Clinical trial NCT06958666: Effectiveness of DITM Versus IMT in COPD Patients
Official title: Effectiveness of DITM Versus IMT in COPD Patients With High Symptom Burden and High Risk of Acute Exacerbation: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Keywords: Pulmonary Rehabilitation
COPD
GOLD2024
Global Initiative for Chronic Obstructive Lung Disease
Digital Inhaled Therapy Management
Inspiratory Muscle Training
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
Collaborators: name: Jingyao (Hangzhou) Health Technology Co., Ltd.
First posted: 2025-05-06
Enrollment: 410
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of acute exacerbation of moderate-to-severe COPD and hospitalization during follow-up period
timeFrame: Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training
Secondary outcomes:
measure: Days to first Moderate-to-Severe Acute Exacerbation
timeFrame: Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training
measure: COPD Assessment Test (CAT) Score
timeFrame: Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training
measure: Modified Medical Research Council (mMRC) Dyspnea Score
timeFrame: Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training
measure: St. George's Respiratory Questionnaire (SGRQ) Score
timeFrame: assessed only during the last two follow ups (6 months and 12 months).
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Huiqing Ge, MD
role: PRINCIPAL_INVESTIGATOR
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