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Effectiveness of DITM Versus IMT in COPD Patients

RecruitingNAAges 40 Years - anyAllSir Run Run Shaw Hospital
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In plain words

What the trial is, and whether it could suit you

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, modifie

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ10 or mMRCโ‰ฅ2; (B) โ‰ฅ2 moderate acute exacerbation or โ‰ฅ1 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.
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What it tests

  • Digital Inhaled Therapy Management
  • Inspiratory Muscle Training
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Where

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

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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