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

RecruitingNAAges 65 Years - anyAllFirst Affiliated Hospital of Ningbo University
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In plain words

What the trial is, and whether it could suit you

This study evaluates whether adding a spacer device to triple inhaled therapy (ICS/LABA/LAMA via pMDI) can reduce acute exacerbations in elderly patients (โ‰ฅ65 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 โ‰ฅ1 hospitalization or โ‰ฅ2 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 effect

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ65 years, no gender restriction; 2. Confirmed diagnosis of chronic obstructive pulmonary disease (COPD) based on GOLD criteria or bronchial asthma based on GINA criteria; 3. Currently on stable treatment with fixed-dose combination ICS/LABA/LAMA via pMDI for โ‰ฅ4 weeks; 4. History of any of the following in the past 12 months: 1. โ‰ฅ1 hospitalization due to exacerbation, or 2. โ‰ฅ2 moderate exacerbations requiring systemic corticosteroids and/or antibiotics; 5. Able to complete inhalation technique training and demonstrate basic communication and device-handling abilities; 6. Provides written informed consent to participate in the study. Exclusion Criteria: 1. Use of other inhalation devices as primary therapy (e.g., DPI, SMI, or nebulizer); 2. Regular use of a spacer device for โ‰ฅ3 weeks within 3 months prior to enrollment; 3. Current or recent (within 4 weeks) acute exacerbation not fully resolved; 4. Severe cognitive impairment (MMSE score \<18); 5. Presence of severe systemic comorbidities (e.g., end-stage malignancy, advanced heart failure, hepatic or renal failure); 6. Participation in another interventional clinical trial; 7. Inability to use a mouthpiece-based spacer (e.g., structural oral/facial abnormalities, severe anxiety); 8. Known allergy or hypersensitivity to spacer device materials.
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What it tests

  • pMDI Triple Inhaler and Spacer
  • pMDI Triple Inhaler Only
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Where

9 sites
The Second Affiliated Hospital of Anhui Medical University
Hefei, 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

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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