Fluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100 mcg) in persistent asthma

Abstract

Objectives: Fluticasone furoate (FF; inhaled corticosteroid) combined with vilanterol (VI; long-acting beta₂ agonist) is a once-daily therapy for asthma and chronic obstructive pulmonary disease. This 12-week phase III study compared the efficacy and safety of once-daily (evening dosing) FF/VI 100/25 mcg versus FF 100 mcg (primary objective) and FF/VI 100/25 mcg versus FF/VI 200/25 mcg (descriptive comparison only) in patients (n = 1039) ≥12 years with moderate-to-severe persistent asthma. Methods: The primary end point was weighted mean (wm) 0–24-h serial forced expiratory volume in 1 s (FEV₁) at week 12. Secondary end points (change from baseline) were trough FEV₁ and the proportion (%) of rescue-free 24-h periods (both powered), the proportion (%) of symptom-free 24-h periods, and morning and evening peak expiratory flow (PEF). Safety data (adverse events, AEs) were collected throughout. Results: Compared with FF 100 mcg, FF/VI 100/25 mcg significantly improved wmFEV₁ (p < 0.001), trough FEV₁ (p = 0.014), % rescue-free (p < 0.001), % symptom-free (p = 0.002) 24-h periods, and morning and evening PEF (p < 0.001). FF/VI 200/25 mcg produced small numerical improvements versus FF/VI 100/25 mcg for all end points. Incidence of AEs was similar across groups. Conclusions: FF/VI 100/25 mcg resulted in significant improvements in all primary and secondary end points versus FF 100 mcg. Numerical improvements occurred with FF/VI 200/25 mcg versus FF/VI 100/25 mcg. All treatments were well tolerated.

• Efficacy
• inhaled corticosteroid
• long-acting beta-agonist
• lung function
• safety

Acknowledgements

We thank all patients and investigators involved in this study. Editorial support in the form of development of the draft outline and manuscript first draft in consultation with the authors was provided by Jackie Phillipson, PhD at Gardiner-Caldwell Communications (Macclesfield, UK), and editorial suggestions to draft versions of this paper, assembling tables and figures, collating author comments, copyediting, fact checking, referencing and graphic services were provided by Laura Maguire, MChem at Gardiner-Caldwell Communications (Macclesfield, UK).

Declaration of interest

Editorial support was funded by GSK. Professor D. I. Bernstein has received research support from the American Academy of Allergy, Asthma, and Immunology/American College of Allergy, Asthma, and Immunology, National Institutes of Health and National Institute for Occupational Safety and Health-Centers for Disease Control; has received consultancy and lecture fees and travel support from Merck; is on the Merck Scientific Advisory Committee; is on the American Board of Allergy and Immunology; has provided expert testimony for Porter Wright, LLC, as a medical expert; has received payment for the development of educational presentations from the Merck Advisory Board; and has received grants from Amgen, AstraZeneca, Johnson & Johnson, MedImmune, Novartis, Pfizer, and TEVA for the conduct of clinical asthma trials. Prof. E. D. Bateman has served as a consultant for Actelion, AlkAbello, Almirall, Cephalon, Hoffman la Roche, ICON, IMS Consulting Group, and Navigant Consulting; been on advisory boards for Almirall, AstraZeneca, Boehringer Ingelheim, Elevation Pharma, Forest, GSK, Merck, Napp, Novartis, Pfizer, and Takeda; and received lecture fees from AlkAbello, AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Merck, Novartis, Pfizer, Nycomed and Takeda; and received payment for development of teaching materials for Indegene Lifesciences Ltd; and his institution has received remuneration for participation in clinical trials sponsored by Actelion, Aeras, Almirall, AstraZeneca, Boehringer Ingelheim, Cephalon, Chiesi, Forest, GSK, Hoffman La Roche, Merck, Novartis, Nycomed, Takeda and TEVA. Professor A. Woodcock has served as consultant to Almirall, Cytos, Chiesi, and GSK; and has received lecture fees and research grants from GSK. Mr. R. Forth, and Drs. W. T. Toler, L. Jacques and C. Nunn are employees of and hold stock in GSK. Prof. P. M. O’Byrne has served as a consultant to Almirall, AstraZeneca, Chiesi and Novartis; has served on advisory boards for AIM, Altair, Boehringer Ingelheim, GSK, Medimmune and Merck; has received lecture fees from Chiesi; and has received research funding from AstraZeneca, Asmacure, Altair, Amgen, Genentech, Topigen and Wyeth. The study was sponsored by GSK (study number HZA116863; www.clinicaltrials.gov registration number NCT01686633). Employees of the sponsor were involved in the conception, design and conduct of the study, and in data collection and analysis. All authors, including authors employed by the sponsor, participated in the development of the manuscript, and had access to the data from the study. The decision to submit for publication was that of the authors alone.

Supplementary material available online

Supplementary Tables 1-4 and Figures S1-S3.

Notes

¹ELLIPTA^® is a trademark of the GSK group of companies.