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      Dual bronchodilation with tiotropium/olodaterol further reduces activity-related breathlessness versus tiotropium alone in COPD

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          Abstract

          The 3-min constant speed shuttle test (CSST) was used to examine the effect of tiotropium/olodaterol compared with tiotropium at reducing activity-related breathlessness in patients with chronic obstructive pulmonary disease (COPD).

          This was a randomised, double-blind, two-period crossover study including COPD patients with moderate to severe pulmonary impairment, lung hyperinflation at rest and a Mahler Baseline Dyspnoea Index <8. Patients received 6 weeks of tiotropium/olodaterol 5/5 µg and tiotropium 5 µg in a randomised order with a 3-week washout period. The speed for the 3-min CSST was determined for each patient such that an intensity of breathing discomfort ≥4 (“somewhat severe”) on the modified Borg scale was reached at the end of a completed 3-min CSST.

          After 6 weeks, there was a decrease in the intensity of breathlessness (Borg dyspnoea score) at the end of the 3-min CSST from baseline with both tiotropium (mean –0.968, 95% CI −1.238– −0.698; n=100) and tiotropium/olodaterol (mean −1.325, 95% CI −1.594– −1.056; n=101). The decrease in breathlessness was statistically significantly greater with tiotropium/olodaterol versus tiotropium (treatment difference −0.357, 95% CI −0.661– −0.053; p=0.0217).

          Tiotropium/olodaterol reduced activity-related breathlessness more than tiotropium in dyspnoeic patients with moderate to severe COPD exhibiting lung hyperinflation.

          Abstract

          Tiotropium/olodaterol reduces activity-related breathlessness versus tiotropium in COPD http://ow.ly/MVyk30niV1o

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          Most cited references19

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          Development of a shuttle walking test of disability in patients with chronic airways obstruction.

          The aim was to develop a standardised and externally paced field walking test, incorporating an incremental and progressive structure, to assess functional capacity in patients with chronic airways obstruction. The usefulness of two different shuttle walking test protocols was examined in two separate groups of patients. The initial 10 level protocol (group A, n = 10) and a subsequent, modified, 12 level protocol (group B, n = 10) differed in the number of increments and in the speeds of walking. Patients performed three shuttle walking tests one week apart. Then the performance of patients (group C, n = 15) in the six minute walking test was compared with that in the second (modified) shuttle walking test protocol. Heart rate was recorded during all the exercise tests with a short range telemetry device. The 12 level modified protocol provided a measure of functional capacity in patients with a wide range of disability and was reproducible after just one practice walk; the mean difference between trial 2 v 3 was -2.0 (95% CI -21.9 to 17.9) m. There was a significant relation between the distance walked in the six minute walking test and the shuttle walking test (rho = 0.68) but the six minute walking test appeared to overestimate the extent of disability in some patients. The shuttle test provoked a graded cardiovascular response not evident in the six minute test. Moreover, the maximal heart rates attained were significantly higher for the shuttle walking test than for the six minute test. The shuttle walking test constitutes a standardised incremental field walking test that provokes a symptom limited maximal performance. It provides an objective measurement of disability and allows direct comparison of patients' performance.
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            Minimally clinically important difference for the UCSD Shortness of Breath Questionnaire, Borg Scale, and Visual Analog Scale.

            L Ries (2005)
            Dyspnea is a primary symptom of chronic lung disease and an important outcome measure for clinical trials. Several standardized measures have been developed to evaluate this important symptom and are being used increasingly in clinical trials. The minimally clinically important difference (MCID) is not well defined for these measures but is important in interpreting the clinical meaning of results of studies in this area. The purpose of this paper is to evaluate the MCID for three commonly used measures to assess dyspnea in chronic lung disease: UCSD Shortness of Breath Questionnaire (SOBQ), Borg Scale (Borg), and Visual Analog Scale (VAS). The analysis is based on a retrospective review of published trials evaluating the response to a pulmonary rehabilitation or exercise intervention that is known to produce modest, but clinically meaningful changes for such patients. Using a distribution-based approach based primarily on effect size, the recommended MCID for these measures are: 5-units for the SOBQ, 1-unit for the Borg scale, and approximately 10 to 20 units for the VAS.
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              Tiotropium + olodaterol shows clinically meaningful improvements in quality of life.

              Tiotropium + olodaterol improves lung function and symptoms compared to monotherapies in chronic obstructive pulmonary disease (COPD). The OTEMTO 1 and 2 studies investigated the effects of tiotropium + olodaterol on lung function and health-related quality of life compared to placebo in patients with moderate to severe COPD.
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                Author and article information

                Journal
                Eur Respir J
                Eur. Respir. J
                ERJ
                erj
                The European Respiratory Journal
                European Respiratory Society
                0903-1936
                1399-3003
                March 2019
                28 March 2019
                : 53
                : 3
                : 1802049
                Affiliations
                [1 ]Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec, QC, Canada
                [2 ]Longartsenpraktijk, Hasselt, Belgium
                [3 ]Pulmonary Research Institute, LungenClinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany
                [4 ]Boehringer Ingelheim Canada, Burlington, ON, Canada
                [5 ]Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA
                [6 ]Queen's University and Kingston General Hospital, Kingston, ON, Canada
                Author notes
                François Maltais, Centre de Recherche, Institut Universitaire de Cardiologie et de Pneumologie de Québec, 2725 Chemin Sainte-Foy, Québec, QC G1V 4G5, Canada. E-mail: Francois.Maltais@ 123456fmed.ulaval.ca
                Article
                ERJ-02049-2018
                10.1183/13993003.02049-2018
                6437647
                30655277
                325dcc3b-ba46-44b8-b6d1-cc58be312c17
                Copyright ©ERS 2019

                This version is distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0.

                History
                : 14 August 2018
                : 23 December 2018
                Funding
                Funded by: Boehringer Ingelheim http://doi.org/10.13039/100001003
                Categories
                Original Articles
                COPD
                1

                Respiratory medicine
                Respiratory medicine

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