A review of the efficacy and safety of fluticasone propionate/formoterol fixed-dose combination

ABSTRACT

Introduction

Fluticasone propionate/formoterol fumarate (FP/FORM) is one of the newer combinations among inhaled corticosteroid (ICS) and long-acting β2-agonist (LABA) combination formulations currently available. To evaluate the efficacy and safety of this FP/FORM combination, it is important to review all the available evidence and take a comprehensive look at the current and relevant data in the patient population suffering from asthma and chronic obstructive pulmonary disease (COPD).

Areas covered

In this focused review, we summarize the available literature published until January 2021 using the PubMed/Medline and Cochrane Controlled Trials Register databases on the efficacy and safety of FP/FORM with its mono-components; concurrent administration of FP+FORM; and with other ICS/LABA combinations in asthma and COPD patients.

Expert opinion

FP/FORM combination therapy is a strong alternative in the treatment of persistent asthma and moderate-severe COPD. Extensive study of several trials has established the superior efficacy of FP/FORM combination therapy over FP or FORM monotherapy, comparable efficacy with FP+FORM and non-inferiority to other ICS/LABA fixed-dose combinations. The safety profile of FP/FORM has also been found to be comparable with respect to its mono-components and their concurrent use, and also other ICS/LABA combinations such as formoterol/budesonide and fluticasone/salmeterol.

KEYWORDS:

• Asthma
• chronic obstructive pulmonary disease
• fluticasone
• formoterol
• inhaled corticosteroid
• long-acting β2-agonists
• ICS-LABA

Article highlights

• Asthma and chronic obstructive pulmonary disease (COPD) are the most common chronic respiratory diseases posing a global public health concern.

• Fixed-dose combination of Inhaled corticosteroids (ICS) and long-acting β2-agonists (LABAs) has revolutionized the treatment of asthma and found to be more effective than ICS and LABA monotherapy in selected patients with moderate-to-very severe COPD.

• Fluticasone propionate (FP) and formoterol fumarate (FORM) fixed-dose combination has emerged as a newer and stronger option to optimize disease control in asthma and COPD patients.

• FP/FORM combination has demonstrated efficacy with respect to improving disease control, lung function, and symptom-free days.

• FP/FORM combination at various doses has demonstrated significant improvement in change in pre-dose FEV₁ and 2 hours post-dose FEV1 measurements from baseline compared with its mono-components.

• Safety and tolerability data has shown that the FP/FORM combination therapy is safe to administer in pediatric, adult, and adolescent patients with a diagnosis of asthma and COPD.

Acknowledgments

Ms. Sushmeeta Chhowala and Dr. Priyanka Mukherjee reviewed earlier versions of the manuscript.

Declaration of interests

S. Kilaru, and A. Bansal have no conflict of interests. V. Naik, M. Lopez, and J. Gogtay are employees of Cipla Ltd. 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 apart from those disclosed.

Reviewer disclosures

One reviewer has performed consulting, served on advisory boards, or received travel reimbursement from Amphastar, AstraZeneca, Chiesi, Connect Biopharma, GlaxoSmithKline, Mylan, Novartis, Sunovion, and Theravance. They have also conducted multicenter clinical research trials for some 40 pharmaceutical companies. The other peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

Writing assistance was contracted to IntelliMed Healthcare Solutions and funded by Cipla Ltd., India. The authors received no direct compensation related to the development of the manuscript. The authors were fully responsible for all content and were involved at all stages of development and provided their approval on the final version. Cipla Ltd. was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.