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

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)...

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Bibliographic Details
Published in:Journal of cystic fibrosis 2013-07, Vol.12 (4), p.367-376
Main Authors: Bilton, Diana, Bellon, Gabriel, Charlton, Brett, Cooper, Peter, De Boeck, Kris, Flume, Patrick A, Fox, Howard G, Gallagher, Charles G, Geller, David E, Haarman, Eric G, Hebestreit, Helge U, Kolbe, John, Lapey, Allen, Robinson, Phil, Wu, Jian, Zuckerman, Jonathan B, Aitken, Moira L
Format: Article
Language:English
Subjects:
Administration, Inhalation
Adolescent
Adult
Airway mucociliary clearance
Child
Clinical study
Cystic fibrosis
Cystic Fibrosis - drug therapy
Dry powder inhalers
Female
FEV1
Humans
Male
Mannitol - administration & dosage
Mannitol - adverse effects
Mannitol dry powder
Middle Aged
Pulmonary/Respiratory
Young Adult
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Summary: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 FEV1 (mL) and relative change in FEV1 by % predicted from baseline for mannitol (400 mg) versus control were statistically significant (73.42 mL, 3.56%, both p < 0.001). Increases in FEV1 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.
ISSN:1569-1993
1873-5010
DOI:10.1016/j.jcf.2012.11.002