START CARE: a protocol for a randomised controlled trial of step-wise budesonide–formoterol reliever-based treatment in children. Barry, T., Holliday, M., Sparks, J., Biggs, R., Colman, A., Lamb, R., Oldfield, K., Shortt, N., Kerse, K., Martindale, J., Eathorne, A., Walton, M., Black, B., Harwood, M., Bruce, P., Semprini, R., Bush, A., Fleming, L., Byrnes, C. A., McNamara, D., Hatter, L., Dalziel, S. R., Weatherall, M., & Beasley, R. ERJ Open Research, 10(2):00897–2023, March, 2024.
START CARE: a protocol for a randomised controlled trial of step-wise budesonide–formoterol reliever-based treatment in children [link]Paper  doi  abstract   bibtex   
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 β 2 -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.
@article{barry_start_2024,
	title = {{START} {CARE}: a protocol for a randomised controlled trial of step-wise budesonide–formoterol reliever-based treatment in children},
	volume = {10},
	issn = {2312-0541},
	shorttitle = {{START} {CARE}},
	url = {http://openres.ersjournals.com/lookup/doi/10.1183/23120541.00897-2023},
	doi = {10.1183/23120541.00897-2023},
	abstract = {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 β 
                2 
                -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.},
	language = {en},
	number = {2},
	urldate = {2024-08-11},
	journal = {ERJ Open Research},
	author = {Barry, Tasmin and Holliday, Mark and Sparks, Jenny and Biggs, Rowan and Colman, Atalie and Lamb, Rebekah and Oldfield, Karen and Shortt, Nick and Kerse, Kyley and Martindale, John and Eathorne, Allie and Walton, Michaela and Black, Bianca and Harwood, Matire and Bruce, Pepa and Semprini, Ruth and Bush, Andrew and Fleming, Louise and Byrnes, Catherine A. and McNamara, David and Hatter, Lee and Dalziel, Stuart R. and Weatherall, Mark and Beasley, Richard},
	month = mar,
	year = {2024},
	pages = {00897--2023},
}
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