Condition: COPD (Chronic Obstructive Pulmonary Disease) · Sponsor: Sir Run Run Shaw Hospital
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…
This description comes directly from the study's public registry record.
Yiqing Xu, MPH, MSRC · +86 13634115344 · xuyiqing@srrsh.com
Huiqing Ge, MD · +86 13588706787 · gehq@zju.edu.cn
Always discuss trial participation with your own doctor first.
| 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 |
| Taizhou Integrated Traditional Chinese and Western Medicine Hospital | Taizhou, Zhejiang, China | Recruiting |
| Department of Respiratory Care, Taizhou Central Hospital | Taizhou, Zhejiang, China | Recruiting |
| Department of Respiratory and Critical Care Medicine Wenling First People's Hospital | Taizhou, Zhejiang, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06958666