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

Paulo Marcio Pitrez, Sira Nanthapisal, Ana Paula Beltran Moschione Castro, Chirag Teli, Abhijith P G

Journal: BMJ open respiratory research 2023;10(1):e001706

PMID: 37620110

Abstract

BACKGROUND

Fluticasone propionate/salmeterol xinafoate (FP/SAL) is an inhaled corticosteroid (ICS) and long-acting β-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 β-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.

© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Address: Pediatric Pulmonology Division, Hospital Santa Casa de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil [email protected].; Department of Pediatrics, Faculty of Medicine, Thammasat University, Pathum Thani, Thailand.; Faculdade de Medicina, Hospital das Clínicas, Instituto da Criança e do Adolescente, Universidade de São Paulo, São Paulo, Brazil.; General Medicines, GSK, Mumbai, India.; General Medicines, GSK, Singapore.
Bant logo

© Copyright 2026, Nutrition Evidence

NED wishes to thank the following organisations for their support:

We use cookies to improve your experience and analyze site traffic with Google Analytics. By continuing to use our site, you agree to our use of cookies. Learn more.