Children’s anti-inflammatory reliever study, United Kingdom (CARE-UK)

A novel reliever strategy for children with asthma: children’s anti-inflammatory reliever study, United Kingdom (CARE-UK)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN65432808

Enrollment

1352

Registered

2024-11-19

Start date

2024-12-01

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paediatric asthma Respiratory

Interventions

Randomisation If the child is eligible for the study they will be randomised. A computer-generated randomisation list will be created and allocation concealed using an online system (OpenClinica). Str

Eligibility

Sex/Gender

All

Age

6 Years to 12 Years

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 10/02/2026: 1. Clinician diagnosis of asthma 2. Children aged =6 to <12 years 3. Washout period of 6 months post previous IMP studies 4. Prescribed asthma medication, (within license) in past 6 months (SABA (salbutamol) with or without ICS or ICS+LABA) 5. Parent or carer able to understand the study requirements and willing to provide informed consent Previous inclusion criteria: 1. Clinician diagnosis of asthma 2. Children aged =6 to <12 years 3. Washout period of 6 months post previous IMP studies 4. Prescribed asthma medication in the past 6 months (SABA, ICS or ICS+LABA) 5. Parent or caregiver able to understand the study requirements and willing to provide informed consent

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 10/02/2026: 1. Other chronic airways disease including but not limited to bronchiectasis, cystic fibrosis, sickle cell disease 2. Children prescribed non-salbutamol SABA (e.g. terbutaline) as their reliever 3. Already using ICS-formoterol as a reliever 4. Children on step 5, very high dose treatment (e.g. high dose ICS/LABA, prescription of biological therapy such as omalizumab) 5. Any known or suspected contraindications to the medications prescribed in the study or their respective excipients: 5.1. Apaflurane (HFA 227) 5.2. Povidone 5.3. Macrogol Previous exclusion criteria: 1. Other chronic airway diseases including but not limited to bronchiectasis, cystic fibrosis, sickle cell disease 2. Already using ICS-formoterol as a reliever 3. Children on step 5, very high dose treatment (e.g. high dose ICS/LABA, prescription of biological therapy such as omalizumab) Added 19/06/2025: 4. Any known or suspected contraindications to the medications

Design outcomes

Primary

Measure	Time frame
Rate of severe asthma attacks: The rate of severe asthma attacks per patient per year, defined as worsening symptoms leading to an urgent medical review resulting in the prescription of systemic corticosteroids, measured at 52 weeks	—

Secondary

Measure	Time frame
1. Rate of total asthma attacks: The rate of total asthma attacks per patient per year, defined as worsening symptoms leading to an urgent medical review, whether or not systemic corticosteroids are prescribed, measured at 52 weeks 2. Time to first severe attack: Time to first severe asthma attack measured in weeks from baseline over the 52-week study period 3. Proportion of participants with severe attacks: Proportion of participants experiencing at least one severe asthma attack, measured at 52 weeks 4. Days lost from school: Number of days lost from school due to asthma, measured annually 5. Days lost from work for childcare: Number of days lost from work due to caring for a child with asthma, measured annually 6. Change in Childhood Asthma Control Test (cACT): Change in cACT scores measured from baseline to 52 weeks 7. Change in Paediatric Asthma Quality of Life Questionnaire (PAQLQ): Change in PAQLQ scores measured from baseline to 52 weeks 8. Growth during the study period: Change in height from baseline to study completion at 52 weeks 9. Total ICS dose: Total inhaled corticosteroid (ICS) dose as measured by an electronic monitoring device or prescription records at 52 weeks 10. Total systemic corticosteroid dose: Total dose of systemic corticosteroids prescribed over 52 weeks 11. Change in Child Health Utility (CHU9D): Change in CHU9D scores measured from baseline over the course of the 52-week study 12. Quality Adjusted Life Years (QALYs): QALYs calculated as the area under the CHU9D curve over 52 weeks 13. Cost of asthma-related healthcare: Total cost of asthma-related healthcare utilization measured over 52 weeks	—

Measure

Time frame

1. Rate of total asthma attacks: The rate of total asthma attacks per patient per year, defined as worsening symptoms leading to an urgent medical review, whether or not systemic corticosteroids are prescribed, measured at 52 weeks 2. Time to first severe attack: Time to first severe asthma attack measured in weeks from baseline over the 52-week study period 3. Proportion of participants with severe attacks: Proportion of participants experiencing at least one severe asthma attack, measured at 52 weeks 4. Days lost from school: Number of days lost from school due to asthma, measured annually 5. Days lost from work for childcare: Number of days lost from work due to caring for a child with asthma, measured annually 6. Change in Childhood Asthma Control Test (cACT): Change in cACT scores measured from baseline to 52 weeks 7. Change in Paediatric Asthma Quality of Life Questionnaire (PAQLQ): Change in PAQLQ scores measured from baseline to 52 weeks 8. Growth during the study period: Change in height from baseline to study completion at 52 weeks 9. Total ICS dose: Total inhaled corticosteroid (ICS) dose as measured by an electronic monitoring device or prescription records at 52 weeks 10. Total systemic corticosteroid dose: Total dose of systemic corticosteroids prescribed over 52 weeks 11. Change in Child Health Utility (CHU9D): Change in CHU9D scores measured from baseline over the course of the 52-week study 12. Quality Adjusted Life Years (QALYs): QALYs calculated as the area under the CHU9D curve over 52 weeks 13. Cost of asthma-related healthcare: Total cost of asthma-related healthcare utilization measured over 52 weeks

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Countries

England, Scotland, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026