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Pharmaxis Announces Positive Combined Phase 3 Cystic Fibrosis Trial Results
Date:10/22/2010

sive treatment with antibiotics that is now common practice in the clinic.  Despite this, Bronchitol produced a clinically relevant reduction in exacerbations in patients completing the study, and together with recent data showed sustained benefit in lung function out beyond 18 months."

Other results from CF302 presented at the NACF conference underlined both the good safety profile of Bronchitol and patient adherence.  Overall adverse events on Bronchitol were similar to those experienced on control with 7% of patients taking Bronchitol withdrawing due to adverse events compared to 4% of patients on control.  There was no increase in the numbers of bacteria present in the lungs.  The most commonly reported adverse event related to treatment was cough occurring in 6% of the Bronchitol group and 3.3% of the control group.

Moira Aitken, M.D., F.R.C.P. (Edin), Professor of Medicine, Division of Pulmonary and CCM, University of Washington, and lead principal investigator of CF302, stated, "We are excited by the results of the Bronchitol Phase III clinical program.  Across both trials, inhaled mannitol was well tolerated and demonstrated an early and sustained improvement in lung function.  This improvement in FEV1 was achieved on top of aggressive use of concomitant medications such as inhaled antibiotics and rhDNase.  These results, coupled with Bronchitol's novel formulation and portable dry powder inhaler administration, suggest that it will have a significant impact on CF patient well-being."

These conclusions were echoed by participants in CF302:

In treating CF, I take a lot of medications.  Some are pills, like different antibiotics, and some are nebulizers or inhalers such as Albuterol, Pulmozyme.  One in particular – tobramycin – I took when I was sick, but after taking Bronchitol I was able to stop that because it made such a huge difference in my pulmonary function test. K.
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SOURCE Pharmaxis
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