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Clinical Trial
. 2013 Jul;12(4):367-76.
doi: 10.1016/j.jcf.2012.11.002. Epub 2012 Dec 9.

Pooled analysis of two large randomised phase III inhaled mannitol studies in cystic fibrosis

Diana Bilton  1 , Gabriel Bellon, Brett Charlton, Peter Cooper, Kris De Boeck, Patrick A Flume, Howard G Fox, Charles G Gallagher, David E Geller, Eric G Haarman, Helge U Hebestreit, John Kolbe, Allen Lapey, Phil Robinson, Jian Wu, Jonathan B Zuckerman, Moira L Aitken; CF301 and CF302 Investigators
Affiliations
Free article
Clinical Trial

Pooled analysis of two large randomised phase III inhaled mannitol studies in cystic fibrosis

Diana Bilton et al. J Cyst Fibros. 2013 Jul.
Free article

Abstract

Background: To evaluate safety and efficacy of inhaled mannitol treatment in subgroups of a large global CF population.

Methods: Data were pooled from two multicentre, double-blind, randomised, controlled, parallel group phase III studies in which 600 patients inhaled either mannitol (400 mg) or control (mannitol 50 mg) twice a day for 26 weeks.

Results: Both the mean absolute change in FEV(1) (mL) and relative change in FEV(1) by % predicted from baseline for mannitol (400 mg) versus control were statistically significant (73.42 mL, 3.56%, both p<0.001). Increases in FEV(1) were observed irrespective of rhDNase use. Significant improvements in FEV1 occurred in adults but not children (6-11) or adolescents (aged 12-17). Pulmonary exacerbation incidence was reduced by 29% (p=0.039) in the mannitol (400 mg) group.

Conclusions: Sustained six-month improvements in lung function and decreased pulmonary exacerbation incidence indicate that inhaled mannitol is an important additional drug in the treatment of CF.

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