Evidence map›Paper›PMID 25573406›Full record

Trial reportThe European respiratory journal2015

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

Roland Buhl, François Maltais, Roger Abrahams, Leif Bjermer, Eric Derom, Gary Ferguson, Matjaž Fležar, Jacques Hébert, Lorcan McGarvey, Emilio Pizzichini and 9 more

Erratum issuedAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The European respiratory journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 151 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
151citing papers in PubMed, 19 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

151 citing papers in PubMed, 19 syntheses or guidelines pooled it.

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  16. LABA/LAMA fixed-dose combinationsTherapeutic advances in respiratory disease
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  18. LABA/LAMA fixed-dose combinations in patients with COPD: a systematic review.International journal of chronic obstructive pulmonary disease
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  20. Trial

91 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors.

Roland BuhlPulmonary Department, Mainz University Hospital, Mainz, Germany r.buhl@3-med.klinik.uni-mainz.de.
François MaltaisDépartement de Médecine, Centre de Recherche, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec, Canada.
Roger AbrahamsDepartment of Clinical Research, Morgantown Pulmonary Associates, Morgantown, WV, USA.
Leif BjermerDepartment of Respiratory Medicine and Allergology, Lund University, Lund, Sweden.
Eric DeromDepartment of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.
Gary FergusonPulmonary Research Institute of Southeast Michigan, Livonia, MI, USA.
Matjaž FležarKlinika Golnik, Golnik, Slovenia.
Jacques HébertDepartment of Medicine, Centre de Recherche Appliquée en Allergie de Québec (CRAAQ), Québec, Canada.
Lorcan McGarveyDepartment of Medicine, Centre for Infection and Immunity, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.
Emilio PizzichiniDepartment of Pulmonology, NUPAIVA (Asthma Research Centre), Universidade Federal de Santa Catarina, Santa Catarina, Brazil.
Jim ReidDunedin School of Medicine, University of Otago, Dunedin, New Zealand.
Antony VealeDepartment of Respiratory Medicine, The Queen Elizabeth Hospital, Adelaide, Australia.
Lars GrönkeDepartment of Medical Affairs Respiratory, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Alan HamiltonMedical Department, Boehringer Ingelheim, Burlington, Ontario, Canada.
Lawrence KorduckiDepartment of Biostatistics, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
Kay TetzlaffDepartment of Medical Affairs Respiratory, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany Department of Sports Medicine, Medical Clinic V, University of Tübingen, Tübingen, Germany.
Stella Waitere-WijkerMedical Department, Boehringer Ingelheim B.V., Alkmaar, The Netherlands.
Henrik WatzPulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, Member of the German Center for Lung Research, Grosshansdorf, Germany.
Eric BatemanDivision of Pulmonology, Department of Medicine, University of Cape Town Lung Institute, Cape Town, South Africa.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Metered Dose InhalersAdministration, InhalationAgedBenzoxazinesBronchodilator AgentsCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleFollow-Up StudiesHumansInternationalityMaleMaximum Tolerated DoseBenzoxazinesBronchodilator AgentsolodaterolTiotropium Bromide

Identifiers

PMID25573406
PMCPMC4391658

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.