Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4)

被引：268

作者：

Buhl, Roland ^{[1
]}

Maltais, Francois ^{[2
]}

Abrahams, Roger ^{[3
]}

Bjermer, Leif ^{[4
]}

Derom, Eric ^{[5
]}

Ferguson, Gary ^{[6
]}

Flezar, Matjaz ^{[7
]}

Hebert, Jacques ^{[8
]}

McGarvey, Lorcan ^{[9
]}

Pizzichini, Emilio ^{[10
]}

Reid, Jim ^{[11
]}

Veale, Antony ^{[12
]}

Groenke, Lars ^{[13
]}

Hamilton, Alan ^{[14
]}

Korducki, Lawrence ^{[15
]}

Tetzlaff, Kay ^{[13
,16
]}

Waitere-Wijker, Stella ^{[17
]}

Watz, Henrik ^{[18
]}

Bateman, Eric ^{[19
]}

机构：

[1] Mainz Univ Hosp, Dept Pulm, D-55131 Mainz, Germany

[2] Inst Univ Cardiol & Pneumol Quebec, Dept Med, Ctr Rech, Quebec City, PQ, Canada

[3] Morgantown Pulm Associates, Dept Clin Res, Morgantown, WV USA

[4] Lund Univ, Dept Resp Med & Allergol, Lund, Sweden

[5] Ghent Univ Hosp, Dept Resp Med, Ghent, Belgium

[6] Pulm Res Inst Southeast Michigan, Livonia, MI USA

[7] Klin Golnik, Golnik, Slovenia

[8] Ctr Rech Appl Allergie Quebec, Dept Med, Quebec City, PQ, Canada

[9] Queens Univ Belfast, Dept Med, Ctr Infect & Immun, Sch Med Dent & Biomed Sci, Belfast, Antrim, North Ireland

[10] Univ Fed Santa Catarina, NUPAIVA Asthma Res Ctr, Dept Pulmonol, BR-88040900 Florianopolis, SC, Brazil

[11] Univ Otago, Dunedin Sch Med, Dunedin, New Zealand

[12] Queen Elizabeth Hosp, Dept Resp Med, Adelaide, SA, Australia

[13] Boehringer Ingelheim Pharma GmbH & Co KG, Dept Med Affairs Resp, Ingelheim, Germany

[14] Boehringer Ingelheim GmbH & Co KG, Dept Med, Burlington, ON, Canada

[15] Boehringer Ingelheim Pharmaceut Inc, Dept Biostat, Ridgefield, CT 06877 USA

[16] Univ Tubingen, Dept Sports Med, Med Clin 5, Tubingen, Germany

[17] Boehringer Ingelheim BV, Dept Med, Alkmaar, Netherlands

[18] Airway Res Ctr North, Pulm Res Inst, Lung Clin Grosshansdorf, Grosshansdorf, Germany

[19] Univ Cape Town, Dept Med, Div Pulmonol, Lung Inst, ZA-7925 Cape Town, South Africa

来源：

EUROPEAN RESPIRATORY JOURNAL | 2015年 / 45卷 / 04期

关键词：

D O I：

10.1183/09031936.00136014

中图分类号：

R56 [呼吸系及胸部疾病];

学科分类号：

摘要：

Efficacy and safety of tiotropium+olodaterol fixed-dose combination (FDC) compared with the mono-components was evaluated in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) in two replicate, randomised, double-blind, parallel-group, multicentre, phase III trials. Patients received tiotropium+ olodaterol FDC 2.5/5 mu g or 5/5 mu g, tiotropium 2.5 mu g or 5 mu g, or olodaterol 5 mu g delivered once-daily via Respimat inhaler over 52 weeks. Primary end points were forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC0-3) response, trough FEV1 response and St George's Respiratory Questionnaire (SGRQ) total score at 24 weeks. In total, 5162 patients (2624 in Study 1237.5 and 2538 in Study 1237.6) received treatment. Both FDCs significantly improved FEV1 AUC0-3 and trough FEV1 response versus the mono-components in both studies. Statistically significant improvements in SGRQ total score versus the mono-components were only seen for tiotropium+ olodaterol FDC 5/5 mu g. Incidence of adverse events was comparable between the FDCs and the mono-components. These studies demonstrated significant improvements in lung function and health-related quality of life with once-daily tiotropium+ olodaterol FDC versus mono-components over 1 year in patients with moderate to very severe COPD.

引用

页码：969 / 979

页数：11

共 27 条

[1]

Aalbers R, 2012, EUR RESP J S56, V40, P2882

[2]

[Anonymous], 2016, Fact Sheet

[3] A one-year trial of tiotropium Respimat® plus usual therapy in COPD patients [J].