Objectives The objective of this study was to investigate the efficacy in children of nebulised furosemide administered singly or in combination with β-cyclodextrins (β-CDs) on asthma exacerbations.
Methods A single-blinded randomised controlled study was conducted in five groups of children with moderate asthma. Twenty children were enrolled in each group: group 1 received nebulised salbutamol, group 2 received nebulised furosemide, group 3 received both salbutamol and furosemide, group 4 received a mixture of furosemide and β-CD in a 1:0.5 molar ratio, and group 5 received a mixture of furosemide and β-CD in a 1:1 molar ratio. Pulmonary function parameters, peak flow rates, respiratory rate, oxygen saturation and clinical scores were obtained before and after treatment.
Results The primary outcome of forced expiratory volume in 1 s (FEVl) improved after drug administration in all five groups of patients. The greatest FEVl% improvement was seen in group 3 children treated with the combination of furosemide and salbutamol (22.0±1.9; p<0.001). The greatest increases in forced vital capacity (FVC) were seen in group 3 (21.6±1.6; p<0.001) and group 4 (20.9±1.8; p<0.001).
Conclusions Complexes of furosemide and CDs led to a significant increase in peak flow rate and significantly improved FEV1, FVC, respiratory rate, arterial oxygen saturation (SaO2) and clinical scores as compared to other treatments. The complex effect was nearly equal to that of the furosemide and salbutamol combination. These results suggest that CDs are a promising approach for improving the efficacy of poorly water-soluble drugs administered by inhalation.
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