Fluticasone propionate/formoterol fumarate in children aged ≥ 5 years with asthma: a profile of its use

Abstract

The fluticasone propionate/formoterol fumarate (hereafter fluticasone/formoterol) 50/5 µg pressurized metered-dose inhaler (pMDI) [Flutiform®] is a fixed-dose combination of an inhaled corticosteroid (ICS) and a long-acting β2-adrenoceptor agonist (LABA) for the regular treatment of asthma where regular use of an ICS and a LABA combination product is appropriate. In the EU, the fluticasone/formoterol 50/5 µg pMDI is recommended for use in adults, adolescents and children aged ≥ 5 years, with the latter being a recent expansion of the indicated population and the focus of this review. Fluticasone/formoterol 50/5 µg, administered as two actuations (i.e. 100/10 µg) twice daily, provided benefit over fluticasone propionate 100 µg twice daily and was noninferior to fluticasone/salmeterol 100/50 µg twice daily, in improving lung function in patients aged 5 to < 12 or 4–12 years in randomized trials. Fluticasone/formoterol was generally similar to each of these comparator pMDI regimens in terms of asthma exacerbation rates and patient-reported measures and was generally well tolerated, with no evidence of clinically meaningful systemic adverse effects over up to 36 weeks of treatment. Longer-term data would be of interest.