and it bodes well for the pivotal six month Phase III trial that is currently in progress. Although the two agents worked less well when taken together, the patient numbers are low and a previous study has shown a benefit to using both therapies together.”