Smartphone─Mediated At-Home Telespirometry Erect and Supine Slow Vital Capacity Decline Differences Based On NIV Status in Subjects With ALS

Topic:

Clinical Trials

Poster Number: P274

Author(s):

Eufrosina I. Young, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Dongliang Wang, PhD, SUNY Upstate Medical University, Syracuse, New York, USA, George Slavinski, RRT, SUNY Upstate Medical University, Syracuse, New York, USA, Dragos Manta, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Birendra Sah, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Urvi Desai, MD, Atrium Health Neurosciences Institute, Charlotte, North Carolina, USA, Lena Deb, SUNY Upstate Medical University, Syracuse, New York, USA, Marielle Posmik, SUNY Upstate Medical University, Syracuse, New York, USA, Jeffrey Collins, RN, SUNY Upstate Medical University, Syracuse, New York, USA, Emma Blystone, SUNY Upstate Medical University, Syracuse, New York, USA, Jenny A. Meyer, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Bhavya Narapureddy, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Ahmed Ibrahim, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Grace Biso, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Darshana Vijaywargiya, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Sara Abdelhafiz, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Pradeep Chevula, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Takuya Kudo, MS, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan, Kinjal Patel, MHA, MBA, Mitsubishi Tanabe Pharma America, Inc., Jersey City, New Jersey, USA, Stephen Apple, MD, Mitsubishi Tanabe Pharma America, Inc., Jersey City, New Jersey, USA, Benjamin Rix Brooks, MD, Clinical Trials Planning LLC, Charlotte, North Carolina, USA

Background: At-home telespirometry (AHT) is being deployed to provide earlier treatment of amyotrophic lateral sclerosis (ALS)-associated respiratory comorbidities. This is the first implementation study to assess erect and supine slow vital capacity (eSVC/sSVC) longitudinally in subjects with ALS in the home between clinic visits.

Objectives: Measure eSVC/sSVC every two weeks via AHT in subjects with ALS between quarterly eSVC/sSVC assessments in a multicenter, prospective, longitudinal, observational clinical study [NCT05106569] with the ZEPHYRx® Remote Respiratory Monitoring™ dashboard and MIR’s Spirobank Smart Spirometer connected to the Breathe Easy application.

Results: eSVC/sSVC were measured via conventional spirometery during quarterly in-clinic assessments (baseline, 12, 24 weeks) and via AHT at two-week intervals in the home with respiratory therapist supervision for each subject/caregiver. Real-time respiratory data from subject’s smartphone was accessible on a dashboard for pulmonologist review and RedCap database download. Validity between conventional and portable spirometers and subject repeatability were completed. eSVC/sSVC change over time was analyzed with the random effects linear model. Subjects (n=98): age at ALS diagnosis (standard deviation [SD])=62.6 (10.4) years; disease duration (SD)=0.8 (1.8) years; ALSFRS-Rtotal (SD)=33.3 (7.6); eSVC baseline (SD)=72.6 (21.7) %predicted (%p); non-invasive ventilation (NIV)baseline=19; NIVstarted post-baseline=38; NIVnon-user=41. Most (72.5%) subjects completed ≥6 AHT. Monthly decline rate for eSVC (−1.75 %p/month, P<0.001) and sSVC (−1.12 %p/month, P<0.001) of NIV non-users was statistically significantly different from the monthly decline rate for eSVC (−3.10 %p/month) and sSVC (−3.31 %p/month) for subjects who started NIV after baseline. However, the monthly decline rate for eSVC (−1.25 %p/month) and sSVC (−1.00 %p/month) for subjects on NIV at baseline was not statistically different from NIV non-users. Conclusions: This first implementation study of smartphone application-mediated AHT eSVC/sSVC measurement suggest statistically significant differences in monthly decline between NIV non-users and subjects on NIV at baseline vs subjects who started NIV post-baseline. Further within-group analysis of the latter cohort of NIV adopters is ongoing to determine when monthly decline rate decreases with NIV initiation.