The Children's Anti-inflammatory Reliever (CARE) study: a protocol for a randomised controlled trial of budesonide-formoterol as sole reliever therapy in children with mild asthma.
Journal
ERJ open research
ISSN: 2312-0541
Titre abrégé: ERJ Open Res
Pays: England
ID NLM: 101671641
Informations de publication
Date de publication:
Oct 2021
Oct 2021
Historique:
received:
19
04
2021
accepted:
08
06
2021
entrez:
2
12
2021
pubmed:
3
12
2021
medline:
3
12
2021
Statut:
epublish
Résumé
Asthma is the most common chronic disease in children, many of whom are managed solely with a short-acting β 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. 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 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.
Sections du résumé
BACKGROUND
BACKGROUND
Asthma is the most common chronic disease in children, many of whom are managed solely with a short-acting β
OBJECTIVE
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
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
CONCLUSION
CONCLUSIONS
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.
Identifiants
pubmed: 34853785
doi: 10.1183/23120541.00271-2021
pii: 00271-2021
pmc: PMC8628747
pii:
doi:
Types de publication
Journal Article
Langues
eng
Informations de copyright
Copyright ©The authors 2021.
Déclaration de conflit d'intérêts
Conflict of interest: L. Hatter has nothing to disclose. Conflict of interest: P. Bruce has nothing to disclose. Conflict of interest: M. Holliday has nothing to disclose. Conflict of interest: A.J. Anderson has nothing to disclose. Conflict of interest: I. Braithwaite has nothing to disclose. Conflict of interest: A. Corin has nothing to disclose. Conflict of interest: A. Eathorne has nothing to disclose. Conflict of interest: A. Grimes has nothing to disclose. Conflict of interest: M. Harwood has nothing to disclose. Conflict of interest: T. Hills reports financial support for the present manuscript from the Health Research Council for New Zealand, by way of a research grant. Conflict of interest: C. Kearns has nothing to disclose. Conflict of interest: K. Kerse has nothing to disclose. Conflict of interest: J. Martindale has nothing to disclose. Conflict of interest: B. Montgomery has nothing to disclose. Conflict of interest: L. Riggs has nothing to disclose. Conflict of interest: D. Sheahan has nothing to disclose. Conflict of interest: N. Shortt reports financial and nonfinancial support for the present manuscript from HRC (NZ), Cure Kids and AstraZeneca. Conflict of interest: K. Zazulia has nothing to disclose. Conflict of interest: M. Weatherall has nothing to disclose. Conflict of interest: D. McNamara has nothing to disclose. Conflict of interest: C.A. Byrnes reports grants from the Health Research Council, FluLab, Curekids, and the National Health and Medical Research Council, outside the submitted work; and is an active Editorial Board member for the NZ Formulary for Children. Conflict of interest: A. Bush has nothing to disclose. Conflict of interest: S.R. Dalziel reports financial and nonfinancial support for the present manuscript from HRC (NZ), Cure Kids and AstraZeneca. Conflict of interest: R. Beasley reports financial and nonfinancial support for the present manuscript from HRC (NZ), Cure Kids and AstraZeneca; research funding from AstraZeneca and Genentech, and payment or honoraria received from AstraZeneca, Cipla, Avillion and Theravance, outside the submitted work; and a leadership or fiduciary role in the Asthma and Respiratory Foundation (NZ), outside the submitted work.
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