Internet-Supervised Home-Based Spirometry Through Telemedicine in Amyotrophic Lateral Sclerosis

Topic:

Clinical Trials

Poster Number: V197

Author(s):

Eufrosina Young, MD, SUNY Upstate Medical University, Dongliang Wang, PhD, SUNY Upstate Medical University, Dragos Manta, MD, SUNY Upstate Medical University, Birendra Sah, MD, SUNY Upstate Medical University, Urvi Desai, MD, Atrium Health Neurosciences Institute, Lena Deb, SUNY Upstate Medical University, Marielle Posmik, SUNY Upstate Medical University, Takuya Kudo, MS, Mitsubishi Tanabe Pharma Corporation, Kinjal Patel, MHA, MBA, Mitsubishi Tanabe Pharma America, Inc., Stephen Apple, MD, Mitsubishi Tanabe Pharma America, Inc., Benjamin Rix Brooks, MD, Atrium Health Neurosciences Institute; Clinical Trials Planning LLC

Background: A Pilot Implementation study of At-Home Telespirometry (AHT) measurement of erect-seated forced vital capacity (eFVC) suggested positive results in precision (Bland-Altman), repeatability, feasibility of longitudinal measurement, increased assessment of supine forced vital capacity (sFVC) in home situation and differential rate of loss of eFVC as function of initial eFVC at baseline. Slope measurements of eFVC change differ by stratification of initial eFVC at baseline in parallel with increased rate of eFVC loss and increased rate of number of eFVC 3% predicted monthly drops in cohort with eFVC <60% predicted at baseline.

Objectives: A total of 100 participants with amyotrophic lateral sclerosis (ALS) from two ALS Association-certified ALS clinics in the US (SUNY Upstate, Atrium Health) will be recruited to measure eFVC and sSVC erect-seated from home using a portable spirometer (MIR, Italy), ZEPHYRx software application (BreathEasy), and ZEPHYRx Provider Dashboard, over 6 months.

Results: Clinical and statistical analysis will follow the same procedure as the previous pilot FVC study. Cohorts stratified according to <60%, 60-80% and >80% predicted (%p) eSVC at baseline will be followed longitudinally to define eSVC and sSVC changes between canonical quarterly (q3month) in-clinic visits to assess whether clinically significant changes in eSVC and sSVC identify respiratory complications requiring initiation of ventilator support before the next in-clinic visit.

This prospective study [NCT05106569] has nearly completed recruitment of 100 participants with ALS. Baseline characteristics of enrolled participants with ALS will be similar to participants with ALS completing the pilot FVC study. An interim analysis of the first 50 participants to complete the study will be presented.

Conclusions: Stratification of eSVC obtained from baseline in-clinic measurement is predictive of ALS disease trajectory. This ongoing clinical study, using AHT to measure eSVC and sSVC between canonical in-clinic visits at home, aims to identify clinically significant, between clinic visit eSVC and sSVC changes, that may require earlier respiratory management than would occur from quarterly in-clinic visits.

Sponsorship: This study was sponsored by Mitsubishi Tanabe Pharma America, Inc.