A Proposed Revision of the Stepwise Treatment Algorithm in Asthma

Beasley, Richard; Bruce, Pepa; Hatter, Lee; Braithwaite, Irene; Semprini, Alex; Kearns, Ciléin; Weatherall, Mark; Pavord, Ian D.

doi:10.1164/rccm.202101-0224le

Cited by 2 publications

(3 citation statements)

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“…Participants receiving budesonide-formoterol will be escalated using a paediatric-dose-adjusted anti-inflammatory reliever regimen, transitioning from budesonide-formoterol as needed to maintenance and reliever therapy (MART), very-low-dose at step 2 and, if a further severe asthma attack occurs, low-dose at step 3. This is in line with the proposed children's [27] and adult [20,21] anti-inflammatory reliever therapy algorithms.…”

Section: Interventionssupporting

confidence: 85%

“…Participants in both arms are recommended to seek medical help the same day if they use 12 or more actuations in 24 hours, and to call for an ambulance if they have used 16 or more. The maximum recommended daily dose of budesonide-formoterol (800/48mcg) was determined based on the relative dose equivalence of formoterol 6mcg with salbutamol 200mcg [39,40,41], available regulatory safety datasheets, and the results of MART in children [21].…”

Section: Discussionmentioning

confidence: 99%

“…Firstly, the Global Initiative for Asthma (GINA) stopped recommending SABA monotherapy for adults and adolescents with asthma [ 18 ]. Secondly, the extension of evidence for ICS-formoterol from Maintenance And Reliever Therapy (MART) in moderate and severe asthma [ 19 ] to include as-needed therapy in mild asthma gave rise to the Anti-Inflammatory Reliever (AIR) concept, in which ICS-formoterol is used as a reliever, with or without maintenance ICS-formoterol, across the spectrum of asthma severity [ 20 , 21 ]. This approach makes it possible for most patients to be managed with a single ICS-formoterol combination inhaler, with the maintenance dose determined by baseline asthma severity, and the frequency of reliever use titrated in response to symptoms.…”

Section: Introductionmentioning

confidence: 99%

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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

et al. 2021

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BackgroundAsthma 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 lack of current evidence in children means it is unknown whether these findings are also relevant to this demographic. High-quality randomised controlled trials (RCTs) are needed.ObjectiveTo determine the efficacy and safety of as-needed budesonide-formoterol therapy compared with as-needed salbutamol in children aged five to 15 years with mild asthma, who only use a SABA.MethodsA 52-week, open-label, parallel group, phase III, RCT will recruit 380 children aged five to 15 years with mild asthma (ACTRN12620001091998). Participants will be randomised 1:1 to either budesonide-formoterol (Symbicort Rapihaler®) 50/3mcg, two actuations as needed or salbutamol (Ventolin®) 100mcg, 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.ConclusionThis 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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Section: Interventionssupporting

confidence: 85%