Spacer use with triple inhaler therapy to reduce flare-ups in older adults with COPD or asthma

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 tests whether adding a valved face‑mask spacer to a pMDI triple inhaler can reduce moderate-to-severe exacerbations in people aged 65+ with asthma or COPD who are at high risk.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 380 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital of Ningbo University (Research network)
• Locations: 9 sites (Hefei, Anhui and 8 other locations)
• Trial ID: NCT07030881 on ClinicalTrials.gov

What this trial studies

This is a multicenter, open‑label randomized controlled trial enrolling 380 participants aged 65 or older with physician‑confirmed COPD or asthma who are on stable fixed‑dose pMDI ICS/LABA/LAMA therapy. Participants meeting high‑risk criteria (≥1 hospitalization or ≥2 moderate exacerbations in the past 12 months) are randomized to continue pMDI triple therapy with or without a valved face‑mask spacer. The primary outcome is the incidence of moderate‑to‑severe exacerbations over 3 months. Secondary outcomes include lung function, medication adherence, inhalation technique, local side effects, and patient satisfaction.

Who should consider this trial

Good fit: Ideal candidates are people aged 65 or older with confirmed COPD or asthma who have been on stable fixed‑dose pMDI ICS/LABA/LAMA for at least 4 weeks, have had ≥1 hospitalization or ≥2 moderate exacerbations in the past year, and can complete basic device training.

Not a fit: Patients who primarily use other inhaler types (DPI, SMI, or nebulizer), who already use a spacer regularly, who have severe cognitive impairment, or who are in an unresolved acute exacerbation are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, adding a spacer could lower moderate-to-severe exacerbations, improve medication delivery and adherence, and reduce local side effects in high-risk older adults.

How similar studies have performed: Prior research shows spacers improve pMDI drug delivery, technique, and some local side effects, but randomized evidence that spacers reduce exacerbations in high‑risk older adults on triple therapy is limited.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui and 8 other locations

• The Second Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
• The Second Affiliated Hospital of Harbin Medical University — Harbin, China (Recruiting)
• Anhui Chest Hospital — Hefei, China (Recruiting)
• Beilun District Second People's Hospital — Ningbo, China (Recruiting)
• Ningbo Medical Center Lihuili Hospital — Ningbo, China (Recruiting)
• The First Affiliated Hospital of Ningbo University — Ningbo, China (Recruiting)
• Ninghai County First Hospital — Ninghai, China (Recruiting)
• Taizhou Central Hospital — Taizhou, China (Not_yet_recruiting)
• Taizhou Municipal Hospital — Taizhou, China (Recruiting)

Study contacts

• Study coordinator: Chao Cao

Conditions Asthma, COPD