Introduction. Many patients with chronic obstructive pulmonary disease (COPD) may derive inadequate benefit from dry powder inhalers (DPIs) because of suboptimal peak inspiratory flow (sPIF). Objectives. To assess the clinical burden of COPD by characterizing the clinical characteristics of participants with sPIF against medium-low resistance DPIs versus those with optimal PIF (oPIF) from two phase 3 clinical trials. Methods. Baseline data were collected from two randomized, controlled, phase 3 trials (NCT03095456; NCT02518139) in participants with moderate-to-severe COPD. oPIF (60 L/min) against the medium-low resistance DPIs was used as the threshold for defining the PIF subgroups (<60 L/min (sPIF) vs ≥60 L/min (oPIF)). Results. Most participants included in this analysis were White (92%) and male (63%); the mean (range) age was 65 (43–87) years. Participants with sPIF had significantly greater dyspnea than those with oPIF as measured using the modified Medical Research Council scoring (mean (95% CI): 2.1 (2.0–2.2) vs 1.6 (1.4–1.7); ) and baseline dyspnea index (mean (95% CI): 5.1 (4.9–5.4) vs 6.1 (5.8–6.3); ). Based on COPD Assessment Test scores, participants with sPIF had a higher COPD symptom burden than those with oPIF (mean (95% CI): 21.5 (19.7–23.3) vs 19.5 (18.6–20.4); 5). Conclusion. In these trials, participants with COPD who had sPIF against the medium-low resistance DPIs had more dyspnea and worse health status than those with oPIF. These results demonstrate that sPIF is associated with a higher clinical burden as measured by patient-reported outcomes.

中文翻译：

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吸气峰流速不理想的慢性阻塞性肺疾病患者的临床负担

介绍。由于吸气峰值流量 (sPIF) 不理想，许多慢性阻塞性肺疾病 (COPD) 患者可能无法从干粉吸入器 (DPI) 中获益。目标。通过描述两项 3 期临床试验中 sPIF 与中低耐药 DPI 参与者与最佳 PIF (oPIF) 参与者的临床特征，评估 COPD 的临床负担。方法。基线数据来自两项随机对照 3 期试验（NCT03095456；NCT02518139），受试者为中重度慢性阻塞性肺病患者。 oPIF (60 L/min) 与中低阻力 DPI 的比较被用作定义 PIF 亚组的阈值（<60 L/min (sPIF) 与 ≥60 L/min (oPIF)）。结果。本次分析中的大多数参与者是白人 (92%) 和男性 (63%)；平均（范围）年龄为 65（43-87）岁。根据修改后的医学研究委员会评分进行测量，sPIF 参与者的呼吸困难程度明显高于 oPIF 参与者（平均值 (95% CI)：2.1 (2.0–2.2) vs 1.6 (1.4–1.7)；)和基线呼吸困难指数（平均值 (95% CI)：5.1 (4.9–5.4) vs 6.1 (5.8–6.3)；）。根据 COPD 评估测试分数，sPIF 参与者比 oPIF 参与者有更高的 COPD 症状负担（平均值 (95% CI)：21.5 (19.7–23.3) vs 19.5 (18.6–20.4)；5）。结论。在这些试验中，使用 sPIF 对抗中低阻力 DPI 的 COPD 参与者比使用 oPIF 的参与者有更多的呼吸困难和更差的健康状况。这些结果表明，根据患者报告的结果衡量，sPIF 与较高的临床负担相关。