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      A randomised, open-label study of umeclidinium versus glycopyrronium in patients with COPD

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          Abstract

          This study compared the efficacy and safety of once-daily umeclidinium 62.5 µg with once-daily glycopyrronium 50 µg in patients with moderate-to-severe chronic obstructive pulmonary disease.

          This was a 12-week, multicentre, randomised, open-label, parallel-group study ( Clinicaltrials.gov: NCT02236611). Patients were randomised 1:1 to umeclidinium 62.5 µg or glycopyrronium 50 µg administered via Ellipta or Breezhaler dry powder inhaler, respectively. The primary endpoint was trough forced expiratory volume in 1 s (FEV 1) at day 85 in the per-protocol population. Other endpoints included: weighted mean FEV 1 over 0–24 h and patient-reported outcomes (transition dyspnoea index score and St George's Respiratory Questionnaire total score). Adverse events were also assessed.

          A total of 1037 patients were randomised to treatment. Umeclidinium was non-inferior (margin: −50 mL) to glycopyrronium (trough FEV 1 at day 85 treatment difference: 24 mL, 95% confidence intervals: −5–54). Improvements in other endpoints were similar between treatments. Adverse event incidences were similar for umeclidinium (37%) and glycopyrronium (36%).

          Once-daily umeclidinium was non-inferior to once-daily glycopyrronium in patients with chronic obstructive pulmonary disease in trough FEV 1 at day 85. Patient-reported outcomes and safety profiles were similar for both treatments.

          Abstract

          Once-daily umeclidinium is non-inferior to once-daily glycopyrronium in patients with COPD by trough FEV 1 at day 85 http://ow.ly/4mRdE6

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          Most cited references19

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          Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper.

          W MacNee, , B Celli (2004)
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            St. George's Respiratory Questionnaire: MCID.

            The SGRQ is a disease-specific measure of health status for use in COPD. A number of methods have been used for estimating its minimum clinically important difference (MCID). These include both expert and patient preference-based estimates. Anchor-based methods have also been used. The calculated MCID from those studies was consistently around 4 units, regardless of assessment method. By contrast, the MCID calculated using distribution-based methods varied across studies and permitted no consistent estimate. All measurements of clinical significance contain sample and measurement error. They also require value judgements, if not about the calculation of the MCID itself then about the anchors used to estimate it. Under these circumstances, greater weight should be placed upon the overall body of evidence for an MCID, rather than one single method. For that reason, estimates of MCID should be used as indicative values. Methods of analysing clinical trial results should reflect this, and use appropriate statistical tests for comparison with the MCID. Treatments for COPD that produced an improvement in SGRQ of the order of 4 units in clinical trials have subsequently found wide acceptance once in clinical practice, so it seems reasonable to expect any new treatment proposed for COPD to produce an advantage over placebo that is not significantly inferior to a 4-unit difference.
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              Minimal clinically important differences in COPD lung function.

              The FEV1 is widely used by physicians in the diagnosis, staging, treatment, monitoring, and establishing prognosis for patients with COPD. The MCID is the smallest difference which patients perceive as beneficial and which would mandate a change in patient management. A precise MCID for FEV1 has not been established. In attempt to establish a MCID for predose or trough FEV1, several limitations need to be addressed. There are issues such as reproducibility, repeatability, acceptability, variability, placebo effect, and equipment effects. Patient factors, such as baseline level of FEV1, albuterol reversibility, diurnal variation, influence the results. Nonetheless, using anchoring techniques, a change in pre dose FEV1 of about 100 mL can be perceived by patients, correlates with fewer relapses following exacerbations and is in the range usually achieved with bronchodilators approved for COPD. In the future, consistent reporting of spirometric variables, such as a predose FEV1 and other outcomes, can be incorporated into a more quantitative effort to establish the MCID. Also distributional/statistical methods may be useful in determining the MCID FEV1.
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                Author and article information

                Journal
                ERJ Open Res
                ERJ Open Res
                ERJOR
                erjor
                ERJ Open Research
                European Respiratory Society
                2312-0541
                April 2016
                27 April 2016
                : 2
                : 2
                : 00101-2015
                Affiliations
                [1 ]GSK, Respiratory and Immuno-Inflammation, Research Triangle Park, NC, USA
                [2 ]GSK, Respiratory Research and Development, Middlesex, UK
                Author notes
                Tara Rheault, Quintiles, 5827 S. Miami Blvd, Morrisville, NC 27560, USA. E-mail: Tara.Rheault@ 123456quintiles.com
                Article
                00101-2015
                10.1183/23120541.00101-2015
                5005182
                27730198
                126f755a-b407-465c-9f87-7113a89f52bc
                Copyright ©ERS 2016

                This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0.

                History
                : 16 December 2015
                : 04 March 2016
                Funding
                Funded by: GlaxoSmithKline http://doi.org/10.13039/100004330
                Categories
                Original Articles

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