Trial reportPediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology2019
The efficacy and safety of fluticasone/salmeterol compared to fluticasone in children younger than four years of age.
Trial report in Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.
- 2020 Brazilian Thoracic Association recommendations for the management of asthma.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e TisilogiaGuideline
- The efficacy and safety of fluticasone/salmeterol compared to fluticasone in children younger than four years of age.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2019Trial
- Efficacy and safety of tiotropium in partial and uncontrolled preschool asthma (TIPP): a phase III, multicentre, randomised, double-blind, placebo-controlled trial.EClinicalMedicine · 2026Article
- Early initiation of inhaled corticosteroid-long-acting βPediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2026Article
- Clinical Outcomes Associated With Long-Acting Beta Agonist Escalation in Preschool Children With Severe Asthma: A Retrospective Hospital Based Clinic Cohort Study.Pediatric pulmonology · 2026Observational
- Pharmacoeconomic evaluation of ICS-LABA therapy in pediatric asthma: a cost-effectiveness and cost-utility analysis.Frontiers in pharmacology · 2025Article
- Characteristics of children with severe preschool asthma prior to starting the TIPP study.Frontiers in pediatrics · 2025Article
- Diagnosis and management of asthma in infants and preschoolers.Clinical and experimental pediatrics · 2022Article
- Management of Preschool Wheezing: Guideline from the Emilia-Romagna Asthma (ERA) Study Group.Journal of clinical medicine · 2022Article
- New Perspectives in the Management of Mild to Moderate Asthma in Children.Journal of asthma and allergy · 2021Review
- Tiotropium as an Add-on Treatment Option for Severe Uncontrolled Asthma in Preschool Patients.Journal of asthma and allergy · 2021Article
- Hospitalization, Asthma Phenotypes, and Readmission Rates in Pre-school Asthma.Frontiers in pediatrics · 2020Article
- Article
Corrections and comments
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Authors and funding
9 authors at 6 institutions in 3 countries.
Funding
Abstract
backgroundFluticasone propionate 50 μg/salmeterol xinafoate 25 μg (FP/SAL) is widely used in adults and children with asthma, but there is sparse information on its use in very young children.
methodsThis was a randomized, double-blind, multicentre, controlled trial conducted in children aged 8 months to 4 years. During a 2-week run-in period, they all received FP twice daily. At randomization, they commenced FP/SAL or FP twice daily for 8 weeks. All were then given FP/SAL only, in a 16-week open-label study continuation. Medications were inhaled through an AeroChamber Plus with attached face mask. The primary end-point was mean change in total asthma symptom scores from baseline to the last 7 days of the double-blind period. Analyses were undertaken in all children randomized to treatment and who received at least one dose of study medication.
resultsThree hundred children were randomized 1:1 to receive FP/SAL or FP. Mean change from baseline in total asthma symptom scores was -3.97 for FP/SAL and -3.01 with FP. The between-group difference was not statistically significant (P = 0.21; 95% confidence interval: -2.47, 0.54). No new safety signals were seen with FP/SAL.
conclusionThis is the first randomized, double-blind study of this size to evaluate FP/SAL in very young children with asthma. FP/SAL did not show superior efficacy to FP; no clear add-on effect of SAL was demonstrated. No clinically significant differences in safety were noted with FP/SAL usage.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.