The efficacy and safety of fluticasone/salmeterol compared to fluticasone in children younger than four years of age

Shigemi Yoshihara, Toshikazu Tsubaki, Masanori Ikeda, Warren Lenney, Richard Tomiak, Takako Hattori, Kenichi Hashimoto, Toru Soutome, Shihona Kato, Shigemi Yoshihara, Toshikazu Tsubaki, Masanori Ikeda, Warren Lenney, Richard Tomiak, Takako Hattori, Kenichi Hashimoto, Toru Soutome, Shihona Kato

Abstract

Background: Fluticasone 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.

Methods: This 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.

Results: Three 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.

Conclusion: This 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.

Trial registration: ClinicalTrials.gov NCT02113436.

Keywords: asthma; child; combination therapy; double-blind; fluticasone propionate; randomized; salbutamol; salmeterol.

Conflict of interest statement

Authors SY, TT and MI did not receive any personal payments from GSK, but their institutions received research grants from GSK. WL, RT and TH are GSK employees and shareholders. TS is a GSK KK employee and does not hold GSK shares. KH and SK are GSK KK employees and hold GSK shares. None of the authors has been involved in other activities that may have influenced the study findings.

© 2018 The Authors. Pediatric Allergy and Immunology Published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
The duration of the study was 27 weeks. During the run‐in, all children aged ≥2 years received inhaled FP 50 μg, 1 or 2 puffs twice daily (100 or 200 μg/day) according to the judgment of the investigator; those

Figure 2

Study enrolment flow chart

Figure 2

Study enrolment flow chart

Figure 2
Study enrolment flow chart

Figure 3

Mean change from baseline over…

Figure 3

Mean change from baseline over time in weekly total (daytime plus night‐time) asthma…

Figure 3
Mean change from baseline over time in weekly total (daytime plus night‐time) asthma symptom scores in the double‐blind and open‐label extension periods
Figure 2
Figure 2
Study enrolment flow chart
Figure 3
Figure 3
Mean change from baseline over time in weekly total (daytime plus night‐time) asthma symptom scores in the double‐blind and open‐label extension periods

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