Effectiveness of digital inhaled therapy management and respiratory muscle training in moderate to severe COPD...

Digital inhaler therapy management can help patients promote adherence and correct inhaler techniques. Poor inhaler technique and suboptimal adherence contribute to COPD exacerbations, uncontrolled symptoms, and a progressive decline in pulmonary function. Digital Inhaled Therapy Management (DITM) platforms can provide standardized technique training, objective adherence monitoring, and real-time feedback. Respiratory Muscle Training is a recommended component of pulmonary rehabilitation that can improve respiratory muscle strength and exercise tolerance. Whether DITM and IMT, alone or in combination, reduce exacerbations and improve patient-reported and physiologic outcomes compared with usual care remains uncertain.

This is a 1-year, multicenter, open-label, assessor-blinded, randomized, parallel-group superiority trial with participants randomly allocated to four arms (1:1:1:1): DITM, IMT, DITM + IMT, and usual care (verbal inhaler education). Adults ≥ 40 years with COPD per GOLD 2024, FEV1%pred < 60, symptomatic burden (e.g., CAT ≥ 10 and/or mMRC ≥ 2), and high risk of exacerbation (≥ 2 moderate or ≥ 1 severe in past 12 months) will be enrolled (N = 410). Follow-up contacts occur at 3, 6, and 12 months. The primary outcome timepoint is the cumulative 12-month rate of moderate-to-severe COPD exacerbations,with severe events defined as COPD-related hospitalizations, the 3-and 6-month contacts are used for event ascertainment and not as separate primary timepoint. Secondary outcomes include time to first moderate-to-severe exacerbation, CAT, mMRC, SGRQ-C, spirometry, inspiratory muscle strength (MIP/MEP), 6-min walk test, and device-derived metrics of inhaler adherence and technique. Analyses will follow intention-to-treat principles, using negative binomial or Poisson regression for exacerbation rates, Cox models for time-to-event outcomes, and mixed-effects models for repeated continuous outcomes.

This trial will evaluate the effectiveness of DITM and IMT-alone and combined-on exacerbations, symptoms, and function in high-risk COPD. Findings may inform integration of digital self-management and inspiratory muscle training into routine COPD care.

ClinicalTrials.gov NCT06958666; registered in July 2025. Ethics approved was obtained from the Ethics Committee of Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (Approval No. 20250119).