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Bronchiectasis
Regulatory Path for Bronchitol in Bronchiectasis
May 18th, 2008
Pharmaxis (AXS: PSX; Nasdaq: PXSL) announced that it has agreed with advice from the U.S. Food and Drug Administration (FDA) on the design of a pivotal Phase 3 trial of the company's mucus clearing agent, Bronchitol, in patients with bronchiectasis. The trial is a randomized, double-blind investigation of Bronchitol twice daily in approximately 300 adults with bronchiectasis. Participants will be treated for 52 weeks during which they will be assessed for reduction in frequency of exacerbations and quality of life. The trial will be undertaken in Europe and the USA. This trial is the second Phase III study to be undertaken with Bronchitol in people...
Source: Medical Letter on the CDC & FDA (2008-05-18)
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