NCT05366309Active, not recruiting
Performance and Adherence in Children Using Spacers
OUtcome Following Tailored Education and Retraining: Studying Performance and Adherence in ChildrEn and Young People With Asthma: a Randomised Feasibility Study
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 20 Apr 2022
- Start date
- 1 Sept 2022
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Diseases
- Asthma
- NCT number
- NCT05366309
What you commit to
- Study type: Interventional
- Participants enrolled: 43
- From 1 Sept 2022 to the primary completion date, 31 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Significant co-existing respiratory disease (e.g. cystic fibrosis);
Other
- Currently participating in another clinical trial of an investigational medicinal product or medical device;
- Non-English speaker where translation facilities are insufficient to guarantee informed consent.
Who the study is looking for
- Aged 6-18 years;
- Attending secondary care with a diagnosis of asthma;
- Willing and able to give fully informed consent, or, participants having an acceptable individual capable of giving consent on the participant's behalf (e.g. parent or guardian of a child under 16 years of age);
- Able to perform lung function and exhaled nitric oxide measurements;
- Take twice-daily preventer medication using a valved holding chamber (spacer device) i.e. inhaled corticosteroid with or without long-acting beta antagonist;
- Willing and able to comply with the study procedures.
Age in the registry: 6 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Robert James Bowler Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.