Clinical Trial

Performance and Adherence in Children Using Spacers

Study acronym: OUTER-SPACERS
Active, Not Recruiting
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Summary
Asthma is a common disease which causes swelling in the airways, making it difficult to breathe. Asthma is common in children, affecting 1 in 11 children in the UK. Asthma is treated with inhalers which reduce the swelling. If inhalers are taken correctly they can help keep symptoms under control, allowing asthma sufferers to go about their day with less chance of having an asthma attack. Many patients have been found to not take their inhalers correctly and either under use (which leads to poor control of symptoms) or over use (which leads to potential side effects). Although asthma in most patients can be controlled with inhalers, not using inhalers correctly is one of the most common causes of poor control. This is common in children and young people (CYP) with all severities of asthma, resulting in high burden on the families and healthcare systems. The biggest challenge facing doctors and nurses helping CYP with asthma is finding a way to ensure that they take the medication. Whilst there are many studies looking into inhaler use, there are no large studies about how inhalers are used between clinic visits in CYP with asthma. The Smart Spacer is monitoring device which allows doctors to monitor when and how effectively inhalers are being used. This study wants to find out how well this device works, how well and how often CYP are using their inhalers, and if tailored education improves asthma control. To do this, participants in the study will be randomly selected to have "tailored education" or "standard care education". The investigators are inviting 100 children and young people (CYP) aged 6-18 years who have asthma to join this study.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-05-04; most recent amendment 2026-03-25.
Status change: Recruiting → Active, Not Recruiting 2026-03-25
Status change: Not Yet Recruiting → Recruiting 2023-05-10
Trial Details
NCT Number NCT05366309
Lead Sponsor University Hospitals of North Midlands NHS Trust
Conditions Asthma, Asthma in Children
Enrollment 43 participants
Start Date 2022-09-01
Primary Completion 2025-07-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-30