Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy
报名条件（概要）
- 年龄：65 Years – 不限
- 性别：不限
- 健康志愿者：不接受
完整入排标准请以官方页面为准。
开展国家/地区
China
研究药物 / 干预措施
pMDI Triple Inhaler and Spacer、pMDI Triple Inhaler Only
申办方
First Affiliated Hospital of Ningbo University
研究简介（原文）
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.
适应症
主动联系研究团队
总联系人（申办方／研究总部）
中国／港澳台研究中心
- The Second Affiliated Hospital of Anhui Medical UniversityHefei，Anhui，China
- The Second Affiliated Hospital of Harbin Medical UniversityHarbin，China
- Anhui Chest HospitalHefei，China
- Beilun District Second People's HospitalNingbo，China
- Ningbo Medical Center Lihuili HospitalNingbo，China
- The First Affiliated Hospital of Ningbo UniversityNingbo，China
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英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy ClinicalTrials.gov Identifier: NCT07030881 Sponsor: First Affiliated Hospital of Ningbo University Investigational product: pMDI Triple Inhaler and Spacer, pMDI Triple Inhaler Only About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy 试验编号：NCT07030881 申办方：First Affiliated Hospital of Ningbo University 研究药物：pMDI Triple Inhaler and Spacer、pMDI Triple Inhaler Only 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。
下一步怎么做？
- 把本页信息带给您的主治医生，评估是否适合参加。
- 点击下方按钮打开官方注册页，查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。