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

NANot yet recruitingINTERVENTIONAL
Enrollment

380

Participants

Timeline

Start Date

June 20, 2025

Primary Completion Date

April 20, 2026

Study Completion Date

June 20, 2026

Conditions
Asthma, COPD
Interventions
DRUG

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.

DRUG

pMDI Triple Inhaler Only

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.

Trial Locations (8)

Unknown

The Second Affiliated Hospital of Harbin Medical University, Harbin

Anhui Chest Hospital, Hefei

Beilun District Second People's Hospital, Ningbo

Fenghua District People's Hospital, Ningbo

The First Affiliated Hospital of Ningbo University, Ningbo

Xiangshan First People's Hospital Medical and Health Group, Ningbo

Ninghai County First Hospital, Ninghai

Taizhou Municipal Hospital, Taizhou

All Listed Sponsors
lead

First Affiliated Hospital of Ningbo University

NETWORK

NCT07030881 - Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy | Biotech Hunter | Biotech Hunter