2019
DOI: 10.1111/pai.13010
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The efficacy and safety of fluticasone/salmeterol compared to fluticasone in children younger than four years of age

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 co… Show more

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Cited by 19 publications
(19 citation statements)
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“…The annual exacerbation rate of our patients was rather constant during the past 10 years although there was a significant treatment switch of our hospital policy from ICS to an ICS + LABA combination, which was successfully implemented as set up treatment in uncontrolled asthma of school children (30) (Figure 2). Although the number of patients with adherence to treatment was small, our data are in accordance with two recent reports which showed that the ICS + LABA combination was not superior to ICS alone in pre-school asthma (23,24).…”
Section: Discussionsupporting
confidence: 91%
See 1 more Smart Citation
“…The annual exacerbation rate of our patients was rather constant during the past 10 years although there was a significant treatment switch of our hospital policy from ICS to an ICS + LABA combination, which was successfully implemented as set up treatment in uncontrolled asthma of school children (30) (Figure 2). Although the number of patients with adherence to treatment was small, our data are in accordance with two recent reports which showed that the ICS + LABA combination was not superior to ICS alone in pre-school asthma (23,24).…”
Section: Discussionsupporting
confidence: 91%
“…ICS dose did not reduce the rate of severe asthma exacerbations and may be associated with diminished linear growth (21,22). In addition, in children with persistent asthma, the combination of ICS and additional long acting beta agonists (LABA) was not associated with a significant reduction of exacerbations requiring systemic steroids (23,24).…”
Section: Introductionmentioning
confidence: 99%
“…We emphasize that there have been very few studies evaluating the efficacy and safety of the use of this combination in this age group. (47,70,71) In this situation, referring the patient to a specialist should be considered.…”
Section: Maintenance Therapymentioning
confidence: 99%
“…A short-term (8 week) placebo-controlled study did not show any significant difference in symptoms between combination fluticasone propionate-salmeterol vs fluticasone propionate alone; no additional safety signals were noted in the group receiving LABA. 674…”
Section: Not Recommendedmentioning
confidence: 99%