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Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy
Sponsor: First Affiliated Hospital of Ningbo University
Summary
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.
Official title: Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy: A Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
380
Start Date
2025-06-17
Completion Date
2027-06-20
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
pMDI Triple Inhaler and Spacer
Participants in this group will use a valved mouthpiece spacer in combination with standard triple inhaled therapy delivered by a pressurized metered-dose inhaler (ICS/LABA/LAMA). The spacer device helps reduce the need for hand-breath coordination, prolongs aerosol suspension time, and improves drug delivery to the lungs. Participants will be trained in proper spacer use, including device attachment, timing of actuation and inhalation, mouth seal technique, cleaning, and daily maintenance. This intervention aims to optimize inhalation technique, improve treatment adherence, and potentially reduce the incidence of moderate-to-severe exacerbations.
pMDI Triple Inhaler Only
Participants in the control group will receive a standard fixed-dose combination of inhaled corticosteroid (ICS), long-acting beta-agonist (LABA), and long-acting muscarinic antagonist (LAMA) administered via pressurized metered-dose inhaler (pMDI). No spacer will be used. All participants will receive standardized inhalation technique training at baseline, including hand-held device usage, actuation-inhalation timing, breath-hold, and mouth rinsing. This group represents the current standard-of-care for stable, high-risk COPD or asthma patients as per GOLD and GINA guidelines.
Locations (9)
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, China
Anhui Chest Hospital
Hefei, China
Beilun District Second People's Hospital
Ningbo, China
Ningbo Medical Center Lihuili Hospital
Ningbo, China
The First Affiliated Hospital of Ningbo University
Ningbo, China
Ninghai County First Hospital
Ninghai, China
Taizhou Central Hospital
Taizhou, China
Taizhou Municipal Hospital
Taizhou, China