AsthmaCHAMPIONSNCT02913872
Childhood Asthma Management in Primary Care: Implementation Of Exhaled Nitric Oxide and Spirometry Testing
An observational study of Asthma, run by University of Leicester at 2 sites in United Kingdom.
Trial summary
What are the capacity and training needs in general practice to implement routine spirometry and eNO testing in children aged 5-16 years? Asthma is the commonest long-term disease of childhood in the United Kingdom (UK). Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Asthma
- How many people
- 613 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Jun 2016to 1 Sep 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients registered to participating general practices in Leicestershire and Northamptonshire
Who may be able to join
- On the practice asthma register or
- Are prescribed regular (on repeat prescription) inhaled corticosteroids including beclometasone, fluticasone and budesonide and also search specifically for 'brands' that are commonly prescribed to include 'clenil', 'seretide', 'symbicort', and 'qvar' or
- Have been prescribed ≥ 2 Salbutamol MDI's in the last 12 months or
- Had a documented exacerbation of asthma in the last 12 months
- Able and willing, in the opinion of the Investigator, to give informed consent
Who cannot join
- Children who are unable to perform lung function tests for any reason
- Children and young people <5 years and >16 years
- Unable or unwilling, in the opinion of the Investigator, to give informed consent
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Lakeside Surgery
Corby, Northamptonshire, NN17 2UR
Countesthorpe Health Centre
Leicester, Leicestershire, LE8 5QJ
About this study
What are the capacity and training needs in general practice to implement routine spirometry and eNO testing in children aged 5-16 years?
Asthma is the commonest long-term disease of childhood in the United Kingdom (UK). Under-diagnosis and under-treatment of childhood asthma in general practice (GP) have been reported from several European countries including the UK. This can result in poor symptom control and increased risk of asthma related deaths.
Read more
It has been suggested that both under- and over- diagnosis of childhood asthma in general practice could be improved by routinely using objective lung function testing for diagnosis and monitoring.
The proposed objective lung function tests (spirometry and exhaled nitric oxide measurements - eNO) are already used routinely in UK hospitals, but are not usually available in general practice where most children are cared for.
Why is it important? - Availability of these tests will help health professionals in general practice to look after children with asthma better, and hopefully improve asthma control.
What will this study achieve? - Though it is believed that providing spirometry and eNO in general practice would be beneficial, there is little data on how this can be achieved. This study will employ both qualitative and quantitative measures in order to evaluate the resources required to implement routine spirometry and eNO testing for children in primary care; and to investigate the impact this would have on diagnosis in children with suspected asthma.
How? - The investigators will work with general practices in and around Leicestershire, UK. Firstly, to identify what the barriers are to implementing these tests, and secondly to train the practices to perform and interpret spirometry and eNO independently in children.
Children with suspected or previously diagnosed asthma will be invited for review and lung function testing. The investigators will record the time it takes to train general practices to perform and interpret spirometry and eNO independently, and the additional clinic capacity required to provide these tests.
- Conditions
- Asthma
- Keywords
- Spirometry, Exhaled Nitric Oxide, Primary Care
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Needed to Perform Paediatric Spirometry and eNO Testing in General Practice
Time (minutes) to perform both spirometry and eNO test in children
Measured: 12 months
Number of Children in Whom Usable Spirometry and eNO Data Can be Obtained
Number of children (out of 612) able to perform objective tests
Measured: 12 months
Secondary outcomes (3)
The Number of Children in Whom a Diagnosis of Asthma Can be Confirmed Using Spirometry and eNO Testing
Number of children in whom an asthma diagnosis could be confirmed on objective testing
Measured: 12 months
Change in Paediatric Asthma Quality of Life Questionnaire Score Measured at Enrolment and 3-6 Months Post-enrollment
Timepoints - Assessed at enrolment and at 3-6 months post enrolment Purpose: The Paediatric Asthma Quality of Life Questionnaire (PAQLQ) was developed to measure the functional problems (physical, emotional and social) that are most troublesome to children with asthma.
Format: The PAQLQ can be administered by an interviewer or self-administered by the child Content: The PAQLQ contains 23 questions that cover three domains: activity limitation, symptoms, and emotional function Scoring: Children are asked to think about how they have been during the previous week and to respond to each of the 32 questions on a 7-point scale (7 = not bothered at all -
1 = extremely bothered). The overall PAQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains. A change in score greater than 0.5 on the 7-point scale can be considered clinically important.
Measured: PAQLQ score was assessed at enrolment and then again at 3-6 months post enrolment
Change in Child Health Utility 9D Questionnaire Score Measured at Enrolment and at 3-6 Months Post-enrolment
Timepoints - measured at enrolment and at 3-6 months post-enrolment Purpose: The CHU9D is a paediatric generic preference based measure of health related quality of life. It consists of a descriptive system and a set of preference weights, giving utility values for each health state described by the descriptive system, allowing the calculation of quality adjusted life years (QALYs) for use in cost utility analysis.
Format: Consists of nine dimensions of health-related quality of life, including worry, sadness, pain, tiredness, annoyance, school, sleep, daily routine, and activities. The child completes the questionnaire, or a proxy can complete it for younger children Scoring: Scores can range from -0.1059 (min) to 1 (max); with a score of 1 indicating a "state of perfect health", and a lower score indicating worse health. A minimally important difference (MID) of 0.03 is used to assess the magnitude of mean difference when comparing CHU9D scores.
Measured: CHU9D score was assessed at enrolment and then again at 3-6 months post-enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start1 Jun 2016
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 613 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Aerocrine AB
- Responsible party
- Sponsor
- Investigators
- Erol Gaillard, PhD MRCPCH, Principal investigator, National Institute for Health Research, Leicester Respiratory Biomedical Research Unit, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913872
- Sponsor's protocol ID
- 0566
- Acronym
- CHAMPIONS
- Status last verified
- Jan 2025
- First submitted
- 9 Sep 2016
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Asthma Management in Primary Care: Implementation Of Exhaled Nitric Oxide and Spirometry Testing
- ClinicalTrials.gov ID
- NCT02913872
- Acronym / sponsor ID
- CHAMPIONS / 0566
- Conditions
- Asthma
- Keywords
- Spirometry, Exhaled Nitric Oxide, Primary Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 613 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- Aerocrine AB
- Study start
- 1 Jun 2016
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
What are the capacity and training needs in general practice to implement routine spirometry and eNO testing in children aged 5-16 years?
Asthma is the commonest long-term disease of childhood in the United Kingdom (UK). Under-diagnosis and under-treatment of childhood asthma in general practice (GP) have been reported from several European countries including the UK. This can result in poor symptom control and increased risk of asthma related deaths.
It has been suggested that both under- and over- diagnosis of childhood asthma in general practice could be improved by routinely using objective lung function testing for diagnosis and monitoring.
The proposed objective lung function tests (spirometry and exhaled nitric oxide measurements - eNO) are already used routinely in UK hospitals, but are not usually available in general practice where most children are cared for.
Why is it important? - Availability of these tests will help health professionals in general practice to look after children with asthma better, and hopefully improve asthma control.
What will this study achieve? - Though it is believed that providing spirometry and eNO in general practice would be beneficial, there is little data on how this can be achieved. This study will employ both qualitative and quantitative measures in order to evaluate the resources required to implement routine spirometry and eNO testing for children in primary care; and to investigate the impact this would have on diagnosis in children with suspected asthma.
How? - The investigators will work with general practices in and around Leicestershire, UK. Firstly, to identify what the barriers are to implementing these tests, and secondly to train the practices to perform and interpret spirometry and eNO independently in children.
Children with suspected or previously diagnosed asthma will be invited for review and lung function testing. The investigators will record the time it takes to train general practices to perform and interpret spirometry and eNO independently, and the additional clinic capacity required to provide these tests.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients registered to participating general practices in Leicestershire and Northamptonshire
Key inclusion criteria (5 listed)
- On the practice asthma register or
- Are prescribed regular (on repeat prescription) inhaled corticosteroids including beclometasone, fluticasone and budesonide and also search specifically for 'brands' that are commonly prescribed to include 'clenil', 'seretide', 'symbicort', and 'qvar' or
- Have been prescribed ≥ 2 Salbutamol MDI's in the last 12 months or
- Had a documented exacerbation of asthma in the last 12 months
- Able and willing, in the opinion of the Investigator, to give informed consent
Key exclusion criteria (3 listed)
- Children who are unable to perform lung function tests for any reason
- Children and young people <5 years and >16 years
- Unable or unwilling, in the opinion of the Investigator, to give 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.
Primary outcome
Time Needed to Perform Paediatric Spirometry and eNO Testing in General Practice
Time frame: 12 months
Time (minutes) to perform both spirometry and eNO test in children
Number of Children in Whom Usable Spirometry and eNO Data Can be Obtained
Time frame: 12 months
Number of children (out of 612) able to perform objective tests
3 secondary outcomes
The Number of Children in Whom a Diagnosis of Asthma Can be Confirmed Using Spirometry and eNO Testing
Time frame: 12 months
Change in Paediatric Asthma Quality of Life Questionnaire Score Measured at Enrolment and 3-6 Months Post-enrollment
Time frame: PAQLQ score was assessed at enrolment and then again at 3-6 months post enrolment
Change in Child Health Utility 9D Questionnaire Score Measured at Enrolment and at 3-6 Months Post-enrolment
Time frame: CHU9D score was assessed at enrolment and then again at 3-6 months post-enrolment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Erol Gaillard, PhD MRCPCH principal investigator
National Institute for Health Research, Leicester Respiratory Biomedical Research Unit, University of Leicester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University of Leicester at 2 sites 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 5 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: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time Needed to Perform Paediatric Spirometry and eNO Testing in General Practice (time frame: 12 months). The study lists 2 primary outcomes in all. 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 3 Feb 2025.