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Pharmaxis starts patient enrolment in Aridol COPD trial

Sydney, AustraliaMonday, May 21, 2007, 08:00 Hrs  [IST]

Pharmaxis has announced that the first patients have been enrolled in a Swiss clinical trial evaluating the ability of Aridol to predict the response to inhaled steroids in patients with Chronic Obstructive Pulmonary Disease (COPD). The independent investigator-led trial will test the hypothesis that patients with COPD are more likely to have a good clinical response to inhaled steroids if they have a positive Aridol challenge test. The global prescribing guidelines recommend the use of steroids only for patients with moderate to severe COPD. COPD is a lung disease in which the lungs are damaged, restricting airflow and making it difficult for sufferers to breathe. COPD is a major cause of illness and the fourth leading cause of death in the developed world. Pharmaxis CEO, Alan Robertson said, "When to add inhaled steroids to bronchodilator therapy in COPD remains an important clinical dilemma and it is not ideal to wait until the patient has developed severe disease. To date, there is no proven method available to guide physicians in this decision. We believe that an early and objective indicator could lead to changes in treating one of the world's most prevalent diseases affecting over 20 million people in the US alone." The trial follows on from two earlier studies: a pilot study by the same investigator, and an Australian phase II trial completed by Pharmaxis earlier this year. The trial will follow a larger group of patients diagnosed with COPD and receiving baseline bronchodilator therapy with Spiriva. The trial is scheduled to complete during the first half of 2008. After a one month period during which patients inhale Spiriva alone, the 100 participants will be tested with Aridol then randomised to receive inhaled steroids or placebo. Lung function, response to Aridol, exacerbations and changes in quality of life will be measured at the end of the trial.

 
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