Status:
RECRUITING
Effectiveness of DITM Versus IMT in COPD Patients
Lead Sponsor:
Sir Run Run Shaw Hospital
Collaborating Sponsors:
Jingyao (Hangzhou) Health Technology Co., Ltd.
Conditions:
COPD (Chronic Obstructive Pulmonary Disease)
Eligibility:
All Genders
40+ years
Phase:
NA
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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT06958666
Start Date
June 30 2025
End Date
May 1 2028
Last Update
July 17 2025
Active Locations (1)
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1
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310016