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Clinic vs Home Spirometry for Monitoring Lung Function in Patients With Asthma
Chest ( IF 9.5 ) Pub Date : 2023-06-27 , DOI: 10.1016/j.chest.2023.06.029
John Oppenheimer 1 , Nicola A Hanania 2 , Rekha Chaudhuri 3 , Hironori Sagara 4 , Zelie Bailes 5 , Andrew Fowler 5 , Guy Peachey 5 , Emilio Pizzichini 6 , David Slade 7
Affiliation  

Background

Studies examining agreement between home and clinic spirometry in patients with asthma are limited, with conflicting results. Understanding the strengths and limitations of telehealth and home spirometry is particularly important considering the SARS-CoV-2 pandemic.

Research Question

How well do home and clinic measurements of trough FEV1 agree in patients with uncontrolled asthma?

Study Design and Methods

This post hoc analysis used trough FEV1 data from the randomized double-anonymized parallel-group phase 3A CAPTAIN (205715; NCT02924688) and phase 2B 205832 (NCT03012061) trials in patients with uncontrolled asthma. CAPTAIN evaluated the impact of adding umeclidinium to fluticasone furoate/vilanterol via a single inhaler; the 205832 trial investigated adding umeclidinium to fluticasone furoate vs placebo. Trough FEV1 measurements were collected via home spirometry and supervised in-person spirometry in the research clinic. To compare home and clinic spirometry, we examined the time-course analyses of home and clinic trough FEV1, and generated post hoc Bland-Altman plots to assess agreement between home and clinic spirometry.

Results

Data from 2,436 patients (CAPTAIN trial) and 421 patients (205832 trial) were analyzed. Treatment-related improvements in FEV1 were observed in both trials, using home and clinic spirometry. Improvements measured by home spirometry were of lower magnitude and less consistent than clinic measurements. Bland-Altman plots suggested poor agreement between home and clinic trough FEV1 at baseline and week 24.

Interpretation

This post hoc comparison of home and clinic spirometry is the largest conducted in asthma. Results showed that home spirometry was less consistent than and lacked agreement with clinic spirometry, suggesting that unsupervised home readings are not interchangeable with clinic measurements. However, these findings may only be applicable to home spirometry using the specific device and coaching methods employed in these studies. Postpandemic, further research to optimize home spirometry use is needed.

Clinical Trial Registration

ClinicalTrials.gov; Nos.: NCT03012061 and NCT02924688; URL: www.clinicaltrials.gov



中文翻译:

诊所与家庭肺活量测定法监测哮喘患者的肺功能

背景

检验哮喘患者家庭肺活量测定法与诊所肺活量测定法之间一致性的研究有限,且结果相互矛盾。考虑到 SARS-CoV-2 大流行,了解远程医疗和家庭肺活量测定的优点和局限性尤为重要。

研究问题

对于未受控制的哮喘患者,家庭和诊所测量的 FEV 1谷值的一致性如何?

研究设计和方法

这项事后分析使用了来自未受控制哮喘患者的随机双匿名平行组 3A 期 CAPTAIN (205715; NCT02924688) 和 2B 期 205832 (NCT03012061) 试验的FEV 1谷值数据。CAPTAIN 评估了通过单一吸入器向糠酸氟替卡松/维兰特罗添加芜地铵的影响;205832 试验研究了在糠酸氟替卡松中添加 Umeclidinium 与安慰剂的对比。通过家庭肺活量测定法和研究诊所监督的现场肺活量测定法收集谷值 FEV 1测量值。为了比较家庭和诊所肺量测定法,我们检查了家庭和诊所 FEV 1谷值的时程分析,并生成事后 Bland-Altman 图来评估家庭和诊所肺量测定法之间的一致性。

结果

分析了 2,436 名患者(CAPTAIN 试验)和 421 名患者(205832 试验)的数据。两项试验均使用家庭和诊所肺活量测定法观察到与治疗相关的FEV1改善。与临床测量相比,家庭肺活量测定法测量的改善程​​度较低且一致性较差。Bland-Altman 图表明家庭和诊所在基线和第 24 周的 FEV 1谷值之间的一致性较差。

解释

这项家庭和诊所肺活量测定法的事后比较是在哮喘领域进行的最大规模的比较。结果显示,家庭肺量测定法与诊所肺量测定法的一致性较差且缺乏一致性,这表明无人监督的家庭读数不能与诊所测量值互换。然而,这些发现可能仅适用于使用这些研究中使用的特定设备和指导方法的家庭肺活量测定。大流行后,需要进一步研究以优化家庭肺活量测定法的使用。

临床试验注册

临床试验.gov;编号:NCT03012061 和 NCT02924688;网址:www.clinicaltrials.gov

更新日期:2023-06-27
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