期刊
JOURNAL OF CYSTIC FIBROSIS
卷 12, 期 4, 页码 367-376出版社
ELSEVIER
DOI: 10.1016/j.jcf.2012.11.002
关键词
Cystic fibrosis; Mannitol dry powder; FEV1; Airway mucociliary clearance; Clinical study; Dry powder inhalers
资金
- NIHR Respiratory Disease Biomedical Research Unit at the Royal Brompton and Harefield NHS Foundation Trust
- Imperial College London
- Cystic Fibrosis Foundation (CFF)
- Therapeutic Development Network (TDN)
- Pharmaxiss Limited
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. (c) 2012 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.
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