Background Maintenance and reliever therapy (MART) with inhaled corticosteroid (ICS)/formoterol effectively reduces exacerbations in asthma. We aimed to investigate its efficacy compared with fixed-dose fluticasone/salmeterol in chronic obstructive pulmonary disease (COPD). Methods Patients with COPD and ≥1 exacerbation in the previous 2 years were randomly assigned to open-label MART (Spiromax budesonide/formoterol 160/4.5 µg 2 inhalations twice daily+1 prn) or fixed-dose therapy (Diskus fluticasone propionate/salmeterol combination (FSC) 500/50 µg 1 inhalation twice daily+salbutamol 100 µg prn) for 1 year. The primary outcome was rate of moderate/severe exacerbations, defined by treatment with oral prednisolone and/or antibiotics. Results In total, 195 patients were randomised (MART Bud/Form n=103; fixed-dose FSC n=92). No significant difference was seen between MART and FSC therapy in exacerbation rates (1.32 vs 1.32 /year, respectively, rate ratio 1.05 (95% CI 0.79 to 1.39); p=0.741). No differences in lung function parameters or health status were observed. Total ICS dose was significantly lower with MART than FSC therapy (budesonide-equivalent 928 µg/day vs 1747 µg/day, respectively, p<0.05). Similar proportions of patients reported adverse events (MART Bud/Form: 73% vs fixed-dose FSC: 68%, p=0.408) and pneumonias (MART: 5% vs FSC: 1%, p=0.216). Conclusions This first study of MART in COPD found that budesonide/formoterol MART might be similarly effective to fluticasone/salmeterol fixed-dose therapy in moderate to severe patients with COPD, at a lower daily ICS dosage. Further evidence is needed about long-term safety. Data are available on reasonable request. Please contact the corresponding author in case of interest in potential data access.

中文翻译：

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COPD 患者布地奈德/福莫特罗维持和缓解治疗与氟替卡松/沙美特罗固定剂量治疗的比较

背景 使用吸入皮质类固醇 (ICS)/福莫特罗的维持和缓解疗法 (MART) 可有效减少哮喘的恶化。我们的目的是比较其与固定剂量氟替卡松/沙美特罗在慢性阻塞性肺疾病 (COPD) 中的疗效。方法 患有 COPD 且在过去 2 年内有 ≥ 1 次急性加重的患者被随机分配到开放标签 MART（Spiromax 布地奈德/福莫特罗 160/4.5 µg 2 次吸入，每天两次 + 1 prn）或固定剂量治疗（丙酸氟替卡松/沙美特罗组合） (FSC) 500/50 µg 1 次吸入，每天两次 + 沙丁胺醇 100 µg prn)，为期 1 年。主要结果是中度/重度恶化的发生率，定义为口服泼尼松龙和/或抗生素治疗。结果 总共有 195 名患者被随机分组​​（MART Bud/Form n=103；固定剂量 FSC n=92）。在恶化率方面，MART 和 FSC 治疗之间没有显着差异（分别为 1.32 对 1.32 / 年，比率为 1.05（95% CI 0.79 至 1.39）；p=0.741）。未观察到肺功能参数或健康状况的差异。MART 的总 ICS 剂量显着低于 FSC 治疗（布地奈德当量分别为 928 µg/天和 1747 µg/天，p<0.05）。相似比例的患者报告了不良事件（MART Bud/Form：73% vs 固定剂量 FSC：68%，p=0.408）和肺炎（MART：5% vs FSC：1%，p=0.216）。结论 这项针对 COPD 患者的 MART 研究发现，布地奈德/福莫特罗 MART 可能与氟替卡松/沙美特罗固定剂量治疗在中度至重度 COPD 患者中具有相似的疗效，但每日 ICS 剂量较低。需要关于长期安全性的进一步证据。可应合理要求提供数据。如果对潜在的数据访问感兴趣，请联系相应的作者。