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Spirometry — a non-invasive test that shows how well the lungs are functioning — offers critical data in the diagnosis, monitoring, and response to treatment assessment of a range of diseases, including asthma and COPD. The traditional use of spirometry in clinical trials requires a clinical visit, which poses significant challenges in terms of painting a granular picture of disease change day to day and month to month. Mobile spirometry is intended to address some of these limitations, with recent studies in respiratory disease suggesting that remote technology-supported solutions may generate more clinically meaningful data and simpler patient paths to participate in clinical research. The recent research addresses the concern about comparability of clinic and remote data — a finding that could support increased adoption in clinical research programs.
Patient-centric research
Collecting spirometry data remotely is done with a combination of a Bluetooth-enabled, handheld spirometer and an accompanying smartphone app that enables data collection and streaming of test results to cloud-based systems, allowing for near real-time evaluation of results. This data collection technique is more convenient for patients and provides dense data that is more reflective of everyday patient life.
Researchers recently addressed multiple concerns pertaining to remote spirometry. The results published in Clinical and Translational Science (CTS) (1) demonstrated good patient compliance, high correlation, tight limits of agreement between mobile and clinic counterparts, and excellent test-retest reliability for both measures. Ensuring data quality when conducting pulmonary function testing (PFT) remotely is important. Factors that may influence data quality include physical exercise immediately prior to testing, body position, and movements during the test. Training and coaching should be made available for patients who conduct remote spirometry, similar to the training that would be provided to a patient conducting a PFT in the clinic. Both printed patient guides and app-based coaching can be utilized to help address these issues.
Covid-19 and the impact on clinical trials
Remote spirometry is becoming increasingly important during the COVID-19 pandemic for both care delivery and clinical trials. The American Thoracic Society (ATS) has urged healthcare professionals to keep clinic visits to an absolute minimum to reduce risk among vulnerable patients. Guidelines presented in November 2020 suggest that clinicians should use caution when determining if a clinic-based pulmonary function test should be utilized and that the risk of staff exposure to infection be considered relative to patient benefit. The ATS guidelines recommend, with some limitations, the use of at-home spirometry for patients who may require ongoing surveillance of pulmonary function.2
Utilizing digital biomarkers to gain new insights
Researchers have made significant adaptations to clinical trial conduct in response to the pandemic, including rapid increases in the adoption of remote and decentralized approaches.3 Remote spirometry is in line with these changes, with the added benefit of dense data collection that may be useful in understanding pulmonary function variation within a given patient, tracking disease progression and treatment response, thus enabling a more personalized medicine approach. Mobile spirometry offers patients and researchers a portable, connected tool with a high potential to improve data collection for clinical trials in respiratory conditions.
Learn more about Koneksa’s digital biomarker platform, including remote spirometry tools for clinical trials, at koneksahealth.com.
Footnotes:
1 Huang, C., Izmailova, E.S., Jackson, N., Ellis, R., Bhatia, G., Ruddy, M. and Singh, D. (2020), Remote FEV1 Monitoring in Asthma Patients: A Pilot Study. Clin Transl Sci. https://doi.org/10.1111/cts.12901
2 Wilson, K. C., Kaminsky, D. A., Michaud, G., Sharma, S., Nici, L., Folz, R. J., Barjaktarevic, I., Bhakta, N. R., Cheng, G., Chupp, G. L., Cole, A., Dixon, A. E., Finigan, J. H., Graham, B., Hallstrand, T. S., Haynes, J., Hankinson, J., MacIntyre, N., Mandel, J., McCarthy, K., … Powell, C. A. (2020). Restoring Pulmonary and Sleep Services as the COVID-19 Pandemic Lessens. From an Association of Pulmonary, Critical Care, and Sleep Division Directors and American Thoracic Society-coordinated Task Force. Annals of the American Thoracic Society, 17 (11), 1343–1351. https://doi.org/10.1513/AnnalsATS.202005-514ST
3 Izmailova ES, Ellis R, Benko C.Remote Monitoring in Clinical Trials During the COVID-19 Pandemic. Clin Transl Sci. 2020 Sep;13(5):838-841. doi: 10.1111/cts.12834. Epub 2020 Jul 8.