Skip to main content
SpringerLink
Log in

Fluticasone Propionate/Formoterol Fumarate: A Review of Its Use in Persistent Asthma

  • Adis Drug Profile
  • Published:
Drugs Aims and scope Submit manuscript

Abstract

The corticosteroid fluticasone propionate (fluticasone) and the long-acting β2-adrenoceptor agonist formoterol fumarate (formoterol) have been combined in a single, pressurized, metered-dose, aerosol inhaler for the maintenance treatment of patients aged ≥12 years with persistent asthma. This article reviews the clinical efficacy and tolerability of fluticasone/formoterol, with a brief summary of pharmacodynamic and pharmacokinetic properties of the individual drugs. In well designed 8- and 12-week clinical trials in patients with asthma, twice-daily fluticasone/formoterol 100/10, 250/10 (adults and adolescents) or 500/20 μg (adults only) demonstrated rapid and sustained improvements in lung function and asthma control. Improvements achieved with the fixed combination were greater than those achieved with placebo or monotherapy with either of the same respective dosages of fluticasone or formoterol, and similar to those demonstrated when the individual components were administered via separate inhalers concurrently. The efficacy of fluticasone/formoterol was noninferior to that of fluticasone/salmeterol or budesonide/formoterol. Fluticasone/formoterol demonstrated a faster onset of bronchodilation than fluticasone/salmeterol. Fluticasone/formoterol was generally well tolerated, including during treatment periods of up to 12 months. The tolerability profile of fluticasone/formoterol was generally similar to that of fluticasone/salmeterol or budesonide/formoterol.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. British Thoracic Society, Scottish Intercollegiate Guidelines Network. British guideline on the management of asthma: a national clinical guideline. 2008, revised January 2012. http://www.sign.ac.uk/pdf/sign101.pdf. Accessed 7 Jan 2013.

  2. National Health Service Clinical Knowledge Summaries. How common is asthma? 2006. http://www.cks.nhs.uk/asthma/background_information/prevalence. Accessed 21 Dec 2012.

  3. Barnes PJ. Scientific rationale for inhaled combination therapy with long-acting beta2-agonists and corticosteroids. Eur Respir J. 2002;19(1):182–91.

    Article  PubMed  CAS  Google Scholar 

  4. Medicines Compendium UK. Flutiform pressurised inhalation, suspension: summary of product characteristics 2012. http://www.medicines.org.uk/emc/medicine/26954. Accessed 7 Jan 2013.

  5. Holliday SM, Faulds D, Sorkin EM. Inhaled fluticasone propionate: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in asthma. Drugs. 1994;47(2):318–31.

    Article  PubMed  CAS  Google Scholar 

  6. Bartow RA, Brogden RN. Formoterol: an update of its pharmacological properties and therapeutic efficacy in the management of asthma. Drugs. 1998;55(2):303–22.

    Article  PubMed  CAS  Google Scholar 

  7. Hochhaus G, Kaiser K. Comparing the safety and efficacy of fluticasone/formoterol combination therapy in a single inhaler at low and medium doses, with fluticasone and formoterol concurrently or alone, in asthma patients [abstract no. 1549]. Allergy. 2011;66(Suppl. 94):585.

    Google Scholar 

  8. Priestley A, Woodward J, McIver T, et al. Effect of high dose inhaled fluticasone/formoterol combination therapy compared with its separate components on the hypothalamo-pituitary-adrenal (HPA) axis function [abstract no. 1553]. Allergy. 2011;66(Suppl. 94):586.

    Google Scholar 

  9. Tamm M, Kaiser K, Grothe B, et al. Effects on adrenal function of a new combination of fluticasone propionate/formoterol fumarate administered to asthmatic patients and healthy subjects [abstract no. P4010]. 21st Annual Congress of the European Respiratory Society, Amsterdam; 24–28 Sep 2011.

  10. Baljinder J, Howald M, Fischer M, et al. Comparison of the fine particle fraction of fluticasone propionate/formoterol fumarate combination with other combination products [abstract no. P1158]. European Respiratory Society Annual Congress, Vienna; 1–5 Sep, 2012.

  11. Hochhaus G, Kaiser K. Pharmacokinetics of fluticasone/formoterol combination therapy in a single inhaler compared with fluticasone and formoterol concurrently or alone in healthy subjects: results of two open label studies [abstract no. 1550]. Allergy. 2011;66:585.

    Google Scholar 

  12. Corren J, Mansfield LE, Pertseva T, et al. Efficacy and safety of fluticasone/formoterol combination therapy in patients with moderate-to-severe asthma. Resp Med. 2013;107(2):180–95.

    Article  Google Scholar 

  13. Nathan RA, D’Urzo A, Blazhko V, et al. Safety and efficacy of fluticasone/formoterol combination therapy in adolescent and adult patients with mild-to-moderate asthma: a randomised controlled trial. BMC Pulm Med. 2012;18(12):67.

    Article  Google Scholar 

  14. Pearlman DS, Laforce C, Kaiser K. Fluticasone propionate/formoterol fumarate combination therapy has superior efficacy to both fluticasone and formoterol alone [abstract no. P3990]. 21st Annual Congress of the European Respiratory Society, Amsterdam; 24-28 Sep 2011.

  15. Pertseva T, Dissanayake S, Kaiser K. Efficacy and safety of fluticasone/formoterol compared to fluticasone alone in patients with asthma [abstract no. 2191]. European Respiratory Society Annual Congress, Vienna; 1–5 Sep 2012.

  16. Bodzenta-Lukaszyk A, Pulka G, Dymek A, et al. Efficacy and safety of fluticasone and formoterol in a single pressurized metered dose inhaler. Respir Med. 2011;105(5):674–82.

    Article  PubMed  Google Scholar 

  17. Bodzenta-Lukaszyk A, van Noord JA, Schroder-Babo WG, et al. Fluticasone propionate/formoterol fumarate combination therapy has comparable efficacy to its individual components administered concurrently [abstract no. P4007]. 21st Annual Congress of the European Respiratory Society, Amsterdam; 24–28 Sep 2011.

  18. Bodzenta-Lukaszyk A, Dymek A, McAulay K, et al. Fluticasone/formoterol combination therapy is as effective as fluticasone/salmeterol in the treatment of asthma, but has a more rapid onset of action: an open-label, randomized study. BMC Pulm Med. 2011;11:28.

    Article  PubMed  CAS  Google Scholar 

  19. Bodzenta-Lukaszyk A, Buhl R, Balint B, et al. Fluticasone/formoterol combination therapy versus budesonide/ formoterol for the treatment of asthma: a randomized, controlled, non-inferiority trial of efficacy and safety. J Asthma. 2012;. doi:10.3109/02770903.2012.719253.

    PubMed  Google Scholar 

  20. Mansur A, Kaiser K. Long-term safety study and efficacy of futicasone/formoterol combination therapy in asthma. J Aerosol Med Pulm Drug Deliv. 2012. doi:10.1089/jamp.2012.0977.

  21. Price D, Papi A, Kaiser K, et al. Patients with asthma show greater improvements in lung function after combination therapy with fluticasone propionate/formoterol fumarate than with its individual components administered alone [abstract no. 277]. 6th International Primary Care and Respiratory Group World Conference, Edinburgh; 25–28 Apr 2012.

  22. Dissanayake S, Lomax M, Kaiser T, et al. Asthma exacerbation with fluticasone propionate/formoterol fumarate combination therapy versus its individual components [abstract no. P2096]. European Respiatory Society Annual Congress, Vienna; 1–5 Sep 2012.

  23. Price D, Papi A, Kaiser K, et al. Fluticasone propionate/formoterol fumarate combination therapy is equally effective and well-tolerated when administered with or without a spacer device to patients with asthma [abstract no. P3986]. 21st Annual Congress of the European Respiratory Society, Amsterdam; 24–28 Sep 2011.

  24. Aalbers R, Brusselle G, McIver T, et al. Onset of bronchodilation with fluticasone/formoterol combination versus fluticasone/salmeterol in an open-label, randomized study. Adv Therapy. 2012;28(11):958–69.

    Article  Google Scholar 

  25. Harding G, Leidy NK, Meddis D, et al. Interpreting clinical trial results of patient-perceived onset of effect in asthma: methods and results of a Delphi panel. Curr Med Res Opin. 2009;25(6):1563–71.

    Article  PubMed  Google Scholar 

Download references

Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was given the opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.

Author information

Authors and Affiliations

  1. Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand

    Kate McKeage

Authors
  1. Kate McKeage
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Kate McKeage.

Additional information

The manuscript was reviewed by: A. Bodzenta-Lukaszyk, Department of Allergology and Internal Medicine, Medical University of Bialystok, Bialystok, Poland; A. Dymek, Medical Center Lucyna Andrzej Dymek, Strzelce Opolskie, Poland; A.H. Mansur, Severe and Brittle Asthma Unit, Birmingham Heartlands Hospital, Birmingham, UK; D.B. Price, Department of General Practice and Primary Care, University of Aberdeen, Aberdeen, Scotland.

Rights and permissions

Reprints and permissions

About this article

Cite this article

McKeage, K. Fluticasone Propionate/Formoterol Fumarate: A Review of Its Use in Persistent Asthma. Drugs 73, 195–206 (2013). https://doi.org/10.1007/s40265-013-0016-4

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-013-0016-4

Keywords

Search

Navigation