Effectiveness of DITM Versus IMT in COPD Patients

Not Applicable

Not yet recruiting

• Conditions: COPD (Chronic Obstructive Pulmonary Disease)

• Registration Number: NCT06958666
• Lead Sponsor: Sir Run Run Shaw Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-04-16
• Study First Submitted QC: 2025-04-25
• Last Update Submitted: 2025-04-25
• Study Start: 2025-05
• Study First Posted: 2025-05-06
• Last Update Posted: 2025-05-06
• Primary Completion: 2028-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 410

Inclusion Criteria

• Diagnosed as COPD according to "GOLD2024"
• Lung function results FEV1/FVC<60%
• Patients with stable COPD who meet one of the following criteria: (A)with CAT score ≥10 or mMRC≥2; (B) ≥2 moderate acute exacerbation or ≥1 hospitalization in the past 12 months
• Uses Budesonide MDI (Breztri Aerosphere) or Fluticasone, umeclidinium, and vilanterol (Trelegy Ellipta) or umeclidinium and vilanterol (Anoro Ellipta) as maintenance drug for COPD management
• Volunteer to participate in this study and sign the informed consent form. If the subject is unable to read and sign the informed consent form due to incapacity, his/her guardian shall act on his/her behalf to read and sign the informed consent form.

Exclusion Criteria

• Unstable angina or severe arrhythmia
• Severe weakness-related fatigue, such as in advanced congestive heart failure or chemotherapy-related fatigue
• Unstable mental illness with a risk of self-harm or harm to others
• Severe cognitive impairment, progressive neuromuscular disease
• Pregnant and breastfeeding women
• Life expectancy of less than 6 months
• Pregnant and breastfeeding women
• Inability to cooperate with pulmonary function tests
• Inability to complete the entire follow-up period
• Vulnerable populations other than the elderly, including individuals with mental illness, cognitive impairment, critically ill patients, illiterate individuals, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of acute exacerbation of moderate-to-severe COPD and hospitalization during follow-up period	Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training	Rate of acute exacerbation of moderate-to-severe COPD and hospitalization during follow-up period will be accessed as the primary endpoint. Acute exacerbation of COPD is defined according to the "Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbation of COPD" 2023 version.

Secondary Outcome Measures

Name	Time	Method
Days to first Moderate-to-Severe Acute Exacerbation	Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training	Time from baseline to the occurrence of the first acute exacerbation in days.
COPD Assessment Test (CAT) Score	Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training	Self-reported measure of health status in COPD patients, assessed using the CAT questionnaire. Higher scores indicate a greater impact of COPD on daily life.
Modified Medical Research Council (mMRC) Dyspnea Score	Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training	Patient-rated scale assessing the severity of breathlessness. Higher grade indicates higher severity.
St. George's Respiratory Questionnaire (SGRQ) Score	assessed only during the last two follow ups (6 months and 12 months).	Quality of life assessment specific to respiratory diseases. Higher scores reflect worse health-related quality of life.

Trial Locations

Locations (1)

Sir Run Run Shaw Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China