Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy

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 Criteria:

1. Age ≥65 years, no gender restriction;

2. Confirmed diagnosis of chronic obstructive pulmonary disease (COPD) based on GOLD criteria or bronchial asthma based on GINA criteria;

3. Currently on stable treatment with fixed-dose combination ICS/LABA/LAMA via pMDI for ≥4 weeks;

4. History of any of the following in the past 12 months:

   1. ≥1 hospitalization due to exacerbation, or
   2. ≥2 moderate exacerbations requiring systemic corticosteroids and/or antibiotics;

5. Able to complete inhalation technique training and demonstrate basic communication and device-handling abilities;

6. Provides written informed consent to participate in the study.

Exclusion Criteria:

1. Use of other inhalation devices as primary therapy (e.g., DPI, SMI, or nebulizer);
2. Regular use of a spacer device for ≥3 weeks within 3 months prior to enrollment;
3. Current or recent (within 4 weeks) acute exacerbation not fully resolved;
4. Severe cognitive impairment (MMSE score <18);
5. Presence of severe systemic comorbidities (e.g., end-stage malignancy, advanced heart failure, hepatic or renal failure);
6. Participation in another interventional clinical trial;
7. Inability to use a mouthpiece-based spacer (e.g., structural oral/facial abnormalities, severe anxiety);
8. Known allergy or hypersensitivity to spacer device materials.