Format

Send to

Choose Destination
J Allergy Clin Immunol Pract. 2014 Sep-Oct;2(5):553-61. doi: 10.1016/j.jaip.2014.02.010. Epub 2014 Apr 24.

Fluticasone furoate-vilanterol 100-25 mcg compared with fluticasone furoate 100 mcg in asthma: a randomized trial.

Author information

1
Center for Genomics and Personalized Medicine, Wake Forest School of Medicine, Winston-Salem, NC. Electronic address: ebleeck@wakehealth.edu.
2
Krefting Research Centre, University of Gothenburg, Gothenburg, Sweden.
3
Michael G DeGroote School of Medicine, Hamilton, Ontario, Canada.
4
Institute of Inflammation and Repair, University of Manchester, Manchester, United Kingdom.
5
Department of Medicine, University of Wisconsin, Madison, Wis.
6
Clinical Research Institute of Southern Oregon, PC, Ore.
7
Quantitative Sciences Division, GlaxoSmithKline, RTP, NC.
8
Respiratory Medicines Development Centre, GlaxoSmithKline, London, United Kingdom.
9
Department of Medicine, University of Cape Town, Cape Town, South Africa.

Abstract

BACKGROUND:

The inhaled corticosteroid fluticasone furoate (FF) in combination with the long-acting β2-agonist vilanterol (VI) is under development for the treatment of asthma and chronic obstructive pulmonary disease.

OBJECTIVE:

To compare the efficacy and safety of FF-VI and FF in patients (≥ 12 years old) with persistent asthma.

METHODS:

In a randomized, double-blind, parallel-group study, patients (n = 609) (intent-to-treat population) received FF-VI 100-25 mcg, FF 100 mcg, or placebo once daily (evening) by using a dry powder inhaler for 12 weeks. Coprimary end points were change from baseline in trough FEV1 and serial (0-24 hours) weighted mean FEV1 (wmFEV(1)). Rescue-free 24-hour periods and safety also were assessed.

RESULTS:

Placebo increased trough FEV1 (196 mL) and wmFEV(1) (212 mL) versus baseline. Compared with placebo, FF-VI and FF significantly improved trough FEV1 (172 mL [P < .001] and 136 mL [P = .002]), respectively, and serial wmFEV(1) (302 mL [P < .001] and 186 mL [P = .003]), respectively. Treatment differences between FF-VI and FF approached significance for serial wmFEV(1) (116 mL; P = .060) but not for trough FEV1 (36 mL; P = .405). The percentage of rescue-free 24-hour periods with FF-VI was 10.6% greater than FF and 19.3% greater than placebo. Statistically significant (P = .032) urinary cortisol suppression was observed with FF-VI (ratio, 0.82) relative to placebo, but not with FF. Adverse event and safety profiles were similar across treatment groups.

CONCLUSIONS:

Significant improvement in lung function was observed with FF-VI and FF versus placebo in patients with persistent asthma. Improvement of FEV1 when VI was added to FF was not significant. The high placebo response in evening trough FEV1 may have influenced the assessment of efficacy.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01165138.

KEYWORDS:

Asthma; Efficacy; Fluticasone furoate; Randomized trial; Safety; Tolerability; Vilanterol

PMID:
25213048
DOI:
10.1016/j.jaip.2014.02.010
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center