A randomised trial of fluticasone furoate/vilanterol (50/25?¦Ìg; 100/25?¦Ìg) on lung function in COPD

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• 作者：Edward M. Kerwin^a ; ^{ekerwin@allergyasthmaso.com} ; Catherine Scott-Wilson^b ; Lisa Sanford^c ; Stephen Rennard^d ; Alvar Agusti^e ; Neil Barnes^f ; Courtney Crim^b
• 关键词：COPD ; Once-daily ; Lung function ; LABA ; ICS ; Dose-range
• 刊名：Respiratory Medicine
• 出版年：2013
• 出版时间：April, 2013
• 年：2013
• 卷：107
• 期：4
• 页码：560-569
• 全文大小：686 K

文摘

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Summary

Background

Fluticasone furoate (FF)/vilanterol (VI) is a novel once-daily inhaled corticosteroid/long-acting ¦Â₂-agonist combination therapy for COPD. We aimed to assess the efficacy and safety of two strengths of FF/VI (100/25?¦Ìg; 50/25?¦Ìg) vs. individual components (FF 100?¦Ìg, VI 25?¦Ìg) and placebo over 24 weeks.

Methods

Multicentre, randomised, placebo-controlled, double-blind, parallel-group study of patients (N?=?1030) with moderate-to-severe COPD. All medication was administered once daily in the morning. Co-primary efficacy endpoints were: (1) weighted mean (wm) FEV₁ (0-4?h post-dose on day 168) to assess acute lung function effects; and (2) trough FEV₁ (23-24?h post-dose on day 169) to assess long-lasting effects. Symptom-related outcomes were analysed and adverse events (AEs) assessed.

Results

Main findings were: (1) the combination of FF/VI at a strength of 100/25?¦Ìg significantly (p?<?0.001) improved wm FEV₁ (173?ml) and trough FEV₁ (115?ml) vs. placebo. Similar effects were observed with FF/VI 50/25?¦Ìg; (2) no significant difference was seen between FF/VI 100/25?¦Ìg and VI 25?¦Ìg for trough FEV₁ (48?ml, p?=?0.082), while an effect was observed between FF/VI 100/25?¦Ìg and FF 100?¦Ìg for wm FEV₁ (120?ml, p?<?0.001); (3) VI 25?¦Ìg over 24 weeks improved lung function vs. placebo significantly for wm FEV₁ (103?ml, p?<?0.001) and trough FEV₁ (67?ml, p?=?0.017); and (4) no safety signal was observed.

Conclusions

In subjects with moderate-to-severe COPD, FF/VI 100/25?¦Ìg provides rapid and significant sustained bronchodilation at 24 weeks. Lung function is improved to a similar extent with FF/VI 50/25?¦Ìg and to a somewhat lesser extent with VI 25?¦Ìg. All treatments were well tolerated.

GSK study number: HZC112206.

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