Digital inhaler management versus inspiratory muscle training for COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zhejiang Provincial Hospital of Traditional Chinese Medicine
  Hangzhou, Zhejiang, China Recruiting
• Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting
• Jinyun County Hospital of Traditional Chinese Medicine
  Lishui, Zhejiang, China Recruiting
• Taizhou Hospital of Zhejiang Province
  Taizhou, Zhejiang, China Recruiting
• Department of Respiratory and Critical Care Medicine, Linhai Second People's Hospital, 198 Dubei Road, Duqiao Town
  Taizhou, Zhejiang, China Recruiting
• Zhejiang Xianju County People's Hospital
  Taizhou, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.