IS HIGH-DOSE FLUTICASONE PROPIONATE VIA A METERED-DOSE INHALER AND VOLUMATIC(TM) AS EFFICACIOUS AS NEBULIZED BUDESONIDE IN ADULT ASTHMATICS

The efficacy and tolerability of fluticasone propionate (FP) 2 mg dail y via a metered-dose inhaler and Volumatic(TM) (Glaxo Wellcome) spacer device was compared with nebulized budesonide (nBUD), 2 and 4 mg dail y, 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 patie nts completed the study, of whom 24 were evaluable. In terms of the pr imary efficacy parameter, change in mean morning peak expiratory flow (PEF) (l min(-1)) from baseline to the fourth week of each treatment p eriod, FP was more effective than nBUD [mean difference (FP-nBUD) 21.1 l min(-1), P=0.007, 95% CI (6.5, 35.7)]. Sub-group analysis demonstra ted FP to be superior to the 4 mg nBUD [mean treatment difference (FP- nBUD) 42.91 l min(-1), P=0.026, 95% CI (7.1, 78.8)] and at least as ef ficacious as the 2 mg nBUD sub-group [mean treatment difference (FP-nB UD) 10.2 l min(-1), P=0.211, 95% CI (-6.5, 26.9)]. Furthermore, larger reductions in diurnal variation were observed during FP treatment [me an treatment difference (FP-nBUD) -4.4 percentage points, P=0.028, 95% CI (-8.4, -0.5)]. There was no significant difference between the tre atments for-the proportion of symptom-free 24 h periods. Of those expr essing a preference, significantly more patients found FP via a metere d-dose inhaler and spacer device both easier to administer (78%, P=0.0 07) and more convenient to take (76%; P=0.008) than nebulized budesoni de. In addition, cost per patient analysis showed that nebulized budes onide was from 1.7 to 3.5 times more expensive than FP.