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

NCT07030881 | Not Yet Recruiting

• 1 other identifier: 2025-146A-01
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 8

Brief 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. High-risk is defined as ≥1 hospitalization or ≥2 moderate exacerbations in the past 12 months. 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.

Conditions

Asthma, COPD

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3 months

Secondary Outcomes (7)

• Change in Post-Bronchodilator FEV₁ From Baseline to 3 Months

  Baseline and 3 months

• Change in Treatment Adherence Score (MARS-5) From Baseline to 3 and 6 Months

  Baseline, 3 months, and 6 months

• Time to First Moderate-to-Severe Acute Exacerbation

  Baseline, 3 months

• Change in Inhalation Technique Score From Baseline to 3 Months

  Baseline, 3 months

• Change in Local Side Effect Score (ICS-Related)

  Baseline, 1, 2, 3 months

Study Arms (2)

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.

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.

Drug: pMDI Triple Inhaler and Spacer

Interventions

pMDI Triple Inhaler and Spacer DRUG

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.

Spacer Group

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.

Standard Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Ningbo University: lead

Study Sites (8)

The Second Affiliated Hospital of Harbin Medical University

Harbin, China

Location

Anhui Chest Hospital

Hefei, China

Location

Beilun District Second People's Hospital

Ningbo, China

Location

Fenghua District People's Hospital

Ningbo, China

Location

The First Affiliated Hospital of Ningbo University

Ningbo, China

Location

Xiangshan First People's Hospital Medical and Health Group

Ningbo, China

Location

Ninghai County First Hospital

Ninghai, China

Location

Taizhou Municipal Hospital

Taizhou, China

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Interventions

Metered Dose Inhalers

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nebulizers and Vaporizers; Equipment and Supplies

Central Study Contacts

Chao Cao

CONTACT

+86-0574-87089878; caocdoctor@163.com

Shiyi He

CONTACT

+86-0574-87089878; shiyihii@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: June 20, 2025
• Primary Completion: April 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)