RecruitingNot ApplicableNCT06958666

Effectiveness of DITM Versus IMT in COPD Patients

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

Sponsor

Sir Run Run Shaw Hospital

Enrollment

410 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

COPD, Chronic Obstructive Pulmonary Disease

Summary

The goal of this clinical trial is to learn if digital inhaled therapy management (DITM) and inspiratory muscle training (IMT), alone or in combination, can improve outcomes in adults aged 40 years and older with symptomatic, high-risk chronic obstructive pulmonary disease (COPD) with moderate to severe airflow limitation (FEV1/FVC \< 60%). The main questions it aims to answer are: Does DITM reduce the rate of moderate to severe COPD exacerbations and hospitalizations compared to usual care? Does IMT reduce the rate of moderate to severe COPD exacerbations and hospitalizations compared to usual care? Does the combination of DITM and IMT reduce the rate of moderate to severe COPD exacerbations and hospitalizations compared to usual care? What are the effects of DITM, IMT, and their combination on the time to first moderate to severe exacerbation, COPD Assessment Test (CAT) score, modified Medical Research Council (mMRC) score, and St. George's Respiratory Questionnaire for chronic obstructive pulmonary disease (SGRQ-C) score? Researchers will compare four groups: a DITM group, an IMT group, a DITM+IMT group, and a control group receiving usual care, to see if these interventions improve outcomes related to COPD exacerbations, symptoms, quality of life, and inspiratory muscle strength. Participants will: DITM Group: Receive training on inhaler technique using a digital device and use a digital sensor with a mobile app for home-based inhalation management, including reminders and feedback. IMT Group: Receive verbal inhaler technique training and use a breathing trainer with accompanying software for inspiratory muscle training. DITM+IMT Group: Receive both the digital inhalation management and inspiratory muscle training interventions. Control Group: Receive verbal inhaler technique training only. All participants will undergo baseline assessments and follow-up assessments at 3, 6, and 12 months, including questionnaires, lung function tests, respiratory muscle strength measurements, and a 6-minute walk test. They will also report on any COPD exacerbations experienced during the study period.

Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different breathing exercise programs for people with COPD (chronic obstructive pulmonary disease): diaphragmatic and inspiratory training (DITM) — focusing on breathing muscles — versus standard inspiratory muscle training (IMT). The goal is to see which program better improves breathing capacity and quality of life. **You may be eligible if...** - You have been diagnosed with COPD confirmed by breathing tests (FEV1/FVC less than 60%) - Your COPD is stable (not in a flare-up) - You have significant symptoms: either a CAT score of 10 or more, an mMRC breathlessness score of 2 or more, or at least 2 moderate exacerbations in the past year - You are currently using a budesonide-containing inhaled corticosteroid (ICS) **You may NOT be eligible if...** - You are currently in a COPD flare-up - You have a condition that makes breathing exercises unsafe (such as severe heart disease) - You have significant breathing limitations from non-COPD causes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDigital Inhaled Therapy Management

The subjects will be trained on their inhalation techniques with the "Digital Medication Administration Device" consists of an inhalation device with a display and inhalation technique assessment module. The device will show a standardized video demonstration and will evaluate the subjects' inhalation technique. A printed report will be available afterwards. A home-based inhalation management service package will be provided to the subjects including a digital sensor that records the time, frequency, and key inhalation technique parameters for each use of metered-dose inhalers or dry powder inhalers, and automatically synchronizes the data to the cloud. The data is then analyzed for adherence and technique performance. Based on the data, subjects will receive medication reminders and voice alerts for any technique errors on the app provided with the package. Visual charts of medication adherence and inhalation technique will be available to reinforce self-management.

DEVICEInspiratory Muscle Training

The subjects will receive standardized verbal training and demonstration of inhalation techniques and any questions will be answered Inspiratory muscle training equipment, ancillary software, inspiratory muscle training plan, and equipment user guide will be sent home with the patient.