Condition: Asthma, COPD · Sponsor: First Affiliated Hospital of Ningbo University
This study evaluates whether adding a spacer device to triple inhaled therapy (ICS/LABA/LAMA via pMDI) can reduce acute exacerbations in elderly patients (≥65 years) with stable chronic airway diseases (COPD or asthma) who are classified as high-risk based on GOLD or GINA guidelines. High risk is defined as ≥1 hospitalization or ≥2 moderate exacerbations in the past 12 months. Despite receiving triple inhaled therapy, these patients often have poor inhaler technique due to age-related limitations. A spacer may improve drug delivery, adherence, and reduce local side effects. In this multicenter, open-label, randomized controlled trial, 380 participants will be assigned to standard therapy with or without a valved spacer. The primary outcome is the 3-month incidence of moderate-to-severe exacerbations. Secondary outcomes include lung function, adherence, inhalation technique, side effects, and patient satisfaction.
This description comes directly from the study's public registry record.
Chao Cao · +86-0574-87089878 · caocdoctor@163.com
Shiyi He · +86-0574-87089878 · shiyihii@163.com
Always discuss trial participation with your own doctor first.
| The Second Affiliated Hospital of Anhui Medical University | Hefei, Anhui, China | Recruiting |
| The Second Affiliated Hospital of Harbin Medical University | Harbin, China | Recruiting |
| Anhui Chest Hospital | Hefei, China | Recruiting |
| Beilun District Second People's Hospital | Ningbo, China | Recruiting |
| Ningbo Medical Center Lihuili Hospital | Ningbo, China | Recruiting |
| The First Affiliated Hospital of Ningbo University | Ningbo, China | Recruiting |
| Ninghai County First Hospital | Ninghai, China | Recruiting |
| Taizhou Central Hospital | Taizhou, China | Not Yet Recruiting |
| Taizhou Municipal Hospital | Taizhou, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07030881