An interventional study of pMDI Triple Inhaler and Spacer and pMDI Triple Inhaler Only in Asthma, COPD, sponsored by First Affiliated Hospital of Ningbo University. Recruiting at 9 sites in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by First Affiliated Hospital of Ningbo University · Not applicable, Interventional, and Treatment
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 380 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →First Affiliated Hospital of Ningbo University is the lead sponsor of 26 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
History of any of the following in the past 12 months:
Exclusion Criteria:
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.
Drug: pMDI Triple Inhaler Only
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.
Other: 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.
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.
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.
Time frame: Baseline, 3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: Baseline and 3 months
Plan to share: No
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First Affiliated Hospital of Ningbo University