Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 380
- 试验地点
- 9
- 主要终点
- Incidence of Moderate-to-Severe Acute Exacerbations Within 3 Months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard Therapy Group
Participants will receive standard triple inhaled therapy using a pressurized metered-dose inhaler (ICS/LABA/LAMA). They will receive routine inhalation technique training but will not use a spacer device.
干预措施: pMDI Triple Inhaler Only (Drug)
Spacer Group
Participants will receive the same standard triple inhaled therapy via pMDI (ICS/LABA/LAMA) plus a valved mouthpiece spacer. Inhalation technique training will include proper spacer usage, including attachment, mouth seal, actuation timing, and cleaning. The spacer is intended to optimize pulmonary drug delivery, reduce the need for hand-breath coordination, and minimize local side effects.
干预措施: pMDI Triple Inhaler and Spacer (Other)
结局指标
主要结局
Incidence of Moderate-to-Severe Acute Exacerbations Within 3 Months
时间窗: Baseline, 3 months
Moderate exacerbation is defined as a worsening of respiratory symptoms requiring treatment with systemic corticosteroids and/or antibiotics. Severe exacerbation is defined as requiring emergency department visit or hospitalization. All events must be confirmed by the treating physician and recorded in the case report form (CRF). This outcome evaluates whether the use of a valved spacer reduces the rate of such events compared to standard therapy alone.
次要结局
- Change in Treatment Adherence Score (MARS Questionnaire) From Baseline to 3 and 6 Months(Baseline, 3 months, and 6 months)
- Change in Post-Bronchodilator FEV₁ From Baseline to 3 Months(Baseline and 3 months)
- Time to First Moderate-to-Severe Acute Exacerbation(Baseline, 3 months)
- Change in Inhalation Technique Score From Baseline to 3 Months(Baseline, 3 months)
- Change in Local Side Effect Score (ICS-Related)(Baseline, 1, 2, 3 months)
- Change in Patient Satisfaction Score (VAS)(3 and 6 months)
- Asthma Control Level Based on Four GINA-Recommended Indicators(Baseline and 3 months)
研究者
Chao Cao, Ph.D.
Principal Investigator
First Affiliated Hospital of Ningbo University