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

Author(s): Bilton D(1), Bellon G, Charlton B, Cooper P, De Boeck K, Flume PA, Fox HG, Gallagher CG, Geller DE, Haarman EG, Hebestreit HU, Kolbe J, Lapey A, Robinson P, Wu J, Zuckerman JB, Aitken ML; CF301 and CF302 Investigators.

Affiliation(s): Author information: (1)Royal Brompton Hospital, London, United Kingdom. d.bilton@rbht.nhs.uk

Publication date & source: 2013, J Cyst Fibros. , 12(4):367-76

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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