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

Recruiting now · Not applicable

Conditions studied: Asthma, COPD

In brief

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.

Key facts

Study ID

NCT07030881

Run by

First Affiliated Hospital of Ningbo University

People needed

380

Starts

2025-06-17

Expected to finish

2027-06-30

Last updated by the study team

2026-06-26

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

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

Full record on ClinicalTrials.gov

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