Where there's a pulse we still have life Postman Pat lol
"PHARMAXIS ANNOUNCES MILESTONE IN PHASE 3 TRIAL FOR BRONCHIECTASIS
Specialty pharmaceutical company Pharmaxis (ASX: PXS) today announced formal completion of a 52
week, Phase 3 international trial assessing the effectiveness of Bronchitol®in people with
bronchiectasis. The last participant has completed the final clinical visit in the trial which began in
October 2009.
The double blind, controlled, randomised trial recruited 485 participants and was conducted across 83
hospitals in the U.S., Europe, South America and Australia. The purpose of the trial was to examine the
efficacy and safety of 52 weeks treatment with Bronchitol in subjects with non-cystic fibrosis
bronchiectasis.
Pharmaxis Chief Executive Officer, Alan Robertson said: “This was a complex trial that collected a vast
amount of data over a long period and has already provided great insights into this under researched
patient population. We are grateful to the volunteers in the trial and are hopeful that the data will
allow us to make the benefits of Bronchitol available to a wider group of people.”
The primary endpoint of the trial was to show a significant difference in the rates of graded pulmonary
exacerbations, in patients with bronchiectasis treated with Bronchitol compared to control. Secondary
endpoints included quality of life, sputum weight and lung function as measured by spirometry.
The headline results of the trial will be available during the second quarter of 2013 following data
review and statistical analysis.
Approximately 600,000 people in the major pharmaceutical markets have bronchiectasis and no
products have been approved to assist with mucus clearance. An exacerbation is a serious life
threatening complication for patients with bronchiectasis and often leads to hospitalisation.
Moreover, an exacerbation leads to increased damage to the lungs and accelerates loss of lung
function.
A positive outcome from the trial may form the basis for an extension to the existing marketing
approvals for Bronchitol in the European Union and Australia where patients seeking treatment are
estimated at 210,000 and 18,000 respectively"
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