Background Despite currently available standard-of-care inhaled corticosteroid (ICS)/long-acting β2-agonist therapies, a substantial proportion of patients with asthma remain inadequately controlled. This pooled analysis evaluated efficacy and safety of mometasone furoate/indacaterol acetate (MF/IND) versus fluticasone propionate/salmeterol xinafoate (FLU/SAL) in patients with inadequately controlled asthma. Methods This analysis included patients from PALLADIUM ([NCT02554786][1]) and IRIDIUM ([NCT02571777][2]) studies who received high-dose MF/IND (320/150 µg) or medium-dose MF/IND (160/150 µg) one time a day or high-dose FLU/SAL (500/50 µg) two times a day for 52 weeks. Reduction in asthma exacerbations, improvement in lung function, asthma control, and safety were evaluated for 52 weeks. Results In total, 3154 patients (high-dose MF/IND, n=1054; medium-dose MF/IND, n=1044; high-dose FLU/SAL, n=1056) were included. High-dose MF/IND showed 26%, 22% and 19% reductions in rate of severe, moderate or severe, and all (mild, moderate and severe) exacerbations versus high-dose FLU/SAL, respectively, over 52 weeks (all, p<0.05). High-dose MF/IND improved trough FEV1 versus high-dose FLU/SAL at weeks 26 (Δ, 43 mL, p=0.001) and 52 (Δ, 51 mL, p<0.001). Reductions in asthma exacerbation rate and improvement in trough FEV1 with medium-dose MF/IND were comparable with high-dose FLU/SAL over 52 weeks. All treatments improved Asthma Control Questionnaire-7 score from baseline to 52 weeks with no difference between treatments. Safety was comparable between high-dose MF/IND and high-dose FLU/SAL. Conclusions One time a day, single-inhaler, high-dose MF/IND reduced asthma exacerbations and improved lung function versus two times a day, high-dose FLU/SAL in patients with inadequately controlled asthma. Similarly, improved outcomes were seen with one time a day, medium-dose MF/IND and two times a day, high-dose FLU/SAL, but at a lower ICS dose. Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. Novartis is committed to sharing access to patient-level data and supporting documents from eligible studies with qualified external researchers. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided are anonymised to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02554786&atom=%2Fbmjresp%2F8%2F1%2Fe000819.atom [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02571777&atom=%2Fbmjresp%2F8%2F1%2Fe000819.atom

中文翻译：

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每日一次莫米松/茚达特罗固定剂量联合用药对比每日两次氟替卡松/沙美特罗对哮喘控制不佳患者的疗效：PALLADIUM 和 IRIDIUM 研究的汇总分析

背景 尽管目前可获得标准的吸入性皮质类固醇 (ICS)/长效 β2 受体激动剂疗法，但仍有相当大比例的哮喘患者未得到充分控制。这项汇总分析评估了糠酸莫米松/醋酸茚达特罗 (MF/IND) 与丙酸氟替卡松/昔萘酸沙美特罗 (FLU/SAL) 在哮喘控制不佳患者中的疗效和安全性。方法 该分析包括接受高剂量 MF/IND (320/150 µg) 或中剂量 MF/IND (160/ 150 µg) 一天一次或大剂量 FLU/SAL (500/50 µg) 一天两次，持续 52 周。对哮喘发作的减少、肺功能的改善、哮喘的控制和安全性进行了 52 周的评估。结果 总共有 3154 名患者（高剂量 MF/IND，n=1054；中等剂量 MF/IND，n=1044；包括高剂量 FLU/SAL，n=1056）。与高剂量 FLU/SAL 相比，高剂量 MF/IND 在 52 周内（所有, p < 0.05)。在第 26 周（Δ，43 mL，p=0.001）和第 52 周（Δ，51 mL，p<0.001），高剂量 MF/IND 与高剂量 FLU/SAL 相比改善了谷 FEV1。在 52 周内，中等剂量 MF/IND 降低哮喘发作率和改善 FEV1 谷值与高剂量 FLU/SAL 相当。所有治疗均将哮喘控制问卷 7 评分从基线提高到 52 周，治疗之间没有差异。高剂量 MF/IND 和高剂量 FLU/SAL 的安全性相当。结论 一天一次，单次吸入，与一天两次的高剂量 FLU/SAL 相比，高剂量 MF/IND 在哮喘控制不佳的患者中减少了哮喘发作并改善了肺功能。同样，每天一次，中等剂量 MF/IND 和每天两次，高剂量 FLU/SAL，但在较低的 ICS 剂量下，可以看到改善的结果。可根据合理要求提供数据。所有与研究相关的数据都包含在文章中或作为补充信息上传。诺华致力于与合格的外部研究人员共享对符合条件的研究的患者级数据和支持文件的访问。这些请求由独立审查小组根据科学价值进行审查和批准。提供的所有数据都是匿名的，以尊重参与试验的患者的隐私，符合适用的法律和法规。[1]：