Cystic Fibrosis Trial In Children Returns Positive Data
Pharmaxis' Phase II clinical trial in children with cystic fibrosis demonstrated excellent lung function improvement following three months treatment with Bronchitol that matched that achieved by the current marketed product rhDNase. The improvement in lung function after three months on Bronchitol reflects that seen in a previous study following two weeks of treatment.
The study was an independent investigator initiated study conducted in the United Kingdom 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 1 second) improved by: