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. 2023 Aug;10(1):e001706.
doi: 10.1136/bmjresp-2023-001706.

Managing moderate-to-severe paediatric asthma: a scoping review of the efficacy and safety of fluticasone propionate/salmeterol

Paulo Marcio Pitrez  1 , Sira Nanthapisal  2 , Ana Paula Beltran Moschione Castro  3 , Chirag Teli  4 , Abhijith P G  5
Affiliations

Managing moderate-to-severe paediatric asthma: a scoping review of the efficacy and safety of fluticasone propionate/salmeterol

Paulo Marcio Pitrez et al. BMJ Open Respir Res. 2023 Aug.

Abstract

Background: Fluticasone propionate/salmeterol xinafoate (FP/SAL) is an inhaled corticosteroid (ICS) and long-acting β2-agonist (LABA) combination, indicated for the regular treatment of children (aged >4 years) with asthma that is inadequately controlled with ICS monotherapy plus as-needed short-acting β2-agonists, or already adequately controlled with ICS/LABA.

Objective: Compared with the adult population, fewer clinical studies have investigated the efficacy of FP/SAL in paediatric patients with moderate and moderate-to-severe asthma. In this review, we synthesise the available evidence for the efficacy and safety of FP/SAL in the paediatric population, compared with other available therapies indicated for asthma in children.

Eligibility criteria: A literature review identified randomised controlled trials and observational studies of FP/SAL in the paediatric population with moderate-to-severe asthma.

Sources of evidence: The Medline database was searched using PubMed (https://pubmed.ncbi.nlm.nih.gov/), with no publication date restrictions. Search strategies were developed and refined by authors.

Charting methods: Selected articles were screened for clinical outcome data (exacerbation reduction, nocturnal awakenings, lung function, symptom control, rescue medication use and safety) and a table of key parameters developed.

Results: Improvements in asthma outcomes with FP/SAL include reduced risk of asthma-related emergency department visits and hospitalisations, protection against exercise-induced asthma and improvements in measures of lung function. Compared with FP monotherapy, greater improvements in measures of lung function and asthma control are reported. In addition, reduced incidence of exacerbations, hospitalisations and rescue medication use is observed with FP/SAL compared with ICS and leukotriene receptor antagonist therapy. Furthermore, FP/SAL therapy can reduce exposure to both inhaled and oral corticosteroids.

Conclusions: FP/SAL is a reliable treatment option in patients not achieving control with ICS monotherapy or a different ICS/LABA combination. Evidence shows that FP/SAL is well tolerated and has a similar safety profile to FP monotherapy. Thus, FP/SAL provides an effective option for the management of moderate-to-severe asthma in the paediatric population.

Keywords: asthma; asthma in primary care; paediatric asthma; paediatric physician.

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Conflict of interest statement

Competing interests: PMP has acted as a speaker/consultant for AstraZeneca, GSK, Novartis, Boehringer Ingelheim and Sanofi. SN has acted as a speaker/consultant for AstraZeneca, GSK, Novartis, Boehringer Ingelheim and Sanofi. APMC has acted as a speaker/consultant for Danone, Nutricia, AbbVie and Sanofi. CT and APG are full-time employees of GSK and hold shares in GSK.

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