380
Participants
Start Date
June 20, 2025
Primary Completion Date
April 20, 2026
Study Completion Date
June 20, 2026
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.
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.
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
First Affiliated Hospital of Ningbo University
NETWORK