Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy
Recruiting · NCT07030881 · Interventional (participants receive a specific treatment) · Lead sponsor: First Affiliated Hospital of Ningbo University
View the official record on ClinicalTrials.gov →Interventions studied
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 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.
Who can take part
Inclusion criteria
- 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 criteria
- 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;
- Current or recent (within 4 weeks) acute exacerbation not fully resolved;
- Severe cognitive impairment (MMSE score \<18);
- Presence of severe systemic comorbidities (e.g., end-stage malignancy, advanced heart failure, hepatic or renal failure);
- Participation in another interventional clinical trial;
- Inability to use a mouthpiece-based spacer (e.g., structural oral/facial abnormalities, severe anxiety);
- Known allergy or hypersensitivity to spacer device materials.
Where it is running
18 locations listed.
- The Second Affiliated Hospital of Harbin Medical University - Harbin, China
- The Second Affiliated Hospital of Harbin Medical University - Harbin, China
- Anhui Chest Hospital - Hefei, China
- Anhui Chest Hospital - Hefei, China
- Beilun District Second People's Hospital - Ningbo, China
- Ningbo Medical Center Lihuili Hospital - Ningbo, China
- The First Affiliated Hospital of Ningbo University - Ningbo, China
- Beilun District Second People's Hospital - Ningbo, China
- Ningbo Medical Center Lihuili Hospital - Ningbo, China
- The First Affiliated Hospital of Ningbo University - Ningbo, China
- Ninghai County First Hospital - Ninghai, China
- Ninghai County First Hospital - Ninghai, China
- Taizhou Central Hospital - Taizhou, China
- Taizhou Municipal Hospital - Taizhou, China
- Taizhou Central Hospital - Taizhou, China
- Taizhou Municipal Hospital - Taizhou, China
- The Second Affiliated Hospital of Anhui Medical University - Hefei, Anhui, China
- The Second Affiliated Hospital of Anhui Medical University - Hefei, Anhui, China