Papi A, Paggiaro P, Nicolini G, Vignola A M, Fabbri L M
Research Centre on Asthma and COPD, University of Ferrara, Ferrara, Italy.
Allergy. 2007 Oct;62(10):1182-8. doi: 10.1111/j.1398-9995.2007.01493.x.
Recommended treatment for moderate to severe asthma is the combination of an inhaled corticosteroid and a long-acting beta(2)-agonist. The present study was designed to compare a new fixed combination of extrafine beclomethasone and formoterol, with the fixed combination fluticasone and salmeterol.
This was a phase III, multinational, multicentre, double-blind, randomized, two-arm parallel groups, controlled study. After a 2-week run-in period, 228 patients with moderate to severe asthma were randomized to a 12-week treatment with either beclomethasone 100 microg plus formoterol 6 microg or fluticasone 125 microg plus salmeterol 25 microg, both delivered two inhalations b.i.d. via a pressurized metered dose inhaler.
The analysis of noninferiority on the primary outcome, morning peak expiratory flow in the last 2 weeks of treatment, showed no difference between groups (difference -3.32 l/min; 95% CI -17.92 to 11.28). A significant improvement from baseline in lung function, symptom score and rescue medication use was observed in both groups at all time points. Beclomethasone plus formoterol combination showed a significantly faster onset of bronchodilation when compared with fluticasone plus salmeterol with the difference maintained for up to 1 h postdosing. No differences were observed between treatments in the rate of asthma exacerbations, frequency of adverse events and overnight urinary cortisol/creatinine ratio.
The new combination of extrafine beclomethasone plus formoterol is not inferior to the marketed combination of fluticasone and salmeterol in terms of efficacy and tolerability, with the advantage of a faster onset of bronchodilation. ( ClinicalTrials.gov number, NCT00394368).
中重度哮喘的推荐治疗方法是吸入性糖皮质激素与长效β₂受体激动剂联合使用。本研究旨在比较布地奈德超细粉与福莫特罗的新型固定复方制剂与氟替卡松和沙美特罗的固定复方制剂。
这是一项III期、多国、多中心、双盲、随机、双臂平行组对照研究。经过2周的导入期后，228例中重度哮喘患者被随机分为两组，分别接受为期12周的治疗，一组使用100微克布地奈德加6微克福莫特罗，另一组使用125微克氟替卡松加25微克沙美特罗，均通过压力定量吸入器每日两次，每次两喷给药。
对主要结局指标（治疗最后2周的早晨呼气峰流速）的非劣效性分析显示，两组之间无差异（差值为-3.32升/分钟；95%置信区间为-17.92至11.28）。在所有时间点，两组的肺功能、症状评分和急救药物使用情况与基线相比均有显著改善。与氟替卡松加沙美特罗相比，布地奈德加福莫特罗组合的支气管扩张起效明显更快，给药后这种差异持续长达1小时。在哮喘加重率、不良事件发生率和夜间尿皮质醇/肌酐比值方面，各治疗组之间未观察到差异。
布地奈德超细粉加福莫特罗的新型复方制剂在疗效和耐受性方面不劣于市售的氟替卡松和沙美特罗复方制剂，且具有支气管扩张起效更快的优势。（ClinicalTrials.gov编号，NCT00394368）
