Bronchitol Demonstrates Dose-Related Improvements in Lung Function of
Cystic Fibrosis Patients
SYDNEY, Australia, Aug. 11 /Xinhua-PRNewswire-FirstCall/ -- Speciality pharmaceutical company Pharmaxis (ASX: PXS; Nasdaq: PXSL) today announced results from its Phase II trial, DPM-CF-202, in subjects with cystic fibrosis.
The trial achieved its primary end point of demonstrating a dose
dependent improvement in lung function as measured by FVC (forced vital
capacity) and FEV1 (the amount of air that can be forcibly exhaled in 1
second). At the end of the two-week Bronchitol treatment periods, changes
in lung function were as follows:
-- 400 mg treatment group: FEV1 increased by 8.6%
(139 mls, p=0.0006 vs 40 mg)
-- 240 mg treatment group: FEV1 increased by 4.6% (87 mls)
-- 120 mg treatment group: FEV1 increased by 3.7% (42 mls)
-- 40 mg treatment group: FEV1 decreased by -1.6% (-33 mls)
FVC changed by +7.9% on 400 mg (p=0.0004 vs 40 mg), +3.9% on 240 mg, +1.5% on 120 mg and -0.6% on 40 mg.
Pharmaxis Chief Executive Officer Alan Robertson said, "The excellent result from this trial reaffirms that the 400 mg Bronchitol dose being used in the Phase 3 trials is optimal for its clinical effectiveness. We look forward to the results from the ongoing Phase 3 studies and to bringing Bronchitol to the market as rapidly as possible."
The study was an open, randomised comparison of 400mg, 240 mg, 120 mg and 40 mg of Bronchitol in 48 patients with cystic fibrosis at 12 centres across Canada and Argentina. Bronchitol was administered twice a day for 14 days in a crossover design.
Secondary endpoints of the study included other spirometry and quality of life measures. These measures also showed a positive effect for 400 mg Bronchitol on MMEF (maximum mid expiratory flow) and the respiratory domain of the cystic fibrosis quality of life questionnaire (CFQR).
|SOURCE Pharmaxis Ltd|
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