A novel reliever strategy for children with asthma: children’s anti-inflammatory reliever study, United Kingdom (CARE-UK)
Paediatric asthma
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). Stratified block randomisation will be used. The randomisation will be stratified by: a. Site b. Current GINA treatment step (see ‘Dosing Regimen’ below for more details) The study is open-label. Blinding is not being performed in order to maintain the potential real-world advantage of ICS-formoterol as a reliever. Control (Standard Care) Arm Patients in the control arm will continue with their current standard treatment as prescribed by their usual healthcare provider. This will be one of either: • SABA: A short-acting bronchodilator that provides immediate relief for asthma symptoms. • ICS: An inhaled corticosteroid that can be used as maintenance therapy. • ICS-LABA: A combination of an inhaled corticosteroid and a long-acting bronchodilator that can be used as a controller therapy or for reliever therapy. Intervention Arm Patients in the intervention arm will be issued two budesonide-formoterol (Symbicort®) 100/3 MDIs and a compatible spacer device such as Aerochamber Plus. One for home, maintenance and reliever doses, and the other to be kept at school for reliever use. Dose Regimen In clinical practice, treatment is stepped up and down depending on clinical control in terms of symptoms and risk of an asthma attack. Stepping up and down will be determined by the patient’s usual healthcare provider. For those in the intervention arm participants will increase or decrease the number of maintenance budesonide-formoterol puffs per day. The control arm will continue as per usual clinical care whereby the ICS dose is increased or decreased and additional controllers such as LABAs are added or removed depending on clinical control. The starting dose for budesonide-formoterol will be based on the dose of usual care inhaled corticosteroid ((ICS) low, medium or high) p
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
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