Remote monitoring of patients with chronic obstructive pulmonary disease: results of a multicentre pilot study

Objective. To evaluate the results of a multicentre randomized pilot study of remote monitoring (RM) in patients with chronic obstructive pulmonary disease (COPD). Material and methods. A multicentre, randomized, open-label study. Patients with a verified diagnosis of COPD were randomized 1:1 to either the RM group or the standard follow-up care group (control): a total of 67 patients were enrolled (RM — 33, control — 34). The participation duration was 14 weeks. This paper presents the results of the analysis of patients enrolled at the time of publication preparation (Sechenov University centre). The analysis was performed in the mITT population (N=55: RM 29 patients, control 26). The primary endpoint included: relative change in FEV1, absolute change in the frequency of short-acting bronchodilator (SABD) use, and estimated annual exacerbation rate of COPD at week 12. Results. The relative change in FEV1 at week 12 was +2.65% in the RM group and −6.55% in the control group; the absolute FEV1 value was 70.15% vs 59.99% of predicted (p=0.164). The RM group showed a reduction in the estimated annual COPD exacerbation rate (1.38 vs 2.12; p=0.016); however, this result requires cautious interpretation given the correction for multiple comparisons; the categorical distribution of exacerbations differed significantly (p=0.008). The frequency of SABD use at week 12 was 1.19 vs 1.69 doses/day (p=0.098). The CAT score consistently decreased in the RM group: −2.04 (p=0.021), −2.91 (p=0.020), and −3.33 (p=0.012) at weeks 2, 6, and 12, respectively. The proportion of patients with severe dyspnoea on the Borg scale (≥5 points) was significantly lower in the RM group at week 12 (p=0.027). Mean adherence to monitoring exceeded 80% across all parameters. No unplanned healthcare visits were recorded in the RM group vs 3 cases (11.54%) in the control group (p=0.099). Conclusion. The RM group demonstrated a reduction in the estimated annual COPD exacerbation rate, as well as sustained positive trends in functional and symptomatic outcomes. High patient adherence confirms the feasibility of the RM programme in real-world practice. The findings highlight the need to continue the study in order to obtain more robust data.