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

Официальное название

Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy: A Multicenter Randomized Controlled Trial

Обзор

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.

Вмешательства

• Другое 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
• Препарат 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

Первичные конечные точки

• Incidence of Moderate-to-Severe Acute Exacerbations Within 3 Months [Срок оценки: Baseline, 3 months]

Вторичные конечные точки (7)

• Change in Post-Bronchodilator FEV₁ From Baseline to 3 Months [Срок оценки: Baseline and 3 months]
• Change in Treatment Adherence Score (MARS Questionnaire) From Baseline to 3 and 6 Months [Срок оценки: Baseline, 3 months, and 6 months]
• Time to First Moderate-to-Severe Acute Exacerbation [Срок оценки: Baseline, 3 months]
• Change in Inhalation Technique Score From Baseline to 3 Months [Срок оценки: Baseline, 3 months]
• Change in Local Side Effect Score (ICS-Related) [Срок оценки: Baseline, 1, 2, 3 months]
• Change in Patient Satisfaction Score (VAS) [Срок оценки: 3 and 6 months]
• Asthma Control Level Based on Four GINA-Recommended Indicators [Срок оценки: Baseline and 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 9 центров

• The Second Affiliated Hospital of Anhui Medical University — Хэфэй
• The Second Affiliated Hospital of Harbin Medical University — Харбин
• Anhui Chest Hospital — Хэфэй
• Beilun District Second People's Hospital — Ningbo
• Ningbo Medical Center Lihuili Hospital — Ningbo
• The First Affiliated Hospital of Ningbo University — Ningbo
• Ninghai County First Hospital — Ninghai
• Taizhou Central Hospital — Taizhou
• … и ещё 1 центр

Идентификаторы

NCT: NCT07030881 · 2025-146A-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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