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

Publisher: Blackwell Publishing Country of Publication: England NLM ID: 9106718 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1399-3038 (Electronic) Linking ISSN: 09056157 NLM ISO Abbreviation: Pediatr Allergy Immunol Subsets: MEDLINE

Publication: <2010->: Oxford, UK : Blackwell Publishing
Original Publication: Copenhagen : Munksgaard, c1990-

Asthma/*drug therapy ; Bronchodilator Agents/*therapeutic use ; Fluticasone-Salmeterol Drug Combination/*therapeutic use; Administration, Inhalation ; Bronchodilator Agents/adverse effects ; Child, Preschool ; Double-Blind Method ; Fluticasone-Salmeterol Drug Combination/adverse effects ; Follow-Up Studies ; Humans ; Infant ; Japan ; Severity of Illness Index ; Treatment Outcome

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

Clin Exp Allergy. 2003 May;33(5):573-8. (PMID: 12752584)
Arch Dis Child. 1978 Jul;53(7):532-5. (PMID: 686789)
Allergy. 2012 Aug;67(8):976-97. (PMID: 22702533)
Am J Respir Crit Care Med. 2007 Nov 1;176(9):858-64. (PMID: 17702968)
Thorax. 2006 Aug;61(8):722-8. (PMID: 16877691)
Ann Allergy Asthma Immunol. 1999 Sep;83(3):231-9. (PMID: 10507269)
N Engl J Med. 2016 Sep 1;375(9):840-9. (PMID: 27579634)
Eur Respir J. 2006 Jan;27(1):29-35. (PMID: 16387932)
Respir Med. 2005 Nov;99(11):1393-402. (PMID: 15916891)
Allergy Asthma Proc. 2013 May-Jun;34(3):210-9. (PMID: 23462278)
Cochrane Database Syst Rev. 2008 Jul 16;(3):CD006363. (PMID: 18646149)
Ther Adv Drug Saf. 2013 Dec;4(6):254-63. (PMID: 25114786)
Allergol Int. 2015 Oct;64(4):371-6. (PMID: 26433534)
Eur Respir J. 1999 Jan;13(1):78-81. (PMID: 10836327)
Pediatr Allergy Immunol. 2019 Mar;30(2):195-203. (PMID: 30556939)
Drug Res (Stuttg). 2016 Jul;66(7):371-6. (PMID: 27273710)
N Engl J Med. 1995 Jan 19;332(3):133-8. (PMID: 7800004)
N Engl J Med. 2016 May 12;374(19):1822-30. (PMID: 26949137)
J Asthma. 2019 Jun;56(6):573-580. (PMID: 29958011)
Pediatrics. 1999 Feb;103(2):414-21. (PMID: 9925834)

International GlaxoSmithKline

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

ClinicalTrials.gov NCT02113436

0 (Bronchodilator Agents)
0 (Fluticasone-Salmeterol Drug Combination)

Date Created: 20181218 Date Completed: 20190412 Latest Revision: 20210109

20250114

PMC6850202

10.1111/pai.13010

30556939