Evidence map›Paper›PMID 29439648›Full record

Trial reportTherapeutic advances in respiratory disease

Effect of 12 weeks of once-daily tiotropium/olodaterol on exercise endurance during constant work-rate cycling and endurance shuttle walking in chronic obstructive pulmonary disease.

François Maltais, Denis O'Donnell, Juan Bautista Gáldiz Iturri, Anne-Marie Kirsten, Dave Singh, Alan Hamilton, Kay Tetzlaff, Yihua Zhao, Richard Casaburi

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Therapeutic advances in respiratory disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01525615 (A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Effect of 12 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination), which is not on this map. Cited by 22 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 4 pooled it
4.2field-weighted citation impact, top 5% of its field
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.

NCT01525615 phase3completednot on this map

A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Effect of 12 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg and 5/5 µg) Delivered by the Respimat® Inhaler, on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD)[Torracto (TM)]

TypeinterventionalSponsorBoehringer IngelheimRan2012 to 2013Enrolled404ConditionsPulmonary Disease, Chronic ObstructiveArmsRespimat inhaler, tiotropium+olodaterol (low dose), tiotropium + olodaterol (high dose), placebo to tiotropium+olodaterol
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 4 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Fixed-intensity exercise tests to measure exertional dyspnoea in chronic heart and lung populations: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2023
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  18. A Post Hoc Holter ECG Analysis of Olodaterol and Formoterol in Moderate-to-Very-Severe COPD.International journal of chronic obstructive pulmonary disease · 2020
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  20. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 9 institutions in 5 countries.

François MaltaisInstitut universitaire de cardiologie et de pneumologie de Québec, Université Laval, 2725 Chemin Sainte-Foy, Québec, QC G1V 4G5, Canada.
Denis O'DonnellDivision of Respiratory Medicine, Department of Medicine, Queen's University and Kingston General Hospital, Kingston, Ontario, Canada.
Juan Bautista Gáldiz IturriBioCruces Health Research Institute, Barakaldo, Spain.
Anne-Marie KirstenPulmonary Research Institute at LungClinic Grosshansdorf, Airway Research Center North, Grosshansdorf, Germany.
Dave SinghMedicines Evaluation Unit, University of Manchester, Manchester, UK.
Alan HamiltonBoehringer Ingelheim, Burlington, Ontario, Canada.
Kay TetzlaffBoehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, and Department of Sports Medicine, University of Tübingen, Tübingen, Germany.
Yihua ZhaoBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
Richard CasaburiLos Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.
BioCruces Health research Institute · ESBoehringer Ingelheim (Canada) · CABoehringer Ingelheim (United States) · USHarbor–UCLA Medical Center · USInstitut Universitaire de Cardiologie et de Pneumologie de Québec · CAKingston General Hospital · CALungenClinic Grosshansdorf · DEUniversity of Manchester · GBUniversity of Tübingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe TORRACTO

methodsThe effects of once-daily tiotropium/olodaterol (2.5/5 and 5/5 μg) on endurance time during constant work-rate cycle ergometry (CWRCE) after 6 and 12 weeks of treatment were compared with placebo in patients with COPD in a randomized, double-blind, placebo-controlled, parallel-group clinical trial. Endurance time during the endurance shuttle walk test (ESWT) after 6 and 12 weeks of treatment was also evaluated in a subset of patients.

resultsA total of 404 patients received treatment, with 165 participating in the ESWT substudy. A statistically significant improvement in endurance time during CWRCE was observed after 12 weeks (primary endpoint) with tiotropium/olodaterol 5/5 µg [14% ( p = 0.02)] but not with tiotropium/olodaterol 2.5/5 µg [9% ( p = 0.14)] versus placebo. In the ESWT substudy, a trend to improvement in endurance time during ESWT after 12 weeks (key secondary endpoint) was observed with tiotropium/olodaterol 5/5 µg [21% ( p = 0.055)] and tiotropium/olodaterol 2.5/5 µg [21% ( p = 0.056)] versus placebo.

conclusionTiotropium/olodaterol 5/5 µg improved endurance time during cycle ergometry versus placebo, with a strong tendency to also improve walking endurance time. [ ClinicalTrials.gov identifier: NCT01525615.].

Indexed as

BicyclingWalkingAdministration, InhalationAdrenergic beta-2 Receptor AgonistsAdultAgedBenzoxazinesBronchodilator AgentsCholinergic AntagonistsDouble-Blind MethodDrug Administration ScheduleDrug CombinationsExercise ToleranceFemaleForced Expiratory VolumeHumansAdrenergic beta-2 Receptor AgonistsBenzoxazinesBronchodilator AgentsCholinergic AntagonistsDrug CombinationsTiotropium Bromidetiotropium-olodaterolbronchodilatorconstant work-rate cyclingCOPDendurance shuttle walkingolodateroltiotropium

Identifiers

PMID29439648
PMCPMC5937154
OpenAlexW2794058912

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.