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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Interventions: pMDI Triple Inhaler Only (Device), pMDI Triple Inhaler and Spacer (Device) to pMDI Triple Inhaler Only (Drug), pMDI Triple Inhaler and Spacer (Other)v5
  2. Primary and study completion dates: Jun 20, 2027 to Jun 30, 2027
    • Interventions: pMDI Triple Inhaler Only (Drug), pMDI Triple Inhaler and Spacer (Drug) to pMDI Triple Inhaler Only (Device), pMDI Triple Inhaler and Spacer (Device)
    • Secondary endpoints revised (7)
    v4
  3. Site contacts updated at 4 of 9 sitesv3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Apr 20, 2026 to Jun 20, 2027
    • Study sites: 8 to 9
    • Study completion date: Jun 20, 2026 to Jun 20, 2027
    • Start date changed from estimate of Jun 20, 2025 to Jun 17, 2025
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07030881
Lead Sponsor First Affiliated Hospital of Ningbo University
Conditions
(from sponsor)		 Asthma, COPD
Related terms Asthma, Pulmonary Disease, Chronic Obstructive
Enrollment 380 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov