Actively Recruiting
Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy
Led by First Affiliated Hospital of Ningbo University · Updated on 2026-04-06
380
Participants Needed
9
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 maximum inhaled treatment, 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 face-mask 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.
CONDITIONS
Official Title
Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older, any gender
- Confirmed diagnosis of COPD based on GOLD criteria or asthma based on GINA criteria
- Stable treatment with fixed-dose ICS/LABA/LAMA via pMDI for at least 4 weeks
- History in past 12 months of either at least 1 hospitalization due to exacerbation or at least 2 moderate exacerbations needing corticosteroids and/or antibiotics
- Ability to complete inhalation technique training and basic communication and device-handling skills
- Provides written informed consent to participate
You will not qualify if you...
- Use of other inhalation devices as main therapy (e.g., DPI, SMI, or nebulizer)
- Regular spacer use for 3 or more weeks within 3 months before enrollment
- Current or recent acute exacerbation within 4 weeks not fully resolved
- Severe cognitive impairment (MMSE score less than 18)
- Severe systemic diseases such as end-stage cancer, advanced heart failure, liver or kidney failure
- Participation in another interventional clinical trial
- Inability to use a mouthpiece spacer due to structural oral/facial issues or severe anxiety
- Known allergy or sensitivity to spacer materials
AI-Screening
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Trial Site Locations
Total: 9 locations
1
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
2
The Second Affiliated Hospital of Harbin Medical University
Harbin, China
Actively Recruiting
3
Anhui Chest Hospital
Hefei, China
Actively Recruiting
4
Beilun District Second People's Hospital
Ningbo, China
Actively Recruiting
5
Ningbo Medical Center Lihuili Hospital
Ningbo, China
Actively Recruiting
6
The First Affiliated Hospital of Ningbo University
Ningbo, China
Actively Recruiting
7
Ninghai County First Hospital
Ninghai, China
Actively Recruiting
8
Taizhou Central Hospital
Taizhou, China
Not Yet Recruiting
9
Taizhou Municipal Hospital
Taizhou, China
Actively Recruiting
Research Team
C
Chao Cao
CONTACT
S
Shiyi He
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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