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The Children's Anti-inflammatory Reliever (CARE) study: a protocol for a randomised controlled trial of
Lee Hatter1,2, Pepa Bruce1, Mark Holliday1
1Medical Research Institute of New Zealand, Wellington, New Zealand.
Insights
This study compares budesonide-formoterol to salbutamol for mild childhood asthma. It aims to provide evidence on the safety and effectiveness of budesonide-formoterol as a reliever therapy in children.
Area of Science:
- Pediatric Pulmonology
- Clinical Trials
- Pharmacotherapy
Background:
- Asthma is a leading chronic childhood illness, often treated solely with short-acting β2-agonists (SABAs).
- Evidence supports budesonide-formoterol over SABA monotherapy in adults for reducing severe asthma exacerbations.
- Data is lacking on budesonide-formoterol's efficacy and safety in pediatric mild asthma populations.
Purpose of the Study:
- To evaluate the efficacy and safety of as-needed budesonide-formoterol versus as-needed salbutamol in children aged 5-15 with mild asthma.
- To establish an evidence base for reliever therapy in pediatric mild asthma.
Main Methods:
- Phase III, open-label, randomized controlled trial (RCT) over 52 weeks.
- Recruitment of 380 children (5-15 years) with mild asthma.
- Comparison of budesonide-formoterol (50/3 µg, 2 actuations PRN) vs. salbutamol (100 µg, 2 actuations PRN).
Main Results:
- Primary outcome: asthma attack rate per participant per year.
- Secondary outcomes: asthma control, lung function, exhaled nitric oxide, and treatment escalation.
- Cost-effectiveness analysis planned.
Conclusions:
- This is the first RCT investigating as-needed budesonide-formoterol for mild pediatric asthma.
- Results will inform treatment guidelines for mild asthma in children.
- Provides crucial evidence for pediatric asthma management strategies.
Background:
Asthma is the most common chronic disease in children, many of whom are managed solely with a short-acting β2-agonist (SABA). In adults, the evidence that budesonide-formoterol as sole reliever therapy markedly reduces the risk of severe exacerbations compared with SABA alone has contributed to the Global Initiative for Asthma recommending against SABA monotherapy in this population. The current lack of evidence in children means it is unknown whether these findings are also relevant to this demographic. High-quality randomised controlled trials (RCTs) are needed.
Objective:
The aim of this study is to determine the efficacy and safety of as-needed budesonide-formoterol therapy compared with as-needed salbutamol in children aged 5 to 15 years with mild asthma, who only use a SABA.
Methods:
A 52-week, open-label, parallel group, phase III RCT will recruit 380 children aged 5 to 15 years with mild asthma. Participants will be randomised 1:1 to either budesonide-formoterol (Symbicort Rapihaler®) 50/3 µg, two actuations as needed, or salbutamol (Ventolin®) 100 µg, two actuations as needed. The primary outcome is asthma attacks as rate per participant per year. Secondary outcomes assess asthma control, lung function, exhaled nitric oxide and treatment step change. A cost-effectiveness analysis is also planned.
Conclusion:
This is the first RCT to assess the safety and efficacy of as-needed budesonide-formoterol in children with mild asthma. The results will provide a much-needed evidence base for the treatment of mild asthma in children.
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