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NCT Number: NCT07030881

Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy

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.

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Key information

Conditions

Asthma, COPD Asthma Bronchial Diseases Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

pMDI Triple Inhaler and Spacer

Other

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

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Post-Bronchodilator FEV₁ From Baseline to 3 Months

    Time frame: Baseline and 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.

  2. Change in Treatment Adherence Score (MARS Questionnaire) From Baseline to 3 and 6 Months

    Time frame: Baseline, 3 months, 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.

  3. Time to First Moderate-to-Severe Acute Exacerbation

    Time frame: Baseline, 3 months

    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.

  4. Change in Inhalation Technique Score From Baseline to 3 Months

    Time frame: Baseline, 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.

  5. Change in Local Side Effect Score (ICS-Related)

    Time frame: Baseline, 1, 2, 3 months

    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).

  6. Change in Patient Satisfaction Score (VAS)

    Time frame: 3 and 6 months

    A visual analog scale (VAS, range 0-10) will be used to assess satisfaction with the inhalation treatment method. Higher scores indicate greater satisfaction.

  7. Asthma Control Level Based on Four GINA-Recommended Indicators

    Time frame: Baseline and 3 months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Cao

CONTACT

[email protected]

+86-0574-87089878

Shiyi He

CONTACT

[email protected]

+86-0574-87089878

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Ningbo University

Network

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2025
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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