A multicenter, randomized, double-blind dose-ranging study of glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler compared to the monocomponents and open-label tiotropium dry powder inhaler in patients with moderate-to-severe COPD
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- 作者：Donald P. Tashkina ; DTashkin@mednet.ucla.edu" class="auth_mail" title="E-mail the corresponding author ; Fernando J. Martinezb ; Roberto Rodriguez-Roisinc ; Charles Fogartyd ; Mark Gotfriede ; Michael Denenbergf ; Gregory Gottschlichg ; James F. Donohueh ; Chad Orevilloi ; Patrick Darkeni ; Earl St Rosei ; Shannon Stromj ; Tracy Fischerj ; Michael Goldenj ; Colin Reisneri
- 关键词：Bronchodilators ; Fixed-dose combinations ; LAMA ; LABA ; Co-Suspension&trade ; Delivery Technology ; COPD maintenance therapy
- 刊名：Respiratory Medicine
- 出版年：2016
- 出版时间：November 2016
- 年：2016
- 卷：120
- 期：Complete
- 页码：16-24
- 全文大小：591 K
文摘
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Of the dose-range evaluated, GFF MDI 18/9.6 μg was the most effective at improving lung function.
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GFF MDI 18/9.6 μg significantly improved FEV1 AUC0−12 vs GP MDI 18 μg, FF MDI 9.6 μg and open-label tiotropium.
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All doses of GFF MDI (except 1.2/9.6 μg) significantly improved FEV1 AUC0–12 vs comparators, in a dose-ordered manner.
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Adverse event profiles were similar across all treatment groups.
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GP 18 μg was determined as the optimal dose to combine with FF MDI 9.6 μg for Phase III trials.