Performance and Adherence in Children Using Spacers

NCT ID: NCT05366309

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Asthma; Asthma in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard Care (Control) Group

Participants randomised to this group will receive usual care in terms of their education.

Group Type: ACTIVE_COMPARATOR

Standard care education

Intervention Type: OTHER

Participants randomised to this group will receive usual care in terms of their education.

Tailored Education Group

Participants randomised to this group will receive tailored education, which is additional to standard care.

Group Type: EXPERIMENTAL

Tailored education

Intervention Type: OTHER

Tailored Education: A delegated investigator will review the SD memory card data and share the results with the participant and/or parent/guardian. The investigator will explain whether there are partial or critical errors to inhalation technique that have been recorded. The participant will be informed about their overall adherence; including how and when they used their asthma medications. If errors in medication use are identified, specific coaching will be provided to help eliminate errors.

Interventions

Tailored education

Tailored Education: A delegated investigator will review the SD memory card data and share the results with the participant and/or parent/guardian. The investigator will explain whether there are partial or critical errors to inhalation technique that have been recorded. The participant will be informed about their overall adherence; including how and when they used their asthma medications. If errors in medication use are identified, specific coaching will be provided to help eliminate errors.

Intervention Type: OTHER

Standard care education

Participants randomised to this group will receive usual care in terms of their education.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Significant co-existing respiratory disease (e.g. cystic fibrosis);
• 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals of North Midlands NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Will Carroll

Role: PRINCIPAL_INVESTIGATOR

PI

Locations

Robert James Bowler

Stoke-on-Trent, Staffordshire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Robert Bowler

Role: CONTACT

robert.bowler@uhnm.nhs.uk

01782 ext. 671939

Keira Watts

Role: CONTACT

Keira.Watts@uhnm.nhs.uk

01782 ext. 671939

Facility Contacts

Robert J Bowler

Role: primary

Robert.Bowler@uhnm.nhs.uk

+447592800964

Other Identifiers

3022

Identifier Type: -

Identifier Source: org_study_id