Digital inhaler management versus inspiratory muscle training for COPD
Effectiveness of DITM Versus IMT in COPD Patients With High Symptom Burden and High Risk of Acute Exacerbation: A Randomized Controlled Study
This trial will try digital inhaled therapy management and inspiratory muscle training, alone or together, to see if they cut exacerbations and hospital visits in people aged 40 and older with symptomatic moderate-to-severe COPD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 410 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Sir Run Run Shaw Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06958666 on ClinicalTrials.gov |
What this trial studies
Adults meeting GOLD2024 criteria for COPD with FEV1/FVC < 60% are assigned to receive digital inhaled therapy management (DITM), inspiratory muscle training (IMT), both interventions, or usual care. The study compares rates of moderate-to-severe COPD exacerbations and hospitalizations across these groups. Secondary measures include time to first moderate-to-severe exacerbation and patient-reported outcomes such as CAT, mMRC, and the St. George's Respiratory Questionnaire. Participants must be on specified maintenance inhalers and attend study visits at the sponsoring site in Hangzhou, Zhejiang.
Who should consider this trial
Good fit: Adults aged 40 or older with symptomatic, high-risk COPD (FEV1/FVC < 60%) who have significant symptoms (CAT ≥10 or mMRC ≥2) or recent exacerbation history, and who use one of the specified maintenance inhalers, are the intended participants.
Not a fit: People with unstable cardiac disease, severe fatigue from advanced heart failure or chemotherapy, unstable psychiatric illness, severe cognitive impairment, or those not on the specified maintenance inhalers are not eligible and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the interventions could lower exacerbation and hospitalization rates and improve symptoms and quality of life for people with high-risk COPD.
How similar studies have performed: Prior studies of digital inhaler management and of inspiratory muscle training have shown mixed but sometimes promising effects on adherence, symptoms, and breathing muscle strength, while the combined approach remains less well tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Huiqing Ge, MD — Sir Run Run Shaw Hospital
- Study coordinator: Yiqing Xu, MPH, MSRC
- Email: xuyiqing@srrsh.com
- Phone: +86 13634115344
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.