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Randomized Controlled Trial
. 2018 Jan-Dec:12:1753466618777924.
doi: 10.1177/1753466618777924.

Efficacy and safety of fluticasone propionate/formoterol fumarate in pediatric asthma patients: a randomized controlled trial

Anna Płoszczuk  1 , Miroslava Bosheva  2 , Kay Spooner  3 , Tammy McIver  3 , Sanjeeva Dissanayake  3
Affiliations
Randomized Controlled Trial

Efficacy and safety of fluticasone propionate/formoterol fumarate in pediatric asthma patients: a randomized controlled trial

Anna Płoszczuk et al. Ther Adv Respir Dis. 2018 Jan-Dec.

Abstract

Background: The efficacy and safety of fluticasone propionate/formoterol fumarate pressurized metered-dose inhaler (pMDI) (fluticasone/formoterol; Flutiform®; 100/10 µg b.i.d.) was compared with fluticasone propionate (Flixotide® Evohaler® pMDI; 100 µg b.i.d.) and fluticasone/salmeterol (Seretide® Evohaler® pMDI; 100/50 µg b.i.d.) in a pediatric asthma population (EudraCT number: 2010-024635-16).

Methods: A double-blind, double-dummy, parallel group, multicenter study. Patients, aged 5-<12 years with persistent asthma ⩾ 6 months and forced expiratory volume in 1 s (FEV1) ⩽ 90% predicted were randomized 1:1:1 to 12 weeks' treatment. The study objectives were to demonstrate superiority of fluticasone/formoterol to fluticasone and non-inferiority to fluticasone/salmeterol.

Results: A total of 512 patients were randomized: fluticasone/formoterol, 169; fluticasone, 173; fluticasone/salmeterol, 170. Fluticasone/formoterol was superior to fluticasone for the primary endpoint: change from predose FEV1 at baseline to 2 h postdose FEV1 over 12 weeks [least squares (LS) mean difference 0.07 l; 95% confidence interval (CI) 0.03, 0.11; p < 0.001] and the first key secondary endpoint, FEV1 area under the curve over 4 hours (AUC0-4 h) at week 12 (LS mean difference 0.09 l; 95% CI: 0.04, 0.13; p < 0.001). Per a prespecified non-inferiority margin of -0.1 l, fluticasone/formoterol was non-inferior to fluticasone/salmeterol for the primary endpoint (LS mean difference 0.00 l; 95% CI -0.04, 0.04; p < 0.001) and first key secondary endpoint (LS mean difference 0.01; 95% CI -0.03, 0.06; p < 0.001). Fluticasone/formoterol was non-inferior to fluticasone/salmeterol for the second key secondary endpoint, change from predose FEV1 over 12 weeks (treatment difference -0.02 l; 95% CI -0.06, 0.02; p < 0.001), but was not superior to fluticasone for this endpoint (LS mean difference 0.03 l; 95% CI -0.01, 0.07; p = 0.091). All treatments elicited large improvements from baseline to week 12 for the Pediatric Asthma Quality of Life Questionnaire (LS mean change 0.76 to 0.85 units) and Asthma Control Questionnaire (LS mean change -1.03 to -1.13 units). Few severe exacerbations were seen (fluticasone/formoterol: two; fluticasone/salmeterol: two). All treatments were well tolerated.

Conclusions: This study supports the efficacy and safety of fluticasone/formoterol in a pediatric asthma population and its superiority to fluticasone.

Keywords: ICS/LABA; asthma; children; combination therapy; fluticasone propionate; formoterol fumarate.

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Conflict of interest statement

Conflict of interest statement: Kay Spooner is an employee of the study sponsor, Mundipharma Research Limited. Tammy McIver and Sanjeeva Dissanayake were employees of the study sponsor at the time this study was conducted.

Anna Ploszczuk and Miroslava Bosheva have no conflicts of interest to disclose.

Figures

Figure 1.
Figure 1.
Study design. b.i.d., twice daily; R, randomization; V, visit.
Figure 2.
Figure 2.
Patient flow diagram.
Figure 3.
Figure 3.
Least squares mean change from predose forced expiratory volume in 1 s at baseline to 2 h postdose over the 12-week treatment period, full analysis population.
Figure 4.
Figure 4.
Forced expiratory volume in 1 s area under the curve over 4 h at week 12, full analysis population.
Figure 5.
Figure 5.
Change in predose forced expiratory volume in 1 s (litres) from baseline over the 12-week treatment period, full analysis population.
Figure 6.
Figure 6.
Change from clinic predose peak flow (PEFR) at baseline to predose PEFR over the 12-week treatment period, full analysis population.
Figure 7.
Figure 7.
Change from clinic predose peak flow (PEFR) at baseline to 2 h postdose PEFR over 12-week treatment period, full analysis population.
See this image and copyright information in PMC

References

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