Drugs & Therapy Perspectives

, Volume 35, Issue 12, pp 601–606 | Cite as

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

  • Emma D. DeeksEmail author
  • Zaina T. Al-Salama
Adis Drug Q&A


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.


  1. 1.
    Global Initiative for Asthma. Global strategy for asthma management and prevention (2019 update). 2019. Accessed 24 Oct 2019.
  2. 2.
    World Health Organization. Asthma—key facts. 2017. Accessed 24 Oct 2019.
  3. 3.
    Scottish Intercollegiate Guidelines Network. SIGN158. British guideline on the management of asthma. 2019. Accessed 24 Oct 2019.
  4. 4.
    Flutiform® 50 microgram/5 microgram per actuation pressurised inhalation, suspension: UK summary of product characteristics. Cambridge: Napp Pharmaceuticals Limited; 2019.Google Scholar
  5. 5.
    Ploszczuk A, Bosheva M, Spooner K, et al. Efficacy and safety of fluticasone propionate/formoterol fumarate in pediatric asthma patients: a randomized controlled trial. Ther Adv Resp Dis. 2018. Scholar
  6. 6.
    Emeryk A, Klink R, McIver T, et al. A 12-week open-label, randomized, controlled trial and 24-week extension to assess the efficacy and safety of fluticasone propionate/formoterol in children with asthma. Ther Adv Respir Dis. 2016;10(4):324–37.CrossRefGoogle Scholar
  7. 7.
    Wolthers OD, Moore A, Mersmann S, et al. Short-term growth during treatment with inhaled fluticasone propionate/formoterol, fluticasone and beclomethasone treatment. J Aerosol Med Pulm Drug Deliv. 2017;30(5):373–80.CrossRefGoogle Scholar
  8. 8.
    Ni Chroinin M, Lasserson TJ, Greenstone I, et al. Addition of long-acting beta-agonists to inhaled corticosteroids for chronic asthma in children. Cochrane Database Syst Rev. 2009;8(3):CD007949.Google Scholar
  9. 9.
    Pohunek P, Kuna P, Jorup C, et al. Budesonide/formoterol improves lung function compared with budesonide alone in children with asthma. Pediatr Allergy Immunol. 2006;17(6):458–65.CrossRefGoogle Scholar
  10. 10.
    Morice AH, Peterson S, Beckman O, et al. Efficacy and safety of a new pressurised metered-dose inhaler formulation of budesonide/formoterol in children with asthma: a superiority and therapeutic equivalence study. Pulm Pharmacol Ther. 2008;21(1):152–9.CrossRefGoogle Scholar
  11. 11.
    Ye Q, He X-O, D’Urzo A. A review on the safety and efficacy of inhaled corticosteroids in the management of asthma. Pulm Ther. 2017;3:1–18.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Springer NatureAucklandNew Zealand

Personalised recommendations