Asthma ChildhoodNCT07643753
Active Airways for Children and Young People With Asthma
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION and education in people with Asthma Childhood and Exercise, run by University of Leicester at 1 site in United Kingdom.
Trial summary
What is this study about? The investigators want to see if exercise and education sessions can help children and young people (aged 10-17) with asthma, manage the participants asthma better. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Asthma Childhood, Exercise, Children
- What is being tested?
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION and education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2026to Sep 2030
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Willing and able to consent to participate in the trial
- Able to understand written and spoken English
- A diagnosis of Mild to Moderate Asthma or Severe Asthma based on the European Respiratory Society (ERS)/ American Thoracic Society (ATS) consensus statement on Severe Asthma
- Able to participate in a formal exercise programme
- Aged 10-17 years
- Able to engage in focus groups
- Approximately 130cm tall (to be able to complete cardiopulmonary exercise testing (CPET))
Who cannot join
- Self-reported uncontrolled severe exercise-induced breathlessness
- Required a course of antibiotics or oral corticosteroids within the 4 weeks prior to the study commencing
- Children with severe co-morbidities that will not allow them to participate in an exercise programme e.g. Severe neuromuscular disorders, recent fractures or surgeries, cognitive or behavioural conditions.
- Participant is unable or unwilling, in the opinion of the investigator, to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
University of Leicester
Leicester
Naomi Dayman, 07487506547, nad21@leicester.ac.uk
About this study
Official title: The Feasibility of an Exercise and Asthma Educational Programme 'Active Airways' on Health Outcomes in Children and Young People With Asthma With All Severities
What is this study about? The investigators want to see if exercise and education sessions can help children and young people (aged 10-17) with asthma, manage the participants asthma better.
The investigators will place participants that are recruited to this study into one of three groups by a computer (randomly):
Group 1:
Usual Care: Continue with normal asthma treatment.
Group 2:
Education: Usual care + a 45-minute online asthma education class once a week.
Group 3:
Exercise \& Education: Usual care + 3 exercise sessions a week and asthma education classes.
Read the detailed description
This research aims to identify if an exercise and/or asthma education programme, called 'Active Airways', is feasible and acceptable in the paediatric asthma patient. Feasibility, the primary outcome of this study, will be evaluated by calculating the percentage of people approached who participate in the intervention (recruitment) and the percentage who complete the intervention (retention and adherence). The investigators also want to see if the Active Airways programme could improve cardiorespiratory fitness, quality of life and lung function, reduce asthma attacks and reduce healthcare use.
- Conditions
- Asthma Childhood, Exercise, Children
- Being tested
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION, education
- Keywords
- asthma, children, exercise, physical activity
- Medical subject headings
- Motor Activity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE TRAINING WITH OR WITHOUT MEDICATIONOther
Also called exercise
12 week interval exercise training programme and 12 week education on exercise with asthma
educationOther
education on exercise and asthma
| Study group | Role | What they receive |
|---|---|---|
| Group 1- usual care | No intervention | Participants will continue to receive usual care from their asthma team/ provider |
| Group 2- education | Active comparator | Participants will receive a 12 week education class on exercise Receives: Other: education |
| Group 3- exercise | Active comparator | Participants will take part in a 12 week interval exercise class Receives: Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION; Other: education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
The percentage of children approached who participate in the intervention (recruitment)
Measured: 12 weeks
Retention
The percentage of participants that complete the intervention with a retention rate of >70%
Measured: 12 weeks
Secondary outcomes (10)
Adherence to programme
Participant engagement measured through attendance rates.
Measured: 12 weeks
Wrist worn accelerometers
Device wear time compliance during the 12-week study, aiming for =>10 hours a day
Measured: 12 weeks
Focus groups on patients experience to barriers to an exercise programme
Lived experience of the barriers for children with asthma to taking part in an exercise programme, measured through qualitative focus groups.
Measured: 12 weeks
Health beliefs
Baseline demographics from participants will be recorded from medical records
Measured: 12 weeks
Respiratory (throat) samples
Throat samples will be taken and microbial analysis for assessing microbial diversity through 16S rRNA sequencing, to provide relative abundance of bacterial groups. A greater bacterial diversity in the respiratory sample is considered a sign of heathier and more resilient microbial community. This could lead to fewer asthma exacerbations and better asthma control.
Measured: Baseline, 12 weeks, 6 months and 1 year.
Quality of life of participants using the paeditric quality of life inventory (asthma module)
Measured through the paediatric quality of life asthma module to measure how asthma affects the health-related quality of life using 28 items divided into 4 domains, higher scores mean better quality of life and lower scores mean greater asthma-related impairment.
Measured: Baseline, 12 weeks, 6 months and 1 year
Effectiveness of the programme
Cardiorespiratory fitness (maximal oxygen uptake measured by VO2 max)
Measured: Baseline, 12 weeks, 6 months and 1 year.
Respiratory (nasal) samples
Nasal samples will be taken and microbial analysis for assessing microbial diversity through 16S rRNA sequencing, to provide relative abundance of bacterial groups. A greater bacterial diversity in the respiratory sample is considered a sign of a heathier and more resilient microbial community. This could lead to fewer asthma exacerbations and better asthma control.
Measured: Baseline, 12 weeks, 6 months and 1 year.
Gut samples
Stool samples will be taken and microbial analysis for assessing microbial diversity through 16S rRNA sequencing, to provide relative abundance of bacterial groups. A greater bacterial diversity in the stool sample is considered a sign of heathier and more resilient microbial community which could lead to fewer asthma exacerbations and better asthma control.
Measured: Baseline, 12 weeks, 6 months and 1 year.
Focus groups on motivators for an exercise programme
Lived experience of the motivators for children and young people with asthma to taking part in an exercise programme, measured through qualitative focus groups.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma ChildhoodStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are three groups for the active airways study: Group 1- usual care Group 2- education only Group 3- exercise and education programme
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor
- Investigators
- Erol Gaillard, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643753
- Sponsor's protocol ID
- 1068
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of an Exercise and Asthma Educational Programme 'Active Airways' on Health Outcomes in Children and Young People With Asthma With All Severities
- ClinicalTrials.gov ID
- NCT07643753
- Acronym / sponsor ID
- 1068
- Conditions
- Asthma Childhood, Exercise, Children
- Keywords
- asthma, children, exercise, physical activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 11 Jun 2026 (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.
What is this study about? The investigators want to see if exercise and education sessions can help children and young people (aged 10-17) with asthma, manage the participants asthma better.
The investigators will place participants that are recruited to this study into one of three groups by a computer (randomly):
Group 1:
Usual Care: Continue with normal asthma treatment.
Group 2:
Education: Usual care + a 45-minute online asthma education class once a week.
Group 3:
Exercise \& Education: Usual care + 3 exercise sessions a week and asthma education classes.
Detailed description
This research aims to identify if an exercise and/or asthma education programme, called 'Active Airways', is feasible and acceptable in the paediatric asthma patient. Feasibility, the primary outcome of this study, will be evaluated by calculating the percentage of people approached who participate in the intervention (recruitment) and the percentage who complete the intervention (retention and adherence). The investigators also want to see if the Active Airways programme could improve cardiorespiratory fitness, quality of life and lung function, reduce asthma attacks and reduce healthcare use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- There are three groups for the active airways study: Group 1- usual care Group 2- education only Group 3- exercise and education programme
| Arm | Type | Receives |
|---|---|---|
| Group 1- usual care | No intervention | –Participants will continue to receive usual care from their asthma team/ provider |
| Group 2- education | Active comparator | Other: educationParticipants will receive a 12 week education class on exercise |
| Group 3- exercise | Active comparator | Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION, Other: educationParticipants will take part in a 12 week interval exercise class |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Willing and able to consent to participate in the trial
- Able to understand written and spoken English
- A diagnosis of Mild to Moderate Asthma or Severe Asthma based on the European Respiratory Society (ERS)/ American Thoracic Society (ATS) consensus statement on Severe Asthma
- Able to participate in a formal exercise programme
- Aged 10-17 years
Key exclusion criteria (4 listed)
- Self-reported uncontrolled severe exercise-induced breathlessness
- Required a course of antibiotics or oral corticosteroids within the 4 weeks prior to the study commencing
- Children with severe co-morbidities that will not allow them to participate in an exercise programme e.g. Severe neuromuscular disorders, recent fractures or surgeries, cognitive or behavioural conditions.
- Participant is 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATIONAlso: exercise12 week interval exercise training programme and 12 week education on exercise with asthma | Other | Group 3- exercise |
| educationeducation on exercise and asthma | Other | Group 2- education, Group 3- exercise |
Primary outcome
Recruitment
Time frame: 12 weeks
The percentage of children approached who participate in the intervention (recruitment)
Retention
Time frame: 12 weeks
The percentage of participants that complete the intervention with a retention rate of >70%
10 secondary outcomes
Adherence to programme
Time frame: 12 weeks
Wrist worn accelerometers
Time frame: 12 weeks
Focus groups on patients experience to barriers to an exercise programme
Time frame: 12 weeks
Health beliefs
Time frame: 12 weeks
Respiratory (throat) samples
Time frame: Baseline, 12 weeks, 6 months and 1 year.
Quality of life of participants using the paeditric quality of life inventory (asthma module)
Time frame: Baseline, 12 weeks, 6 months and 1 year
Effectiveness of the programme
Time frame: Baseline, 12 weeks, 6 months and 1 year.
Respiratory (nasal) samples
Time frame: Baseline, 12 weeks, 6 months and 1 year.
Gut samples
Time frame: Baseline, 12 weeks, 6 months and 1 year.
Focus groups on motivators for an exercise programme
Time frame: 12 weeks
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 11 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Erol Gaillard principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION and education in people with Asthma Childhood and Exercise, run by University of Leicester 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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 11 Jun 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?
Contact Naomi Dayman (07487506547, nad21@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 12 weeks). 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 11 Jun 2026.