AsthmaOUTER-SPACERSNCT05366309
Performance and Adherence in Children Using Spacers
A study testing Tailored education in people with Asthma and Asthma in Children, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Asthma, Asthma in Children
- What is being tested?
- Tailored education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Robert James Bowler
Stoke-on-Trent, Staffordshire, ST44JJ
About this study
Official title: OUtcome Following Tailored Education and Retraining: Studying Performance and Adherence in ChildrEn and Young People With Asthma: a Randomised Feasibility Study
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.
Read more
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
- Being tested
- Tailored education, Standard care education
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored educationOther
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 educationOther
Participants randomised to this group will receive usual care in terms of their education.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care (Control) Group | Active comparator | Participants randomised to this group will receive usual care in terms of their education. Receives: Other: Standard care education |
| Tailored Education Group | Experimental | Participants randomised to this group will receive tailored education, which is additional to standard care. Receives: Other: Tailored education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall adherence to inhaled treatment (the product of persistence (number of doses taken as prescribed) and technique)
Overall adherence
Measured: From recruitment up until 12-16 weeks follow-up time point
Secondary outcomes (15)
The proportion of children and young people with asthma who are eligible for participation within the study from secondary care via screening logs
Proportion eligible
Measured: From recruitment up until 12-16 weeks follow-up time point
Recruitment and attrition rates over the study via screening and enrolment logs
Recruitment and attrition
Measured: From recruitment up until 12-16 weeks follow-up time point
The success rate of obtaining data from the Smart spacer device
Success rate
Measured: From recruitment up until 12-16 weeks follow-up time point
Feedback from System Usability Score (SUS)
SUS
Measured: At 12-16 weeks follow-up time point
Feedback from Net Promoter Score (NPS)
NPS
Measured: At 12-16 weeks follow-up time point
Rate of device failure from any cause (including loss of device, inability to retrieve data from SD card)
Device failure
Measured: From recruitment to 12-16 weeks follow-up time point
Asthma control test (ACT) or Childhood Asthma Control Test (c-ACT)
ACT
Measured: From recruitment to 12-16 weeks follow-up time point
Asthma Control Questionnaire
ACQ
Measured: From recruitment to 12-16 weeks follow-up time point
GINA control score
GINA
Measured: From recruitment to 12-16 weeks follow-up time point
Salbutamol (rescue) use
Salbutamol use
Measured: From recruitment to 12-16 weeks follow-up time point
Need for oral steroid burst
Oral steroid burst use
Measured: From recruitment to 12-16 weeks follow-up time point
m-PAQLQ score
m-PAQLQ
Measured: From recruitment to 12-16 weeks follow-up time point
FEV1 z score
FEV1 z
Measured: From recruitment to 12-16 weeks follow-up time point
FeNO (ppb)
FeNO (ppb)
Measured: From recruitment to 12-16 weeks follow-up time point
UKIG score
UKIG
Measured: From recruitment to 12-16 weeks follow-up time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Sep 2022
- Primary completion31 Jul 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Will Carroll, Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366309
- Sponsor's protocol ID
- 3022
- Acronym
- OUTER-SPACERS
- Status last verified
- Mar 2026
- First submitted
- 20 Apr 2022
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OUtcome Following Tailored Education and Retraining: Studying Performance and Adherence in ChildrEn and Young People With Asthma: a Randomised Feasibility Study
- ClinicalTrials.gov ID
- NCT05366309
- Acronym / sponsor ID
- OUTER-SPACERS / 3022
- Conditions
- Asthma, Asthma in Children
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospitals of North Midlands NHS TrustUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care (Control) Group | Active comparator | Other: Standard care educationParticipants randomised to this group will receive usual care in terms of their education. |
| Tailored Education Group | Experimental | Other: Tailored educationParticipants randomised to this group will receive tailored education, which is additional to standard care. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored educationTailored 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. | Other | Tailored Education Group |
| Standard care educationParticipants randomised to this group will receive usual care in terms of their education. | Other | Standard Care (Control) Group |
Primary outcome
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
15 secondary outcomes
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
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
The success rate of obtaining data from the Smart spacer device
Time frame: From recruitment up until 12-16 weeks follow-up time point
Feedback from System Usability Score (SUS)
Time frame: At 12-16 weeks follow-up time point
Feedback from Net Promoter Score (NPS)
Time frame: At 12-16 weeks follow-up time point
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
Asthma control test (ACT) or Childhood Asthma Control Test (c-ACT)
Time frame: From recruitment to 12-16 weeks follow-up time point
Asthma Control Questionnaire
Time frame: From recruitment to 12-16 weeks follow-up time point
GINA control score
Time frame: From recruitment to 12-16 weeks follow-up time point
Salbutamol (rescue) use
Time frame: From recruitment to 12-16 weeks follow-up time point
Need for oral steroid burst
Time frame: From recruitment to 12-16 weeks follow-up time point
m-PAQLQ score
Time frame: From recruitment to 12-16 weeks follow-up time point
FEV1 z score
Time frame: From recruitment to 12-16 weeks follow-up time point
FeNO (ppb)
Time frame: From recruitment to 12-16 weeks follow-up time point
UKIG score
Time frame: From recruitment to 12-16 weeks follow-up time point
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Will Carroll principal investigator
PI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored education in people with Asthma and Asthma in Children, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.