Tests a spacer device with triple inhalers in older adults with asthma or COPD
Tests adding a spacer to triple inhaler treatment in older adults with asthma or COPD.
Plain-language title generated from the registry record
Registry title: Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy
Key facts
- Where
- Harbin, Hefei, Ningbo, Ninghai, and Taizhou, ChinaSee the 9 sites
Where in China
- The Second Affiliated Hospital of Harbin Medical UniversityHarbin, ChinaTaking people
- Anhui Chest HospitalHefei, ChinaTaking people
- The Second Affiliated Hospital Of Anhui Medical UniversityHefei, ChinaTaking people
- Beilun District Second People's HospitalNingbo, ChinaTaking people
- Ningbo Medical Center Lihuili HospitalNingbo, ChinaTaking people
- The First Affiliated Hospital of Ningbo UniversityNingbo, ChinaTaking people
- Ninghai County First HospitalNinghai, ChinaTaking people
- Taizhou Central HospitalTaizhou, ChinaNot yet recruiting
- Taizhou Municipal HospitalTaizhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- First Affiliated Hospital of Ningbo University
- Trial code
- NCT07030881
- Record updated
- 26 June 2026
- Original description
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.Read full original descriptionShow less
Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy: A Multicenter Randomized Controlled Trial
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.
Inclusion: Age ≥65 years, no gender restriction; Confirmed diagnosis of chronic obstructive pulmonary disease (COPD) based on GOLD criteria or bronchial asthma based on GINA criteria; Currently on stable treatment with fixed-dose combination ICS/LABA/LAMA via pMDI for ≥4 weeks; History of any of the following in the past 12 months:; ≥1 hospitalization due to exacerbation, or; ≥2 moderate exacerbations requiring systemic corticosteroids and/or antibiotics; Able to complete inhalation technique training and demonstrate basic communication and device-handling abilities; Provides written informed consent to participate in the study.
Exclusion: Use of other inhalation devices as primary therapy (e.g., DPI, SMI, or nebulizer); Regular use of a spacer device for ≥3 weeks within 3 months prior to enrollment; Severe cognitive impairment (MMSE score <18); Presence of severe systemic comorbidities (e.g., end-stage malignancy, advanced heart failure, hepatic or renal failure); Known allergy or hypersensitivity to spacer device materials; Current or recent (within 4 weeks) acute exacerbation not fully resolved; Participation in another interventional clinical trial; Inability to use a mouthpiece-based spacer (e.g., structural oral/facial abnormalities, severe anxiety).