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

First Affiliated Hospital of Ningbo University

Status: Not yet enrolling

Conditions: Asthma, COPD

Treatments: Drug: pMDI Triple Inhaler Only; Drug: pMDI Triple Inhaler and Spacer

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT07030881

2025-146A-01

Details and patient eligibility

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.

Enrollment: 380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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380 participants in 2 patient groups

Standard Therapy Group

Active Comparator group

Description:

Participants will receive standard triple inhaled therapy using a pressurized metered-dose inhaler (ICS/LABA/LAMA). They will receive routine inhalation technique training but will not use a spacer device.

Treatment:

Drug: pMDI Triple Inhaler Only

Spacer Group

Experimental group

Description:

Participants will receive the same standard triple inhaled therapy via pMDI (ICS/LABA/LAMA) plus a valved mouthpiece spacer. Inhalation technique training will include proper spacer usage, including attachment, mouth seal, actuation timing, and cleaning. The spacer is intended to optimize pulmonary drug delivery, reduce the need for hand-breath coordination, and minimize local side effects.

Treatment:

Drug: pMDI Triple Inhaler and Spacer