NCT06958666Recruiting
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
Source: ClinicalTrials.gov · Last updated 24 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 410 (estimated)
- First submitted
- 16 Apr 2025
- Start date
- 30 Jun 2025
- Primary completion date
- May 2028
- Lead sponsor
- Sir Run Run Shaw Hospital
- Diseases
- COPD
- NCT number
- NCT06958666
What you commit to
- Study type: Interventional
- Planned participants: 410
- From 30 Jun 2025 to the primary completion date, May 2028
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Vulnerable populations other than the elderly, including individuals with mental illness, cognitive impairment, critically ill patients, illiterate individuals, etc.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Zhejiang Provincial Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Jinyun County Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Lishui | China | Recruiting |
| Department of Respiratory and Critical Care Medicine, Linhai Second People's Hospital, 198 Dubei Road, Duqiao Town Coordinator of this site? Confirm its status | Taizhou | China | Recruiting |
| Taizhou Integrated Traditional Chinese and Western Medicine Hospital Coordinator of this site? Confirm its status | Taizhou | China | Recruiting |
| Department of Respiratory Care, Taizhou Central Hospital Coordinator of this site? Confirm its status | Taizhou | China | Recruiting |
| Taizhou Hospital of Zhejiang Province Coordinator of this site? Confirm its status | Taizhou | China | Recruiting |
| Department of Respiratory and Critical Care Medicine Wenling First People's Hospital Coordinator of this site? Confirm its status | Taizhou | China | Recruiting |
| Zhejiang Xianju County People's Hospital Coordinator of this site? Confirm its status | Taizhou | China | Recruiting |
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This page is information, not medical advice. Discuss any trial with your doctor.