SYDNEY, Australia, March 14, 2007 /Xinhua-PRNewswire-FirstCall/ -- Pharmaceutical company Pharmaxis today announced the results from its Phase II trial for Aridol in subjects with Chronic Obstructive Pulmonary Disease (COPD), a respiratory disease affecting over 30 million people worldwide.
The trial was conducted in 79 diagnosed COPD patients at 12 centres in Australia. The primary objective of the trial was to determine if subjects that were positive to an Aridol challenge test would demonstrate an improvement in lung function, as measured by spirometry, following a 3 month course of inhaled corticosteroids.
A secondary objective was to determine the effect of inhaled corticosteroids on hyper-responsive airways as measured by a positive Aridol test.
In this group, with predominantly mild to moderate COPD, Aridol response was positive in 76.5% of cases. There were no related serious adverse events and Aridol was shown to have an acceptable safety profile.
As the inhaled corticosteroid did not improve lung function, as measured by spirometry, in either the Aridol positive or the Aridol negative group of subjects, the primary hypothesis could not be satisfactorily tested.
However, in subjects with a positive Aridol challenge test, treatment with inhaled corticosteroids led to a highly statistically significant improvement in hyper-responsive airways as judged by a subsequent Aridol challenge test (p< 0.004). In COPD, the severity of hyper-responsive airways is associated with the severity of the disease and is a major risk factor for the development of respiratory symptoms and worsening of the patients health.1
Pharmaxis CEO Dr Alan Robertson said: "The finding that airway
hyper- responsiveness improved in trial subjects after taking a
short course of inhaled steroids is important, and new, and
clinically valuable. The presence of hyper-responsive airways is