9year low..., page-25

Hmmm doesn't look too promising on face value

The most relevant clinical data is the 12 week study Pharmaxis undertook in bronchiectasis. This study was completed in 2007 and compared a 320 mg twice daily dose of mannitol against a sugar crystal control. The study was in patients with mild to moderate disease severity. The study demonstrated statistical significance in mucus movement vs. control (p value 0.002) as one of its primary end-points. The study did not achieve statistical significance vs. control in the St George Quality of Life Questionnaire (p value 0.304) which was also a primary end-point. There was little change in lung function as measured by FEV1 for both mannitol and control. The 12 week study was not powered to showed exacerbation benefit and there were not allot of protocol defined pulmonary exacerbation's ('PDE') with 0.12 per patient in Mannitol and 0.098 per patient in Control. The study has a definition of pulmonary defined exacerbation (PDE) as greater than 24 hour deterioration in atleast three respiratory systems (cough, dyspnoea, haemoptysis, sputum purulence, sputum volume, chest pain). The patient and control groups had lung functions as measured by FEV1 of circa 75 percent

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