The efficacy and tolerability of fluticasone propionate (FP) 2 mg daily via a metered-dose inhaler and Volumatic (Glaxo Wellcome) spacer device was compared with nebulized budesonide (nBUD), 2 and 4 mg daily, in a multi-centre, open-label, cross-over study of adult asthmatics. Patients received, in random order, either 4 weeks of treatment with FP followed by 4 weeks of treatment with nBUD, or vice versa, with an intervening 4 week 'wash-out' period between treatments. Thirty patients completed the study, of whom 24 were evaluable. In terms of the primary efficacy parameter, change in mean morning peak expiratory flow (PEF) (l/min) from baseline to the fourth week of each treatment period, FP was more effective than nBUD (mean difference (FP-nBUD) 21.1 l/min, p = 0.007, 95% CI 6.5 to 35.7). Sub-group analysis demonstrated FP to be superior to the 4 mg nBUD (mean treatment difference (FP-nBUD) 42.9 l/min, p = 0.026, 95% CI 7.1 to 78.8) and at least as efficacious as the 2 mg nBUD sub-group (mean treatment difference (FP-nBUD) 10.2 l/min, p = 0.211, 95% CI -6.5 to 26.9). Furthermore, larger reductions in diurnal variation were observed during FP treatment (mean treatment difference (FP-nBUD) -4.4 percentage points, p = 0.028, 95% CI -8.4 to -0.5). There was no significant difference between the treatments for the proportion of symptom-free 24 h periods. Of those expressing a preference, significantly more patients found FP via a metered-dose inhaler and spacer device both easier to administer (78%, p = 0.007) and more convenient to take (76%, p = 0.008) than nebulized budesonide. In addition, cost per patient analysis showed that nebulized budesonide was from 1.7 to 3.5 times more expensive than FP.

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