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START CARE: a protocol for a randomised controlled trial of step-wise budesonide-formoterol reliever-based treatment
Tasmin Barry1,2, Mark Holliday1, Jenny Sparks1
1Medical Research Institute of New Zealand, Wellington, New Zealand.
Insights
This study investigates budesonide-formoterol reliever therapy for childhood asthma. It compares this new approach to standard treatments, aiming to establish its effectiveness and safety in young patients.
Area of Science:
- Pediatric Respiratory Medicine
- Clinical Trials
- Pharmacology
Background:
- Asthma is a leading chronic respiratory illness in children worldwide.
- Inhaled corticosteroid (ICS)-formoterol reliever regimens show promise in adults but require validation in children.
- Limited evidence exists for anti-inflammatory reliever therapy in pediatric asthma management.
Purpose of the Study:
- To evaluate the efficacy and safety of budesonide-formoterol reliever therapy versus standard treatments in children aged 5-11 with asthma.
- To compare budesonide-formoterol reliever alone or as maintenance and reliever therapy (MART) against conventional ICS or ICS-long-acting beta-agonist (LABA) maintenance with short-acting beta-agonist (SABA) reliever.
- To establish an evidence base for novel asthma management strategies in children.
Main Methods:
- A 52-week, multicenter, open-label, randomized controlled trial (RCT) involving 400 children (5-11 years) with varying asthma severity.
- Participants randomized to budesonide-formoterol reliever alone or MART, or to budesonide/budesonide-formoterol maintenance with terbutaline reliever.
- Primary outcome: rate of moderate to severe asthma exacerbations; secondary outcomes include asthma control, lung function, and exhaled nitric oxide.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- This study represents the first RCT comparing budesonide-formoterol reliever strategies with conventional ICS-based therapies in children.
- Results are anticipated to provide crucial evidence for optimizing asthma treatment in pediatric populations.
- The findings will inform clinical guidelines for managing childhood asthma.
Background:
Asthma is the most common chronic childhood respiratory condition globally. Inhaled corticosteroid (ICS)-formoterol reliever-based regimens reduce the risk of asthma exacerbations compared with conventional short-acting β2-agonist (SABA) reliever-based regimens in adults and adolescents. The current limited evidence for anti-inflammatory reliever therapy in children means it is unknown whether these findings are also applicable to children. High-quality randomised controlled trials (RCTs) are needed.
Objective:
The study aim is to determine the efficacy and safety of budesonide-formoterol reliever alone or maintenance and reliever therapy (MART) compared with standard therapy: budesonide or budesonide-formoterol maintenance, both with terbutaline reliever, in children aged 5 to 11 years with mild, moderate and severe asthma.
Methods:
A 52-week, multicentre, open-label, parallel group, phase III, two-sided superiority RCT will recruit 400 children aged 5 to 11 years with asthma. Participants will be randomised 1:1 to either budesonide-formoterol 100/6 µg Turbuhaler reliever alone or MART; or budesonide or budesonide-formoterol Turbuhaler maintenance, with terbutaline Turbuhaler reliever. The primary outcome is moderate and severe asthma exacerbations as rate per participant per year. Secondary outcomes are asthma control, lung function, exhaled nitric oxide and treatment step change. Assessment of Turbuhaler technique and cost-effectiveness analysis are also planned.
Conclusion:
This will be the first RCT to compare the efficacy and safety of a step-wise budesonide-formoterol reliever alone or MART regimen with conventional inhaled ICS or ICS-long-acting β-agonist maintenance plus SABA reliever in children. The results will provide a much-needed evidence base for the treatment of asthma in children.
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