Fluticasone propionate/formoterol fumarate in fixed-dose combination for the treatment of asthma

Abstract

A new combination inhaler containing fluticasone, a potent inhaled corticosteroid (ICS), and formoterol, a long-acting β-agonist (LABA) with rapid onset and sustained bronchodilator effect, has been approved for treatment of persistent asthma in patients ≥12 years of age requiring combination ICS-LABA therapy. The fluticasone/formoterol combination, delivered via pressurized metered-dose inhaler and available in three dose strengths, has demonstrated a good safety and tolerability profile in trials of up to 1 year. The efficacy of fluticasone/formoterol is greater than that of fluticasone or formoterol alone and noninferior to that of fluticasone/salmeterol and budesonide/formoterol in tightly controlled 8–12-week clinical trials. Advantages of the fluticasone/formoterol combination aerosol include rapid onset of bronchodilation, an attribute preferred by patients, and emission of a high fine-particle fraction that is consistent at different flow rates, which may aid consistency of delivery (given patient variability in inhalation maneuvers) and provide real-life benefits.

Keywords::

• anti-inflammatory
• asthma
• bronchodilator
• fluticasone propionate
• formoterol fumarate
• inhaled corticosteroid
• long-acting β-agonist

Acknowledgements

The writing of this review was supported by an unrestricted grant from Mundipharma, which had no input other than the provision of relevant information into the content.

Financial & competing interests disclosure

D Price has served on the boards of Almirral, Astra Zeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Merck, Mundipharma, Medapharma, Novartis, Napp, Nycomed, Pfizer, Sandoz, and Teva. D Price has been a consultant for Almirral, Astra Zeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Merck, Mundipharma, Medapharma, Novartis, Napp, Nycomed, Pfizer, Sandoz, and Teva. D Price has received/will receive grants from UK National Health Service, Aerocrine, Astra Zeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Meda, Merck, Mundipharma, Novartis, Nycomed, Orion, Pfizer, Takeda, Teva, and Zentiva. D Price has received payments for lectures/speaking from Almirral, AstraZeneca, Activaero, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Novartis, Medapharma, Merck, Mundipharma, Pfizer Takeda, and Teva. D Price has received payment for manuscript preparation from Merck, Mundipharma, and Teva. D Price has patents (planned, pending, or issued) for AKL Ltd. D Price has received payment for the development of educational materials from GlaxoSmithKline. D Price has shares in AKL Ltd, which produces phytopharmaceuticals, and owns 80% of Research in Real Life Ltd and its subsidiary social enterprise Optimum Patient Care. D Price has received payment for travel/accommodations/meeting expenses from Aerocrine, Boehringer Ingelheim, Napp, Novartis, Mundipharma, and Teva. D Price has received funding for patient enrolment or completion of research from Chiesi, Almirall, Zentiva, and Teva. D Price has been a peer reviewer for grant committees Medical Research Council (2012), Efficacy and Mechanism Evaluation programme (2012), HTA (2012). EV Hillyer is a consultant for Research in Real Life, Ltd, and has received payment for manuscript preparation from Merck and TevaFrance. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• A fixed-dose combination of fluticasone/formoterol is now available via pressurized metered-dose inhaler (pMDI) for regular treatment of asthma for adults and adolescents when the use of a combination product (an inhaled corticosteroid and long-acting β-agonist) is appropriate.

• Clinical trial results indicate that the efficacy of the fluticasone/formoterol combination over 8–12 weeks is greater than that of fluticasone or formoterol alone and noninferior to that of combination products containing fluticasone/salmeterol and budesonide/formoterol.

• The safety and tolerability of fluticasone/formoterol was demonstrated for the 250/10 μg and 100/10 μg doses administered twice daily for up to 1 year.

• Advantages of the fluticasone/formoterol combination aerosol include rapid onset of bronchodilation and a high fine-particle fraction that is consistent at different flow rates in laboratory testing.

• The fluticasone/formoterol combination is an efficacious option for patients requiring an inhaled corticosteroid and long-acting β-agonist in combination for their asthma, particularly for those already accustomed to a pMDI and using reliever therapy via pMDI.

Notes