Asthma, COPDNCT07030881
Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy
A study testing pMDI Triple Inhaler and Spacer and pMDI Triple Inhaler Only in people with Asthma, COPD, run by First Affiliated Hospital of Ningbo University at 9 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Asthma, COPD
- What is being tested?
- pMDI Triple Inhaler and Spacer and pMDI Triple Inhaler Only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 9 sitesChina
- Study dates
- 17 Jun 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥65 years, no gender restriction;
- Confirmed diagnosis of chronic obstructive pulmonary disease (COPD) based on GOLD criteria or bronchial asthma based on GINA criteria;
- Currently on stable treatment with fixed-dose combination ICS/LABA/LAMA via pMDI for ≥4 weeks;
- History of any of the following in the past 12 months:
- ≥1 hospitalization due to exacerbation, or
- ≥2 moderate exacerbations requiring systemic corticosteroids and/or antibiotics;
- Able to complete inhalation technique training and demonstrate basic communication and device-handling abilities;
- Provides written informed consent to participate in the study.
Who cannot join
- Use of other inhalation devices as primary therapy (e.g., DPI, SMI, or nebulizer);
- Regular use of a spacer device for ≥3 weeks within 3 months prior to enrollment;
- Current or recent (within 4 weeks) acute exacerbation not fully resolved;
- Severe cognitive impairment (MMSE score <18);
- Presence of severe systemic comorbidities (e.g., end-stage malignancy, advanced heart failure, hepatic or renal failure);
- Participation in another interventional clinical trial;
- Inability to use a mouthpiece-based spacer (e.g., structural oral/facial abnormalities, severe anxiety);
- Known allergy or hypersensitivity to spacer device materials.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin
Dongju Su, 0451-86605222, hydsdj@126.com
- Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Jing Ye, 0551-63869420, plowchan@126.com
- Recruiting
Anhui Chest Hospital
Hefei
Wenjuan Xia, 0551-63633507, wenjuanx616@163.com
- Recruiting
Beilun District Second People's Hospital
Ningbo
Xiaoyong Huang, 0574-86835539, bldeyy@126.com
- Recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo
Biyun Yu, 0574-55836114, ybyfish@163.com
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo
Chao Cao, 0574-87085151, caocdoctor@163.com
- Recruiting
Ninghai County First Hospital
Ninghai
Min Ji, 0574-65578371, 531668993@qq.com
- Not yet recruiting
Taizhou Central Hospital
Taizhou
Xi Yang, 0576-88526000, yangx0603@tzzxyy.com
- Recruiting
Taizhou Municipal Hospital
Taizhou
Longxiang Li, 0576-88805197, tzmhgcp@163.com
About this study
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
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.
- Conditions
- Asthma, COPD
- Being tested
- pMDI Triple Inhaler and Spacer, pMDI Triple Inhaler Only
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pMDI Triple Inhaler and SpacerOther
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 OnlyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy Group | Active comparator | 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. Receives: Drug: pMDI Triple Inhaler Only |
| Spacer Group | Experimental | 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. Receives: Other: pMDI Triple Inhaler and Spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Moderate-to-Severe Acute Exacerbations Within 3 Months
Moderate exacerbation is defined as a worsening of respiratory symptoms requiring treatment with systemic corticosteroids and/or antibiotics. Severe exacerbation is defined as requiring emergency department visit or hospitalization. All events must be confirmed by the treating physician and recorded in the case report form (CRF). This outcome evaluates whether the use of a valved spacer reduces the rate of such events compared to standard therapy alone.
Measured: Baseline, 3 months
Secondary outcomes (7)
Change in Post-Bronchodilator FEV₁ From Baseline to 3 Months
FEV₁ (forced expiratory volume in 1 second) will be measured using a standardized spirometer following ATS/ERS guidelines. Change will be assessed as both absolute value and percentage improvement. A clinically meaningful improvement is defined as an increase of ≥100 mL or ≥12% from baseline.
Measured: Baseline and 3 months
Change in Treatment Adherence Score (MARS Questionnaire) From Baseline to 3 and 6 Months
The Medication Adherence Report Scale (MARS questionnaire, 10-item version) will be used to assess adherence. The total score ranges from 10 to 50, with higher scores indicating better adherence. Improvement is defined as an increase of ≥3 points from baseline.
Measured: Baseline, 3 months, and 6 months
Time to First Moderate-to-Severe Acute Exacerbation
Time from randomization to first moderate or severe exacerbation will be recorded. Kaplan-Meier survival analysis will be used to compare groups. Events will be defined per GOLD/GINA criteria and confirmed by treating physicians.
Measured: Baseline, 3 months
Change in Inhalation Technique Score From Baseline to 3 Months
Inhalation technique will be scored using a structured checklist (5 items × 5 points, total score 25). Components include device handling, breath-hold, actuation timing and cleaning. Improvement is defined as an increase of ≥5 points.
Measured: Baseline, 3 months
Change in Local Side Effect Score (ICS-Related)
Monthly assessments of local side effects related to ICS will be recorded, including throat irritation, hoarseness, and oral discomfort. Each symptom will be rated on a 0-10 scale (0 = none, 10 = severe).
Measured: Baseline, 1, 2, 3 months
Change in Patient Satisfaction Score (VAS)
A visual analog scale (VAS, range 0-10) will be used to assess satisfaction with the inhalation treatment method. Higher scores indicate greater satisfaction.
Measured: 3 and 6 months
Asthma Control Level Based on Four GINA-Recommended Indicators
For asthma patients, control status will be evaluated based on four criteria: daytime symptoms >2/week, nighttime awakening, reliever use >2/week, and activity limitation. Control will be categorized as: well-controlled (0), partly controlled (1-2), or uncontrolled (≥3).
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start17 Jun 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Ningbo University
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Chao Cao, Ph.D., First Affiliated Hospital of Ningbo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030881
- Sponsor's protocol ID
- 2025-146A-01
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07030881
- Acronym / sponsor ID
- 2025-146A-01
- Conditions
- Asthma, COPD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Ningbo UniversityResearch network
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy Group | Active comparator | Drug: pMDI Triple Inhaler OnlyParticipants 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. |
| Spacer Group | Experimental | Other: pMDI Triple Inhaler and SpacerParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Age ≥65 years, no gender restriction;
- Confirmed diagnosis of chronic obstructive pulmonary disease (COPD) based on GOLD criteria or bronchial asthma based on GINA criteria;
- Currently on stable treatment with fixed-dose combination ICS/LABA/LAMA via pMDI for ≥4 weeks;
- History of any of the following in the past 12 months:
- Able to complete inhalation technique training and demonstrate basic communication and device-handling abilities;
Key exclusion criteria (8 listed)
- Use of other inhalation devices as primary therapy (e.g., DPI, SMI, or nebulizer);
- Regular use of a spacer device for ≥3 weeks within 3 months prior to enrollment;
- Current or recent (within 4 weeks) acute exacerbation not fully resolved;
- Severe cognitive impairment (MMSE score <18);
- Presence of severe systemic comorbidities (e.g., end-stage malignancy, advanced heart failure, hepatic or renal failure);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pMDI Triple Inhaler and SpacerParticipants 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. | Other | Spacer Group |
| pMDI Triple Inhaler OnlyParticipants 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. | Drug | Standard Therapy Group |
Primary outcome
Incidence of Moderate-to-Severe Acute Exacerbations Within 3 Months
Time frame: Baseline, 3 months
Moderate exacerbation is defined as a worsening of respiratory symptoms requiring treatment with systemic corticosteroids and/or antibiotics. Severe exacerbation is defined as requiring emergency department visit or hospitalization. All events must be confirmed by the treating physician and recorded in the case report form (CRF). This outcome evaluates whether the use of a valved spacer reduces the rate of such events compared to standard therapy alone.
7 secondary outcomes
Change in Post-Bronchodilator FEV₁ From Baseline to 3 Months
Time frame: Baseline and 3 months
Change in Treatment Adherence Score (MARS Questionnaire) From Baseline to 3 and 6 Months
Time frame: Baseline, 3 months, and 6 months
Time to First Moderate-to-Severe Acute Exacerbation
Time frame: Baseline, 3 months
Change in Inhalation Technique Score From Baseline to 3 Months
Time frame: Baseline, 3 months
Change in Local Side Effect Score (ICS-Related)
Time frame: Baseline, 1, 2, 3 months
Change in Patient Satisfaction Score (VAS)
Time frame: 3 and 6 months
Asthma Control Level Based on Four GINA-Recommended Indicators
Time frame: Baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pMDI Triple Inhaler and Spacer and pMDI Triple Inhaler Only in people with Asthma, COPD, run by First Affiliated Hospital of Ningbo University at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Cao (+86-0574-87089878, caocdoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Moderate-to-Severe Acute Exacerbations Within 3 Months (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.