Fluticasone propionate/formoterol fumarate in children aged ≥ 5 years with asthma: a profile of its use
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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.
The manuscript was reviewed by: T. Leung, Department of Paediatrics and Adolescent Medicine, Faculty of Medicine, University of Hong Kong, Hong Kong SAR; Z. Teitelbaum, Clinical Toxicology and Pharmacology Department, Rambam Medical Center, Haifa, Israel. During the peer review process, Mundipharma, the marketing-authorization holder of the Flutiform® pMDI, was also offered an opportunity to provide a scientific accuracy review of their data. Changes resulting from comments received were made on the basis of scientific and editorial merit.
Compliance with ethical standards
The preparation of this review was not supported by any external funding.
Conflict of interest
E. D. Deeks and Z. T. Al-Salama are employees of Adis International Ltd/Springer Nature, are responsible for the article content and declare no conflicts of interest.
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