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Forced Expiratory Flow (FEF 25–75% ) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis

机译:强迫呼气流(FEF 25-75%)作为儿童和青少年的临床终点,具有症状哮喘接受噻托基:后HOC分析

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IntroductionIn pediatric patients with asthma, measurements of forced expiratory volume in 1?s (FEVsub1/sub) may be normal or may not correlate with symptom severity. Forced expiratory flow at 25–75% of the vital capacity (FEFsub25–75%/sub) is a potentially more sensitive parameter for assessing peripheral airway function. This post hoc analysis compared FEFsub25–75%/sub with FEVsub1/sub as an endpoint to assess bronchodilator responsiveness in children with asthma.MethodsChange from baseline in trough FEFsub25–75%/sub and trough FEVsub1/sub following treatment with either tiotropium (5?μg or 2.5?μg) or placebo Respimatsup?/sup was analyzed in four phase III trials in children (aged 6–11?years) and adolescents (aged 12–17?years) with symptomatic moderate (VivaTinA-asthmasup?/sup and PensieTinA-asthmasup?/sup) and mild (CanoTinA-asthmasup?/sup and RubaTinA-asthmasup?/sup) asthma. Data from all treatment arms were pooled and correlations between FEFsub25–75%/sub and FEVsub1/sub were calculated and analyzed.ResultsA total of 1590 patients were included in the analysis. Tiotropium Respimatsup?/sup consistently improved FEFsub25–75%/sub and FEVsub1/sub versus placebo, although in adolescents with severe asthma, the observed improvements were not statistically significant. Improvements in FEFsub25–75%/sub response with tiotropium versus placebo were largely more pronounced than improvements in FEVsub1/sub. Statistical assessment of the correlation of FEVsub1/sub and FEFsub25–75%/sub showed moderate-to-high correlations (Pearson’s correlation coefficients 0.73–0.80).ConclusionsIn pediatric patients, FEFsub25–75%/sub may be a more sensitive measure to detect treatment response, certainly to tiotropium, than FEVsub1/sub and should be evaluated as an additional lung function measurement.
机译:引入哮喘的儿科患者,1?S(FEV 1 )中强制呼气量的测量可能是正常的,也可能与症状严重程度相关。强制呼气流量为25-75%的生命能力(FEF 25-75%)是评估外围气道功能的可能更敏感的参数。该后HOC分析与FEV 1 作为终点将FEF 25-75%与哮喘的儿童评估过度胆管响应性的终点。从槽Fef中的基线 25-在四阶段III试验中分析了在四阶段III试验中进行后处理后75%的和槽10℃ 1 在4阶段III试验中进行分析儿童(6-11岁?岁月)和青少年(12-17岁?年龄)症状中等(vivatina-anthma ?和pensietina-anthma ?)和轻度( Canotina-anthma β-β-哮喘β-β-β-腹泻。汇集来自所有处理臂的数据,CEF 25-75%和fev 1 一致改善Fef 25-75%和fev 1 与安慰剂,尽管在具有严重哮喘的青少年中,观察到的改进没有统计学重大。 FEF 25-75%响应的改善与噻托米与安慰剂的响应在很大程度上比FEV 1 的改进更明显。对FEV 1 和fef 25-75%的相关性的统计评估显示了中度至高的相关性(Pearson的相关系数0.73-0.80).Conclusionsin儿科患者,FEF <亚> 25-75%可以是更敏感的措施,以检测对脱毒水中的治疗响应,而不是FEV 1 ,并且应该被评估为额外的肺功能测量。

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