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Clinical Trial
. 2023 Nov;164(5):1087-1096.
doi: 10.1016/j.chest.2023.06.029. Epub 2023 Jun 27.

Clinic vs Home Spirometry for Monitoring Lung Function in Patients With Asthma

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
Affiliations
Free article
Clinical Trial

Clinic vs Home Spirometry for Monitoring Lung Function in Patients With Asthma

John Oppenheimer et al. Chest. 2023 Nov.
Free article

Abstract

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.

Keywords: asthma; pulmonary function test; spirometry.

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Conflict of interest statement

Financial/Nonfinancial Disclosures The authors have reported to CHEST the following: Z. B., E. P., and D. S. are employees of GSK, and own stocks or shares in GSK. A. F. was an employee of GSK at the time of the studies and owns stocks or shares in GSK, and is currently an employee of AstraZeneca. G. P. is an employee of GSK and holds stocks or shares in GSK and Novartis. R. C. has received lecture fees from AstraZeneca, Chiesi, GSK, Novartis, Sanofi, and Teva; honoraria for advisory board meetings from AstraZeneca, Chiesi, GSK, Novartis, and Teva; sponsorship to attend international scientific meetings from AstraZeneca, GSK, Boehringer, Chiesi, Napp, and Sanofi; and a research grant from AstraZeneca. N. A. H. reports personal fees from Amgen, AstraZeneca, Boehringer Ingelheim, Genentech, GSK, Mylan, Novartis, Regeneron, Sanofi Genzyme, and Teva, and for serving as an advisor or consultant. He also received research support from AstraZeneca, Boehringer Ingelheim, Genentech, Gossamer Bio, GSK, Novartis, and Sanofi Genzyme. J. O. has served on adjudication committees or data and safety monitoring boards for AstraZeneca, GSK, Novartis, and Sanofi/Regeneron, and has received grants and personal fees from GSK. H. S. has received lecture fees from AstraZeneca, GSK, Novartis, and Sanofi.

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