Remote Spirometry Insights
Interest in virtual trials and remote spirometry greatly increased with the COVID-19 pandemic. As subjects were less able to attend in-clinic visits due to stay-at-home orders and concerns about spread of the disease, the need for in-home spirometry increased. As some pandemic-related restrictions are being eased, we explore the role of remote spirometry going forward.
Promise of Remote Spirometry
The technology to collect spirometry at a clinical trial patient’s home is now routinely available and shows promise to allow FEV1 maneuvers to be effectively and reliably collected without clinical visits. Home monitoring programs with wireless remote spirometry using a patient’s home wi-fi network and Bluetooth devices are compact and affordable, allowing a patient to comfortably collect spirometry without the burden of travel to the clinic for routine monitoring of FEV1.
Recent pilot studies by C.C Moor 1, Huang2, and Masa 3 have shown that the FVC and FEV1 values collected in the patient’s home strongly correlate to the value completed in the clinic. Patients’ compliance was high when collecting spirometry in their homes, and patients were more engaged in monitoring their spirometry values.
Remote Spirometry Advantages:
- The technology to collect spirometry at a clinical trial patient’s home is now routinely available
- Remote spirometry devices are compact and affordable
- Patients’ compliance may be higher when collecting spirometry in their homes
- Patients may be more engaged in monitoring their spirometry values at home
Limitations of Remote Spirometry
When considering possible limitations of remote spirometry, it is helpful to bear in mind the purpose of spirometry as a tool used to determine the function of the lung. Spirometry allows classification of normal or impaired states such as obstructive, in COPD, or restrictive processes as with interstitial lung disease. While the procedure itself is not complex, there are technical aspects to consider while performing or collecting spirometry that could present challenges to conducting remote spirometry.
Remote Spirometry Drawbacks:
- Spirometry is effort dependent. Without a qualified person coaching the subject, then the FVC maneuver may be underperformed.
- Use of the equipment. Patient may not understand how to, or be able to, use the spirometer without assistance.
- Collection of acceptability and repeatable spirometry maneuvers. Acceptance of low-quality efforts by the patient will give inaccurate readings.
- Meeting ATS/ERS standards. Under the ATS/ERS 2005 standards, subjects must have a six second forced expiratory time for acceptable FEV1.4 ATS/ERS 2019 standards have updated the acceptability criteria regarding expiratory time to greater than or equal to 15 seconds.5 Some patients would have difficulty meeting standards even with built-in software prompts.
Returning to the Clinic
While remote spirometry offers great promise for monitoring subject safety and compliance, spirometry testing as a primary endpoint will most likely eventually return to the clinic for drug trials. There are still concerning inconsistencies when it comes to fully completing and collecting spirometry values in the home. A hybrid approach may be adopted as the industry waits for the technology and the human factor to be improved upon.
Future Role for Remote Spirometry
Until a more reliable way to standardize and reduce the variability in home spirometry becomes available, spirometry for clinical trial primary end points will continue to be collected in clinic. However, there is a place for more routine monitoring of clinical trial patients with remote monitoring, such as safety or diary compliance, FEV1 measurement for disease state assessment, or other study endpoints.
1. Moor, C.C., Wapenaar, M., Miedema, J.R. et al. A home monitoring program including real-time wireless home spirometry in idiopathic pulmonary fibrosis: a pilot study on experiences and barriers. Respir Res 19, 105 (2018). https://doi.org/10.1186/s12931-018-0810-3
2. Huang, C., Izmailova, E.S., Jackson, N., Ellis, R., Bhatia, G., Ruddy, M. and Singh, D. (2021), Remote FEV1 monitoring in asthma patients: A Pilot Study. Clin Transl Sci, 14: 529-535. https://doi.org/10.1111/cts.12901
3. J.F. Masa, M.T. González, R. Pereira, M. Mota, J.A. Riesco, J. Corral, J. Zamorano, M. Rubio, J. Teran, R. Farré. Validity of spirometry performed on-line. European Respiratory Journal Apr 2011, 37 (4) 911-918; DOI: 10.1183/09031936.00011510
4. Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, et al.; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J 2005;26:319-338.
5. Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST. PMID: 31613151; PMCID: PMC6794117.