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

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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.

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Acknowledgements

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.

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  1. Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    Emma D. Deeks & Zaina T. Al-Salama

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  1. Emma D. Deeks
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  2. Zaina T. Al-Salama
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Correspondence to Emma D. Deeks.

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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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Deeks, E.D., Al-Salama, Z.T. Fluticasone propionate/formoterol fumarate in children aged ≥ 5 years with asthma: a profile of its use. Drugs Ther Perspect 35, 601–606 (2019). https://doi.org/10.1007/s40267-019-00685-x

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  • DOI: https://doi.org/10.1007/s40267-019-00685-x

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