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Sustained improvement in lung function compared with control1-4

Summary

Lung function

  • Based on pooled data from two large phase III studies, significant FEV1 improvement on top of standard care compared with control:1
    • 99.5 mL mean difference in FEV1 for Bronchitol vs control over 26 weeks (p<0.001)1
    • 6% difference in FEV1 with Bronchitol vs control at 26 weeks (p=0.002)6
    • A significant difference of 89.8mL in FEV1 with Bronchitol vs. control was seen as early as 6 weeks (p=0.001)8
  • 30 minutes after the first dose, Bronchitol-treated patients had produced significantly more sputum (p<0.0001 vs. control)8
    • Continued effect on mucus clearance at 14 weeks with a significantly greater sputum weight with Bronchitol vs. control (p<0.0015 vs. control)8

Convenience

  • Dry powder inhaler9
  • Easy to use, discrete and portable
  • No refrigeration or nebuliser required9
26 weeks

99.5 mL mean difference in FEV1 for Bronchitol vs control over 26 weeks (p<0.001)1

6% difference in FEV1 with Bronchitol vs control at 26 weeks (p=0.002)6

FEV1 Graph
Adapted from Pharmaxis data on file.5 95% CI shown.
At baseline Bronchitol n= 207, control n=134. At 52 weeks Bronchitol n=111, Bronchitol (ex-control) n=73
Bronchitol vs control * p<0.00119 ** p=0.00619 *** p<0.00119
52 weeks

Benefits sustained over 1 year4,5

“Mannitol treatment provides both early and sustained clinically meaningful improvements in airway function over and above the existing standard care, irrespective of concomitant rhDNase use, in a representative population of CF subjects.”2

1. Flume P et al. Breathe 2015; 11: 39-48. 2.Bilton D et al. Eur Respir J 2011; 38: 1071-1080. 3.Aitken ML et al. Am J Respir Crit Care Med. 2012; 185(6): 645-652. 4.Bilton D et al. Poster: Phase III Study of Inhaled Dry Powder Mannitol (BronchitolTM) in Cystic Fibrosis – Results from the 12 month Open Label Phase. ECFS Valencia 2010. 5.Pharmaxis data on file: fe01chg3_204 FEV1 by visit during DBP and OLP. 6.Pharmaxis data on file: fe01mma9_201 Mixed Model Repeated Measures Analysis of Percentage Change from Baseline in FEV1 by Age Group at Screening. 7.Robinson M et al. Eur Respir J 1999; 14: 678-685. 8.Aitken M et al. Bronchitol (Inhaled Dry Powder Mannitol) in Adult Patients with Cystic Fibrosis. Poster presented at ECFS 2012, Dublin, Ireland. 9.Bronchitol Summary of Product Characteristics (see link below).

Adverse events should be reported to Pharmaxis Ltd by email: adverse.events@pharmaxis.com.au.