Dose effect of once-daily fluticasone furoate in persistent asthma: A randomized trial

Eric D. Bateman; Eugene R. Bleecker; Jan Lötvall; Ashley Woodcock; Richard Forth; Hilary Medley; Angela M. Davis; Loretta Jacques; Brett Haumann; William W. Busse

doi:10.1016/j.rmed.2012.01.004

Dose effect of once-daily fluticasone furoate in persistent asthma: A randomized trial

Eric D. Bateman, Eugene R. Bleecker, Jan Lötvall, Ashley Woodcock, Richard Forth, Hilary Medley, Angela M. Davis, Loretta Jacques, Brett Haumann, William W. Busse

Research output: Contribution to journal › Article › peer-review

64 Scopus citations

Abstract

Background: This randomized, double-blind, multicenter study was designed to evaluate the efficacy of inhaled once-daily fluticasone furoate (FF) administered in the evening in patients with persistent asthma not controlled by short-acting beta ₂ agonists, and to determine the dose(s) suitable for further development. Methods: Of 1459 patients screened, 598 received one of six treatments: placebo, FF (25 μg, 50 μg, 100 μg or 200 μg) once daily each evening, or fluticasone propionate (FP) 100 μg twice daily for 8 weeks. The primary endpoint was change from baseline in pre-dose evening forced expiratory volume in 1 s (FEV ₁). Results: A dose-response effect was observed for once-daily FF 25-200 μg including (p < 0.001) and excluding placebo (p = 0.03). FF 50-200 μg once daily significantly increased FEV ₁ from baseline (p < 0.05 vs placebo), by >200 mL for FF 100 μg and 200 μg. Significant improvements were also achieved for peak expiratory flow, and percentage symptom-free and rescue-free 24 h periods. The magnitude of effect was at least as good as twice-daily FP. Overall, once-daily FF was well tolerated with no systemic corticosteroid effects. Conclusion: FF 50-200 μg/day once daily in the evening demonstrated dose-related efficacy in asthma with 100-200 μg appearing to be the optimal doses for further evaluation.

Original language	English (US)
Pages (from-to)	642-650
Number of pages	9
Journal	Respiratory Medicine
Volume	106
Issue number	5
DOIs	https://doi.org/10.1016/j.rmed.2012.01.004
State	Published - May 2012
Externally published	Yes

Keywords

Asthma
Dose-response
Evening dosing
Fluticasone furoate
Inhaled corticosteroids
Once-daily dosing

ASJC Scopus subject areas

Pulmonary and Respiratory Medicine

Access to Document

10.1016/j.rmed.2012.01.004

Cite this

@article{c537e15aa3e948768d7b119e8698d4d9,

title = "Dose effect of once-daily fluticasone furoate in persistent asthma: A randomized trial",

abstract = "Background: This randomized, double-blind, multicenter study was designed to evaluate the efficacy of inhaled once-daily fluticasone furoate (FF) administered in the evening in patients with persistent asthma not controlled by short-acting beta 2 agonists, and to determine the dose(s) suitable for further development. Methods: Of 1459 patients screened, 598 received one of six treatments: placebo, FF (25 μg, 50 μg, 100 μg or 200 μg) once daily each evening, or fluticasone propionate (FP) 100 μg twice daily for 8 weeks. The primary endpoint was change from baseline in pre-dose evening forced expiratory volume in 1 s (FEV 1). Results: A dose-response effect was observed for once-daily FF 25-200 μg including (p < 0.001) and excluding placebo (p = 0.03). FF 50-200 μg once daily significantly increased FEV 1 from baseline (p < 0.05 vs placebo), by >200 mL for FF 100 μg and 200 μg. Significant improvements were also achieved for peak expiratory flow, and percentage symptom-free and rescue-free 24 h periods. The magnitude of effect was at least as good as twice-daily FP. Overall, once-daily FF was well tolerated with no systemic corticosteroid effects. Conclusion: FF 50-200 μg/day once daily in the evening demonstrated dose-related efficacy in asthma with 100-200 μg appearing to be the optimal doses for further evaluation.",

keywords = "Asthma, Dose-response, Evening dosing, Fluticasone furoate, Inhaled corticosteroids, Once-daily dosing",

author = "Bateman, {Eric D.} and Bleecker, {Eugene R.} and Jan L{\"o}tvall and Ashley Woodcock and Richard Forth and Hilary Medley and Davis, {Angela M.} and Loretta Jacques and Brett Haumann and Busse, {William W.}",

note = "Funding Information: This study was supported by GlaxoSmithKline (study code FFA109687; ClinicalTrials.gov NCT00603382). ",

year = "2012",

month = may,

doi = "10.1016/j.rmed.2012.01.004",

language = "English (US)",

volume = "106",

pages = "642--650",

journal = "Respiratory Medicine",

issn = "0954-6111",

publisher = "W.B. Saunders Ltd",

number = "5",

}

TY - JOUR

T1 - Dose effect of once-daily fluticasone furoate in persistent asthma

T2 - A randomized trial

AU - Bateman, Eric D.

AU - Bleecker, Eugene R.

AU - Lötvall, Jan

AU - Woodcock, Ashley

AU - Forth, Richard

AU - Medley, Hilary

AU - Davis, Angela M.

AU - Jacques, Loretta

AU - Haumann, Brett

AU - Busse, William W.

N1 - Funding Information: This study was supported by GlaxoSmithKline (study code FFA109687; ClinicalTrials.gov NCT00603382).

PY - 2012/5

Y1 - 2012/5

N2 - Background: This randomized, double-blind, multicenter study was designed to evaluate the efficacy of inhaled once-daily fluticasone furoate (FF) administered in the evening in patients with persistent asthma not controlled by short-acting beta 2 agonists, and to determine the dose(s) suitable for further development. Methods: Of 1459 patients screened, 598 received one of six treatments: placebo, FF (25 μg, 50 μg, 100 μg or 200 μg) once daily each evening, or fluticasone propionate (FP) 100 μg twice daily for 8 weeks. The primary endpoint was change from baseline in pre-dose evening forced expiratory volume in 1 s (FEV 1). Results: A dose-response effect was observed for once-daily FF 25-200 μg including (p < 0.001) and excluding placebo (p = 0.03). FF 50-200 μg once daily significantly increased FEV 1 from baseline (p < 0.05 vs placebo), by >200 mL for FF 100 μg and 200 μg. Significant improvements were also achieved for peak expiratory flow, and percentage symptom-free and rescue-free 24 h periods. The magnitude of effect was at least as good as twice-daily FP. Overall, once-daily FF was well tolerated with no systemic corticosteroid effects. Conclusion: FF 50-200 μg/day once daily in the evening demonstrated dose-related efficacy in asthma with 100-200 μg appearing to be the optimal doses for further evaluation.

AB - Background: This randomized, double-blind, multicenter study was designed to evaluate the efficacy of inhaled once-daily fluticasone furoate (FF) administered in the evening in patients with persistent asthma not controlled by short-acting beta 2 agonists, and to determine the dose(s) suitable for further development. Methods: Of 1459 patients screened, 598 received one of six treatments: placebo, FF (25 μg, 50 μg, 100 μg or 200 μg) once daily each evening, or fluticasone propionate (FP) 100 μg twice daily for 8 weeks. The primary endpoint was change from baseline in pre-dose evening forced expiratory volume in 1 s (FEV 1). Results: A dose-response effect was observed for once-daily FF 25-200 μg including (p < 0.001) and excluding placebo (p = 0.03). FF 50-200 μg once daily significantly increased FEV 1 from baseline (p < 0.05 vs placebo), by >200 mL for FF 100 μg and 200 μg. Significant improvements were also achieved for peak expiratory flow, and percentage symptom-free and rescue-free 24 h periods. The magnitude of effect was at least as good as twice-daily FP. Overall, once-daily FF was well tolerated with no systemic corticosteroid effects. Conclusion: FF 50-200 μg/day once daily in the evening demonstrated dose-related efficacy in asthma with 100-200 μg appearing to be the optimal doses for further evaluation.

KW - Asthma

KW - Dose-response

KW - Evening dosing

KW - Fluticasone furoate

KW - Inhaled corticosteroids

KW - Once-daily dosing

UR - http://www.scopus.com/inward/record.url?scp=84859110112&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84859110112&partnerID=8YFLogxK

U2 - 10.1016/j.rmed.2012.01.004

DO - 10.1016/j.rmed.2012.01.004

M3 - Article

C2 - 22342538

AN - SCOPUS:84859110112

SN - 0954-6111

VL - 106

SP - 642

EP - 650

JO - Respiratory Medicine

JF - Respiratory Medicine

IS - 5

ER -

Dose effect of once-daily fluticasone furoate in persistent asthma: A randomized trial

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this