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Friday 25 May 2007

Efficacy and Safety of Salmeterol/Fluticasone Propionate Combination Delivered by the Diskustrade mark or Pressurised Metered-Dose Inhaler in Children with Asthma.

By: Bracamonte T, Schauer U, Emeryk A, Godwood A, Balsara S.

Clin Drug Investig 2005 ;25(1):1-11

BACKGROUND AND OBJECTIVE: Salmeterol and fluticasone propionate are well established in the treatment of childhood asthma, and their combination is effective in children aged 4-11 years. Asthma guidelines recommend that the inhaler device best suited to the individual should be used to administer asthma treatment. The aim of this study was to further evaluate the efficacy of salmeterol/fluticasone propionate combination (SFC) delivered by the Diskustrade mark (50/100mug, one inhalation twice daily) and compare it with that observed when SFC is delivered by a chlorofluorocarbon-free pressurised metered-dose inhaler (pMDI) [25/50mug, two inhalations twice daily] in children aged 4-11 years with persistent asthma. PATIENTS AND METHODS: This equivalence study had a multicentre, randomised, double-blind, double-dummy, parallel-group design and comprised asthmatic children aged 4-11 years who required beclometasone (beclomethasone dipropionate) </=500 mug/day (or equivalent). After a 2-week run-in using existing inhaled corticosteroid therapy, patients were randomised to receive SFC via Diskustrade mark (n = 213) or pMDI (n = 215, with 82% using a spacer) for 12 weeks. Salbutamol (Ventolin((R))) was provided for symptomatic relief. The primary endpoint was mean morning peak expiratory flow rate (PEF) recorded by patients during weeks 1-12. Secondary endpoints included other lung function parameters, day- and night-time symptoms, use of rescue medication and percentage of symptom- and salbutamol-free days. Adverse events and 12-hour overnight urinary cortisol concentrations were monitored to assess safety. RESULTS: Treatment with SFC, delivered by either device, was highly effective in improving patients' morning PEF and asthma symptoms. Over the whole study period, morning PEF (mean +/- standard error) improved by 37.7 +/- 3.1 L/min in the Diskustrade mark group and by 38.6 +/- 3.0 L/min in the pMDI group. The -0.9 L/min difference between groups (95% CI -7.1, 5.4) was within the predefined criterion for equivalence of (i.e. -15, 15 L/min). The median percentage of symptom-free and rescue medication-free days and nights increased considerably in both groups. For all efficacy parameters assessed, improvement occurred for all age groups as early as weeks 1-4, and was sustained over the 12 weeks. Both Diskustrade mark and pMDI treatments were well tolerated and their safety profiles were comparable. CONCLUSION: SFC delivered via Diskustrade mark or pMDI was shown to be highly effective in asthmatic children aged 4-11 years. Children as young as 4 years were able to use the Diskustrade mark and pMDI effectively. The combination is clinically equivalent when administered via either device in this patient population. This means that both Diskustrade mark and pMDI (+ spacer) are suitable for administration of SFC, which provides prescribers/users with a choice of device.

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