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NCT Number: NCT06958666

Effectiveness of DITM Versus IMT in COPD Patients

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.

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Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digital Inhaled Therapy Management

Device

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.

Inspiratory muscle training

Device

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.

Primary outcomes

  1. Rate of acute exacerbation of moderate-to-severe COPD and hospitalization during follow-up period

    Time frame: 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 outcomes

  1. Days to first Moderate-to-Severe Acute Exacerbation

    Time frame: 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.

  2. COPD Assessment Test (CAT) Score

    Time frame: 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.

  3. Modified Medical Research Council (mMRC) Dyspnea Score

    Time frame: 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.

  4. St. George's Respiratory Questionnaire (SGRQ) Score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huiqing Ge, MD

CONTACT

[email protected]

+86 13588706787

Yiqing Xu, MPH, MSRC

CONTACT

[email protected]

+86 13634115344

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Collaborators

  • Jingyao (Hangzhou) Health Technology Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 6, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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