RecruitingRecruiting
Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy
NCT07030881 · First Affiliated Hospital of Ningbo University
In plain English
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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
About this study
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.
Eligibility criteria
Inclusion Criteria:
1. Age ≥65 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 ≥4 weeks;
4. History of any of the following in the past 12 months:
1. ≥1 hospitalization due to exacerbation, or
2. ≥2 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 ≥3 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.
Study design
Enrollment target: 380 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-06-17
Estimated completion: 2027-06-20
Last updated: 2026-04-06
Interventions
Drug: pMDI Triple Inhaler and SpacerDrug: pMDI Triple Inhaler Only
Primary outcomes
- • Incidence of Moderate-to-Severe Acute Exacerbations Within 3 Months (Baseline, 3 months)
Sponsor
First Affiliated Hospital of Ningbo University · network
Contacts & investigators
ContactChao Cao · contact · caocdoctor@163.com · +86-0574-87089878
ContactShiyi He · contact · shiyihii@163.com · +86-0574-87089878
All locations (9)
The Second Affiliated Hospital of Anhui Medical UniversityRecruiting
Hefei, Anhui, China
The Second Affiliated Hospital of Harbin Medical UniversityRecruiting
Harbin, China
Anhui Chest HospitalRecruiting
Hefei, China
Beilun District Second People's HospitalRecruiting
Ningbo, China
Ningbo Medical Center Lihuili HospitalRecruiting
Ningbo, China
The First Affiliated Hospital of Ningbo UniversityRecruiting
Ningbo, China
Ninghai County First HospitalRecruiting
Ninghai, China
Taizhou Central HospitalNot Yet Recruiting
Taizhou, China
Taizhou Municipal HospitalRecruiting
Taizhou, China