Home spirometry in clinical trials: Evaluating adherence and quality in patients with asthma
Introduction: Home spirometry shows potential in respiratory clinical trials, as part of a decentralized strategy and because of the possibility to collect additional insights on treatment efficacy. Defining barriers and enablers to implement this assessment is important. This analysis aims to evaluate (1) the adherence to the study protocol and (2) the spirometry quality when performing unsupervised home spirometry.
Methods: Home-spirometry sessions from the MiSTIC asthma study (NCT05018598) were evaluated. Home spirometry should be performed once weekly (2 sessions: pre and post-dose) for 26 weeks. Adherence to spirometry assessment was evaluated according to 3 definitions: a) 1 session per week, b) 2 sessions per week or c) 2 sessions exactly every 7 days. Good compliance was considered if 75% of the weeks met the above criteria. Quality assessment was performed on session and trial levels using the AI-based software ArtiQ.QC following modified 2005 ATS/ERS standards.
Results: 228 patients with asthma (34% male, age 54±12 yo) were included in the analysis. 81%, 61% and 14% of the patients were compliant based on the definitions a, b and c respectively. 66% and 62% of the sessions were of quality A or B for FEV1 and FVC, respectively. At the trial level, quality was 97% for FEV1 and 75% for FVC. The most common errors were short efforts (24% lasted <6s), lack of plateaus (89%), and leaks (10%).
Conclusions: A stringent schedule for home spirometry can be challenging for patients to respect. Allowing some flexibility creates more realistic expectations. Overall quality on session-level of home spirometry as average. Nevertheless, patients were able to perform good quality trials, especially for the FEV1 parameter. Producing repeatable measurements was the most challenging. During patient training, specific attention to EOFE is required.
Authors: B. Cuyvers, P. Desbordes, K. Van Orshoven, M. Topalovic, S. Corre, M. Foti, L.Mancini, E. Topole
1. ArtiQ, Leuven, BE
2. Chiesi Farmaceutici, Parma, IT
