Efficacy in asthma of once-daily treatment with fluticasone furoate: a randomized, placebo-controlled trial

dc.contributor.authorWoodcock, Ashley
dc.contributor.authorBateman, Eric D
dc.contributor.authorBusse, William W
dc.contributor.authorLötvall, Jan
dc.contributor.authorSnowise, Neil G
dc.contributor.authorForth, Richard
dc.contributor.authorJacques, Loretta
dc.contributor.authorHaumann, Brett
dc.contributor.authorBleecker, Eugene R
dc.date.accessioned2017-11-21T10:42:08Z
dc.date.available2017-11-21T10:42:08Z
dc.date.issued2011-12-01
dc.date.updated2016-10-05T18:05:21Z
dc.description.abstractBackground: Fluticasone furoate (FF) is a novel long-acting inhaled corticosteroid (ICS). This double-blind, placebocontrolled randomized study evaluated the efficacy and safety of FF 200 mcg or 400 mcg once daily, either in the morning or in the evening, and FF 200 mcg twice daily (morning and evening), for 8 weeks in patients with persistent asthma. Methods: Asthma patients maintained on ICS for ≥ 3 months with baseline morning forced expiratory volume in one second (FEV1) 50-80% of predicted normal value and FEV1 reversibility of ≥ 12% and ≥ 200 ml were eligible. The primary endpoint was mean change from baseline FEV1 at week 8 in pre-dose (morning or evening [depending on regimen], pre-rescue bronchodilator) FEV1. Results: A total of 545 patients received one of five FF treatment groups and 101 patients received placebo (intent-to-treat population). Each of the five FF treatment groups produced a statistically significant improvement in pre-dose FEV1 compared with placebo (p < 0.05). FF 400 mcg once daily in the evening and FF 200 mcg twice daily produced similar placebo-adjusted improvements in evening pre-dose FEV1 at week 8 (240 ml vs. 235 ml). FF 400 mcg once daily in the morning, although effective, resulted in a smaller improvement in morning pre-dose FEV1 than FF 200 mcg twice daily at week 8 (315 ml vs. 202 ml). The incidence of oral candidiasis was low (0-4%) and UC excretion was comparable with placebo for all FF groups. Conclusions: FF at total daily doses of 200 mcg or 400 mcg was significantly more effective than placebo. FF 400 mcg once daily in the evening had similar efficacy to FF 200 mcg twice daily and all FF regimens had a safety tolerability profile generally similar to placebo. This indicates that inhaled FF is an effective and well tolerated oncedaily treatment for mild-to-moderate asthma. Trial registration: NCT00398645
dc.identifier.apacitationWoodcock, A., Bateman, E. D., Busse, W. W., Lötvall, J., Snowise, N. G., Forth, R., ... Bleecker, E. R. (2011). Efficacy in asthma of once-daily treatment with fluticasone furoate: a randomized, placebo-controlled trial. <i>Respiratory Research</i>, http://hdl.handle.net/11427/26409en_ZA
dc.identifier.chicagocitationWoodcock, Ashley, Eric D Bateman, William W Busse, Jan Lötvall, Neil G Snowise, Richard Forth, Loretta Jacques, Brett Haumann, and Eugene R Bleecker "Efficacy in asthma of once-daily treatment with fluticasone furoate: a randomized, placebo-controlled trial." <i>Respiratory Research</i> (2011) http://hdl.handle.net/11427/26409en_ZA
dc.identifier.citationRespiratory Research. 2011 Dec 01;12(1):132
dc.identifier.ris TY - Journal Article AU - Woodcock, Ashley AU - Bateman, Eric D AU - Busse, William W AU - Lötvall, Jan AU - Snowise, Neil G AU - Forth, Richard AU - Jacques, Loretta AU - Haumann, Brett AU - Bleecker, Eugene R AB - Background: Fluticasone furoate (FF) is a novel long-acting inhaled corticosteroid (ICS). This double-blind, placebocontrolled randomized study evaluated the efficacy and safety of FF 200 mcg or 400 mcg once daily, either in the morning or in the evening, and FF 200 mcg twice daily (morning and evening), for 8 weeks in patients with persistent asthma. Methods: Asthma patients maintained on ICS for ≥ 3 months with baseline morning forced expiratory volume in one second (FEV1) 50-80% of predicted normal value and FEV1 reversibility of ≥ 12% and ≥ 200 ml were eligible. The primary endpoint was mean change from baseline FEV1 at week 8 in pre-dose (morning or evening [depending on regimen], pre-rescue bronchodilator) FEV1. Results: A total of 545 patients received one of five FF treatment groups and 101 patients received placebo (intent-to-treat population). Each of the five FF treatment groups produced a statistically significant improvement in pre-dose FEV1 compared with placebo (p < 0.05). FF 400 mcg once daily in the evening and FF 200 mcg twice daily produced similar placebo-adjusted improvements in evening pre-dose FEV1 at week 8 (240 ml vs. 235 ml). FF 400 mcg once daily in the morning, although effective, resulted in a smaller improvement in morning pre-dose FEV1 than FF 200 mcg twice daily at week 8 (315 ml vs. 202 ml). The incidence of oral candidiasis was low (0-4%) and UC excretion was comparable with placebo for all FF groups. Conclusions: FF at total daily doses of 200 mcg or 400 mcg was significantly more effective than placebo. FF 400 mcg once daily in the evening had similar efficacy to FF 200 mcg twice daily and all FF regimens had a safety tolerability profile generally similar to placebo. This indicates that inhaled FF is an effective and well tolerated oncedaily treatment for mild-to-moderate asthma. Trial registration: NCT00398645 DA - 2011-12-01 DB - OpenUCT DO - 10.1186/1465-9921-12-132 DP - University of Cape Town J1 - Respiratory Research LK - https://open.uct.ac.za PB - University of Cape Town PY - 2011 T1 - Efficacy in asthma of once-daily treatment with fluticasone furoate: a randomized, placebo-controlled trial TI - Efficacy in asthma of once-daily treatment with fluticasone furoate: a randomized, placebo-controlled trial UR - http://hdl.handle.net/11427/26409 ER - en_ZA
dc.identifier.urihttp://dx.doi.org/10.1186/1465-9921-12-132
dc.identifier.urihttp://hdl.handle.net/11427/26409
dc.identifier.vancouvercitationWoodcock A, Bateman ED, Busse WW, Lötvall J, Snowise NG, Forth R, et al. Efficacy in asthma of once-daily treatment with fluticasone furoate: a randomized, placebo-controlled trial. Respiratory Research. 2011; http://hdl.handle.net/11427/26409.en_ZA
dc.language.rfc3066en
dc.publisherBioMed Central
dc.publisher.departmentDepartment of Medicineen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rights.holderWoodcock et al; licensee BioMed Central Ltd.
dc.rights.urihttps://creativecommons.org/licenses/by/2.0/
dc.sourceRespiratory Research
dc.source.urihttps://respiratory-research.biomedcentral.com/
dc.subject.otheronce-daily
dc.subject.otherICS
dc.subject.otherasthma
dc.titleEfficacy in asthma of once-daily treatment with fluticasone furoate: a randomized, placebo-controlled trial
dc.typeJournal Article
uct.type.filetypeText
uct.type.filetypeImage
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