Effectiveness of DITM Versus IMT in COPD Patients With High Symptom Burden and High Risk of Acute Exacerbation: A Randomized Controlled Study

What this Trial Is About

This research aims to evaluate if digital inhaled therapy management (DITM) and inspiratory muscle training (IMT), alone or combined, can improve outcomes for adults aged 40 and older with symptomatic, high-risk chronic obstructive pulmonary disease (COPD) who have moderate to severe airflow limitation. The study investigates whether these interventions reduce the rate of moderate to severe COPD exacerbations and hospitalizations, and their effects on symptom scores and quality of life compared to usual care. Participants will be randomly assigned to one of four groups: a DITM group receiving training with a digital inhaler device and a mobile app that provides reminders and feedback; an IMT group receiving verbal inhaler training along with breathing trainer equipment and software; a combined DITM+IMT group receiving both interventions; and a control group receiving only verbal inhaler technique training. The interventions are provided for home use and include detailed training and support. Throughout the study, participants will undergo baseline assessments, then follow-up visits at 3, 6, and 12 months. Assessments include questionnaires on COPD symptoms and quality of life, lung function tests, respiratory muscle strength measurements, and a 6-minute walk test. Participants will also report any COPD exacerbations during the study. Researchers will measure rates of exacerbations and hospitalizations, time to first exacerbation, and changes in symptom scores and quality of life to understand the impact of these interventions over one year.

Effectiveness of DITM Versus IMT in COPD Patients