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

Simple item page
dc.contributor.authorWoodcock, Ashleyen_ZA
dc.contributor.authorBateman, Eric Den_ZA
dc.contributor.authorBusse, William Wen_ZA
dc.contributor.authorLotvall, Janen_ZA
dc.contributor.authorSnowise, Neil Gen_ZA
dc.contributor.authorForth, Richarden_ZA
dc.contributor.authorJacques, Lorettaen_ZA
dc.contributor.authorHaumann, Bretten_ZA
dc.contributor.authorBleecker, Eugene Ren_ZA
dc.date.accessioned2015-11-18T04:01:18Z
dc.date.available2015-11-18T04:01:18Z
dc.date.issued2011en_ZA
dc.description.abstractBACKGROUND: Fluticasone furoate (FF) is a novel long-acting inhaled corticosteroid (ICS). This double-blind, placebo-controlled 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 [greater than or equal to] 3 months with baseline morning forced expiratory volume in one second (FEV1) 50-80% of predicted normal value and FEV1 reversibility of [greater than or equal to] 12% and [greater than or equal to] 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 once-daily treatment for mild-to-moderate asthma.TRIAL REGISTRATION:NCT00398645en_ZA
dc.identifier.apacitationWoodcock, A., Bateman, E. D., Busse, W. W., Lotvall, 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/11427/15097en_ZA
dc.identifier.chicagocitationWoodcock, Ashley, Eric D Bateman, William W Busse, Jan Lotvall, 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/11427/15097en_ZA
dc.identifier.citationWoodcock, 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. Respir Res, 12(1), 132.en_ZA
dc.identifier.ris TY - Journal Article AU - Woodcock, Ashley AU - Bateman, Eric D AU - Busse, William W AU - Lotvall, 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, placebo-controlled 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 [greater than or equal to] 3 months with baseline morning forced expiratory volume in one second (FEV1) 50-80% of predicted normal value and FEV1 reversibility of [greater than or equal to] 12% and [greater than or equal to] 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 once-daily treatment for mild-to-moderate asthma.TRIAL REGISTRATION:NCT00398645 DA - 2011 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/11427/15097 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/15097
dc.identifier.urihttp://dx.doi.org/10.1186/1465-9921-12-132
dc.identifier.vancouvercitationWoodcock A, Bateman ED, Busse WW, Lotvall 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/11427/15097.en_ZA
dc.language.isoengen_ZA
dc.publisherBioMed Central Ltden_ZA
dc.publisher.departmentDepartment of Medicineen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution Licenseen_ZA
dc.rights.holder2011 Woodcock et al; licensee BioMed Central Ltd.en_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en_ZA
dc.sourceRespiratory Researchen_ZA
dc.source.urihttp://www.respiratory-research.com/en_ZA
dc.subject.otherOnce-dailyen_ZA
dc.subject.otherICSen_ZA
dc.subject.otherAsthmaen_ZA
dc.titleEfficacy in asthma of once-daily treatment with fluticasone furoate: a randomized, placebo-controlled trialen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
Woodcock_Efficacy_in_asthma_2011.pdf
Size:
379.02 KB
Format:
Adobe Portable Document Format
Description:
Download
Collections
Journal Articles