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Eur Respir J. 2015 Apr;45(4):969-79. doi: 10.1183/09031936.00136014. Epub 2015 Jan 8.

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

Author information

1
Pulmonary Department, Mainz University Hospital, Mainz, Germany r.buhl@3-med.klinik.uni-mainz.de.
2
Département de Médecine, Centre de Recherche, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec, Canada.
3
Department of Clinical Research, Morgantown Pulmonary Associates, Morgantown, WV, USA.
4
Department of Respiratory Medicine and Allergology, Lund University, Lund, Sweden.
5
Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.
6
Pulmonary Research Institute of Southeast Michigan, Livonia, MI, USA.
7
Klinika Golnik, Golnik, Slovenia.
8
Department of Medicine, Centre de Recherche Appliquée en Allergie de Québec (CRAAQ), Québec, Canada.
9
Department of Medicine, Centre for Infection and Immunity, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.
10
Department of Pulmonology, NUPAIVA (Asthma Research Centre), Universidade Federal de Santa Catarina, Santa Catarina, Brazil.
11
Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
12
Department of Respiratory Medicine, The Queen Elizabeth Hospital, Adelaide, Australia.
13
Department of Medical Affairs Respiratory, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
14
Medical Department, Boehringer Ingelheim, Burlington, Ontario, Canada.
15
Department of Biostatistics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
16
Department of Medical Affairs Respiratory, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany Department of Sports Medicine, Medical Clinic V, University of Tübingen, Tübingen, Germany.
17
Medical Department, Boehringer Ingelheim B.V., Alkmaar, The Netherlands.
18
Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, Member of the German Center for Lung Research, Grosshansdorf, Germany.
19
Division of Pulmonology, Department of Medicine, University of Cape Town Lung Institute, Cape Town, South Africa.

Abstract

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 μg or 5/5 μg, tiotropium 2.5 μg or 5 μg, or olodaterol 5 μg 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 μg. 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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01431274 NCT01431287.

PMID:
25573406
PMCID:
PMC4391658
DOI:
10.1183/09031936.00136014
[Indexed for MEDLINE]
Free PMC Article

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