CAPTAIN 研究中中度和重度哮喘加重的特征描述
2024/09/29
摘要
背景：有关中度和重度哮喘加重对哮喘控制和损伤的相对影响的数据有限。
目的：探索 CAPTAIN 试验的数据，评估首次中度或重度病情加重与肺功能、症状、体力活动限制评分和短效β2-激动剂（SABA）使用量变化之间的关系，以确定中度病情加重的临床意义。
方法：CAPTAIN是一项为期24- 52周的IIIA期、多中心、国际随机对照试验，评估糠酸氟替卡松/乌莫替尼/维兰特罗(FF/UMEC/VI)与FF/VI在吸入皮质类固醇/长效β2激动剂治疗的未控制哮喘患者中的疗效和安全性。报告的结局包括按严重程度划分的首次随机化后加重事件(第1-52周)、中度和重度加重的频率和持续时间，以及在±14天的加重期内肺功能、症状、局限性和SABA使用的变化时间过程。
结果：在意向治疗人群（2436人）中，有550名患者（23%）继续治疗52周。中度和重度病情恶化分别为529例和546例。肺功能变化相似，但与中度加重相比，重度加重症状、体力活动受限评分和SABA使用量更高。肺功能下降先于症状、体力活动受限评分和 SABA 使用量的增加，而与病情加重的严重程度无关。无论病情严重与否，肺功能变量、活动受限评分和 SABA 使用量均在大约8到12天后恢复到病情恶化前的基线。
结论：虽然严重事件对症状、体力活动限制和SABA使用的影响更大，但中度和严重事件的发病和缓解时间基本相似。这两种严重程度的病情加重都代表着具有重要临床意义的病情恶化，包括临床和功能上的变化。
Characterization of Moderate and Severe Asthma Exacerbations in the CAPTAIN Study
Oppenheimer, John; Kerstjens, Huib A; Boulet, Louis-Philippe; Hanania, Nicola A; Kerwin, Edward; Moore, Alison; Nathan, Robert A; Peachey, Guy; Pizzichini, Emilio; Slade, David; Zarankaite, Agne; Pavord, Ian D
Abstract
BACKGROUND:Limited data exist on the relative impact of moderate and severe exacerbations on asthma control and impairment.
OBJECTIVE: To explore data from the CAPTAIN trial to evaluate the relationship between first moderate or severe exacerbation and changes in lung function, symptoms, physical activity limitation scores, and short-acting beta2-agonist (SABA) usage to determine the clinical relevance of moderate events.
METHODS: CAPTAIN was a phase IIIA 24- to 52-week, multicenter, international, randomized controlled trial evaluating efficacy and safety of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI in patients with uncontrolled asthma on inhaled corticosteroid/long-acting beta2-agonist. Outcomes reported include first postrandomization exacerbation event by severity (wk 1-52), frequency and duration of moderate and severe exacerbations, and time course of changes over ± 14-day peri-exacerbation period for lung function, symptoms, limitations, and SABA use.
RESULTS: Of the intent-to-treat population (n= 2,436), 550 patients (23%) continued to 52 weeks. There were 529 moderate and 546 severe exacerbations. Lung function changes were similar, but symptom, physical activity limitation scores, and SABA use were higher, for severe versus moderate exacerbations. Lung function decline preceded increases in symptom, physical activity limitation scores, and SABA use, irrespective of exacerbation severity. Lung function variables, limitation scores, and SABA use returned to pre-exacerbation baseline after approximately 8 to 12 days for both exacerbation severities.
CONCLUSIONS: Whereas severe events were associated with greater impact on symptoms, physical activity limitations, and SABA use, onset and time to resolution were generally similar for moderate and severe events. Both exacerbation severities represent clinically important deteriorations comprising clinical and functional changes.
背景：有关中度和重度哮喘加重对哮喘控制和损伤的相对影响的数据有限。
目的：探索 CAPTAIN 试验的数据，评估首次中度或重度病情加重与肺功能、症状、体力活动限制评分和短效β2-激动剂（SABA）使用量变化之间的关系，以确定中度病情加重的临床意义。
方法：CAPTAIN是一项为期24- 52周的IIIA期、多中心、国际随机对照试验，评估糠酸氟替卡松/乌莫替尼/维兰特罗(FF/UMEC/VI)与FF/VI在吸入皮质类固醇/长效β2激动剂治疗的未控制哮喘患者中的疗效和安全性。报告的结局包括按严重程度划分的首次随机化后加重事件(第1-52周)、中度和重度加重的频率和持续时间，以及在±14天的加重期内肺功能、症状、局限性和SABA使用的变化时间过程。
结果：在意向治疗人群（2436人）中，有550名患者（23%）继续治疗52周。中度和重度病情恶化分别为529例和546例。肺功能变化相似，但与中度加重相比，重度加重症状、体力活动受限评分和SABA使用量更高。肺功能下降先于症状、体力活动受限评分和 SABA 使用量的增加，而与病情加重的严重程度无关。无论病情严重与否，肺功能变量、活动受限评分和 SABA 使用量均在大约8到12天后恢复到病情恶化前的基线。
结论：虽然严重事件对症状、体力活动限制和SABA使用的影响更大，但中度和严重事件的发病和缓解时间基本相似。这两种严重程度的病情加重都代表着具有重要临床意义的病情恶化，包括临床和功能上的变化。
（中日友好医院呼吸与危重症医学科 李春晓 摘译 林江涛 审校）
（J Allergy Clin Immunol Pract. 2024 Sep;12(9):2372-2380.e5.DOI10.1016/j.jaip.2024.05.019）
（J Allergy Clin Immunol Pract. 2024 Sep;12(9):2372-2380.e5.DOI10.1016/j.jaip.2024.05.019）
Characterization of Moderate and Severe Asthma Exacerbations in the CAPTAIN Study
Oppenheimer, John; Kerstjens, Huib A; Boulet, Louis-Philippe; Hanania, Nicola A; Kerwin, Edward; Moore, Alison; Nathan, Robert A; Peachey, Guy; Pizzichini, Emilio; Slade, David; Zarankaite, Agne; Pavord, Ian D
Abstract
BACKGROUND:Limited data exist on the relative impact of moderate and severe exacerbations on asthma control and impairment.
OBJECTIVE: To explore data from the CAPTAIN trial to evaluate the relationship between first moderate or severe exacerbation and changes in lung function, symptoms, physical activity limitation scores, and short-acting beta2-agonist (SABA) usage to determine the clinical relevance of moderate events.
METHODS: CAPTAIN was a phase IIIA 24- to 52-week, multicenter, international, randomized controlled trial evaluating efficacy and safety of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI in patients with uncontrolled asthma on inhaled corticosteroid/long-acting beta2-agonist. Outcomes reported include first postrandomization exacerbation event by severity (wk 1-52), frequency and duration of moderate and severe exacerbations, and time course of changes over ± 14-day peri-exacerbation period for lung function, symptoms, limitations, and SABA use.
RESULTS: Of the intent-to-treat population (n= 2,436), 550 patients (23%) continued to 52 weeks. There were 529 moderate and 546 severe exacerbations. Lung function changes were similar, but symptom, physical activity limitation scores, and SABA use were higher, for severe versus moderate exacerbations. Lung function decline preceded increases in symptom, physical activity limitation scores, and SABA use, irrespective of exacerbation severity. Lung function variables, limitation scores, and SABA use returned to pre-exacerbation baseline after approximately 8 to 12 days for both exacerbation severities.
CONCLUSIONS: Whereas severe events were associated with greater impact on symptoms, physical activity limitations, and SABA use, onset and time to resolution were generally similar for moderate and severe events. Both exacerbation severities represent clinically important deteriorations comprising clinical and functional changes.
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