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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Chao Cao
• Email: caocdoctor@163.com
• Phone: +86-0574-87089878

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.