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Active, Not Recruiting

NCT Number: NCT05366309

Performance and Adherence in Children Using Spacers

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Robert James Bowler

Stoke-on-Trent, Staffordshire, ST44JJ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tailored education

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.

Standard care education

Other

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

Primary outcomes

  1. Overall adherence to inhaled treatment (the product of persistence (number of doses taken as prescribed) and technique)

    Time frame: From recruitment up until 12-16 weeks follow-up time point

    Overall adherence

Secondary outcomes

  1. The proportion of children and young people with asthma who are eligible for participation within the study from secondary care via screening logs

    Time frame: From recruitment up until 12-16 weeks follow-up time point

    Proportion eligible

  2. Recruitment and attrition rates over the study via screening and enrolment logs

    Time frame: From recruitment up until 12-16 weeks follow-up time point

    Recruitment and attrition

  3. The success rate of obtaining data from the Smart spacer device

    Time frame: From recruitment up until 12-16 weeks follow-up time point

    Success rate

  4. Feedback from System Usability Score (SUS)

    Time frame: At 12-16 weeks follow-up time point

    SUS

  5. Feedback from Net Promoter Score (NPS)

    Time frame: At 12-16 weeks follow-up time point

    NPS

  6. Rate of device failure from any cause (including loss of device, inability to retrieve data from SD card)

    Time frame: From recruitment to 12-16 weeks follow-up time point

    Device failure

  7. Asthma control test (ACT) or Childhood Asthma Control Test (c-ACT)

    Time frame: From recruitment to 12-16 weeks follow-up time point

    ACT

  8. Asthma Control Questionnaire

    Time frame: From recruitment to 12-16 weeks follow-up time point

    ACQ

  9. GINA control score

    Time frame: From recruitment to 12-16 weeks follow-up time point

    GINA

  10. Salbutamol (rescue) use

    Time frame: From recruitment to 12-16 weeks follow-up time point

    Salbutamol use

  11. Need for oral steroid burst

    Time frame: From recruitment to 12-16 weeks follow-up time point

    Oral steroid burst use

  12. m-PAQLQ score

    Time frame: From recruitment to 12-16 weeks follow-up time point

    m-PAQLQ

  13. FEV1 z score

    Time frame: From recruitment to 12-16 weeks follow-up time point

    FEV1 z

  14. FeNO (ppb)

    Time frame: From recruitment to 12-16 weeks follow-up time point

    FeNO (ppb)

  15. UKIG score

    Time frame: From recruitment to 12-16 weeks follow-up time point

    UKIG

Sponsors and collaborators

Lead sponsor

University Hospitals of North Midlands NHS Trust

Other

Registry information

Official study title

OUtcome Following Tailored Education and Retraining: Studying Performance and Adherence in ChildrEn and Young People With Asthma: a Randomised Feasibility Study

Acronym: OUTER-SPACERS

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 9, 2022
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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