Simple spacer could cut hospital visits for seniors with lung disease
NCT ID NCT07030881
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a spacer device to standard triple inhaler therapy can reduce serious flare-ups in older adults (65+) with asthma or COPD who are at high risk. 380 participants will either use the spacer with their inhaler or stick with the inhaler alone. The goal is to see if the spacer improves drug delivery and lowers the chance of needing emergency care or hospitalization.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- valved spacer device used with triple inhaled therapy (ICS/LABA/LAMA)
- What this could lead to
- If it works, this could offer a simple, low-cost way to reduce serious flare-ups and hospital visits in older adults with asthma or COPD.
- What could go wrong
- This is an early-stage trial with only 380 participants, and the open-label design may introduce bias. The spacer may not significantly reduce exacerbations, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 380 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Anhui Chest Hospital
RECRUITINGHefei, China
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Beilun District Second People's Hospital
RECRUITINGNingbo, China
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Ningbo Medical Center Lihuili Hospital
RECRUITINGNingbo, China
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Ninghai County First Hospital
RECRUITINGNinghai, China
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Taizhou Central Hospital
NOT_YET_RECRUITINGTaizhou, China
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Taizhou Municipal Hospital
RECRUITINGTaizhou, China
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The First Affiliated Hospital of Ningbo University
RECRUITINGNingbo, China
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The Second Affiliated Hospital of Anhui Medical University
RECRUITINGHefei, Anhui, China
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The Second Affiliated Hospital of Harbin Medical University
RECRUITINGHarbin, China
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