Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy
NCT ID: NCT07030881
Last Updated: 2025-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
380 participants
INTERVENTIONAL
2025-06-20
2026-06-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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-care for stable, high-risk COPD or asthma patients as per GOLD and GINA guidelines.
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.
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 intervention aims to optimize inhalation technique, improve treatment adherence, and potentially reduce the incidence of moderate-to-severe exacerbations.
Interventions
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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 intervention aims to optimize inhalation technique, improve treatment adherence, and potentially reduce the incidence of moderate-to-severe exacerbations.
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-care for stable, high-risk COPD or asthma patients as per GOLD and GINA guidelines.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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First Affiliated Hospital of Ningbo University
NETWORK
Responsible Party
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Caochao
Principal Investigator
Locations
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The Second Affiliated Hospital of Harbin Medical University
Harbin, , China
Anhui Chest Hospital
Hefei, , China
Beilun District Second People's Hospital
Ningbo, , China
Fenghua District People's Hospital
Ningbo, , China
The First Affiliated Hospital of Ningbo University
Ningbo, , China
Xiangshan First People's Hospital Medical and Health Group
Ningbo, , China
Ninghai County First Hospital
Ninghai, , China
Taizhou Municipal Hospital
Taizhou, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-146A-01
Identifier Type: -
Identifier Source: org_study_id
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