TY - JOUR T1 - 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 JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00271-2021 VL - 7 IS - 4 SP - 00271-2021 AU - Lee Hatter AU - Pepa Bruce AU - Mark Holliday AU - Augustus J. Anderson AU - Irene Braithwaite AU - Andrew Corin AU - Allie Eathorne AU - Arthur Grimes AU - Matire Harwood AU - Thomas Hills AU - Ciléin Kearns AU - Kyley Kerse AU - John Martindale AU - Barney Montgomery AU - Lynn Riggs AU - Davitt Sheahan AU - Nick Shortt AU - Katja Zazulia AU - Mark Weatherall AU - David McNamara AU - Catherine A. Byrnes AU - Andrew Bush AU - Stuart R. Dalziel AU - Richard Beasley Y1 - 2021/10/01 UR - http://openres.ersjournals.com/content/7/4/00271-2021.abstract N2 - 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.This protocol describes the first randomised controlled trial to investigate the efficacy and safety of budesonide/formoterol as sole reliever therapy for children with mild asthma, providing urgently needed evidence in this population https://bit.ly/35v0R3Z ER -