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The recommendations, according to international guidelines, for moderate asthma poorly controlled by inhaled corticosteroid therapy (800 to 1000 μg/day) — Step Three asthma — is a combination treatment strategy consisting of a longacting bronchodilator plus an inhaled corticosteroid. This comparative multicentre, randomised, open, parallel-group study was designed to compare salmeterol (50μg twice daily) + beclomethasone dipropionate (BDP) [500μg twice daily] (both administered via metered dose inhaler) with slow-release (SR) terbutaline (5mg twice daily) + budesonide (BUD) [400μg twice daily] (administered via tablet and dry powder inhaler, respectively) for the treatment of Step Three asthma. The effects of the two combination regimens were assessed using lung function measurements, asthma symptoms, frequency of use of rescue β2-agonist, overall efficacy, quality of life and tolerability. After a 2-week run-in period, 98 patients were randomised to receive salmeterol/BDP and 96 to receive SR-terbutaline/BUD for 8 weeks. Both treatment arms significantly improved all of the above parameters. However, the improvements observed in the salmeterol/BDP group were significantly better than those in the SR-terbutaline/BUD group for the following parameters: increase in spirometric and homemonitored peak expiratory flow (PEF), reduction in diurnal variation of PEF, reduction in use of daytime salbutamol as rescue medication, patients’ and investigators’ assessment of efficacy, and improvement in quality-of-life score using the Qualite de Vie Subjective de l’Asthmatique questionnaire. Both drug combinations were well tolerated, with slightly fewer patients experiencing treatmentrelated adverse events in the salmeterol/BDP group (9 vs 14%). In conclusion, whilst both combination regimens achieved the goals set out in the management of asthma guidelines for Step Three asthma, greater control of asthma was observed using the salmeterol/BDP combination in this asthmatic patient population. |
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