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      Indacaterol acetate/mometasone furoate provides sustained improvements in lung function compared with salmeterol xinafoate/fluticasone propionate in patients with moderate-to-very-severe COPD: results from a Phase II randomized, double-blind 12-week study

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          Abstract

          Background and purpose

          Fixed-dose combinations of a long-acting beta agonist and an inhaled corticosteroid are more effective than the individual components in COPD. The primary study objective was to demonstrate that the combination indacaterol acetate/mometasone furoate (IND/MF [QMF149]) was non-inferior to the twice-daily combination salmeterol xinafoate/fluticasone propionate (Sal/Flu) in terms of trough FEV 1 at week 12 (day 85). Secondary objectives were to compare the efficacy of IND/MF (QMF149) vs Sal/Flu with respect to other lung function parameters, COPD exacerbations, symptoms and dyspnea, health status/health-related quality of life, and rescue medication use.

          Materials and methods

          This was a 12-week multicenter, randomized, double-blind, double-dummy, parallel-group, Phase II study in patients with moderate-to-very-severe COPD, who were randomized (1:1) to IND/MF (QMF149) (150/160 µg once daily; n=316) or Sal/Flu (50/500 µg twice daily; n=313).

          Results

          Over 90% of patients completed the study: 94.6% in the IND/MF (QMF149) group and 92.0% in the Sal/Flu group. The primary objective of non-inferiority of IND/MF (QMF149) to Sal/Flu for trough FEV 1 at week 12 (day 85) was met: the lower limit of the CI (95% CI: 27.7, 83.3 mL) was greater than −60 mL. The analysis for superiority of IND/MF (QMF149) to Sal/Flu demonstrated superiority of IND/MF (QMF149), with a difference of 56 mL ( P<0.001). In addition, IND/MF (QMF149) treatment significantly improved COPD exacerbation-related parameters during the 12-week period. Other significant improvements with IND/MF (QMF 149) vs Sal/Flu were noted for dyspnea at week 12 and other COPD symptoms and COPD rescue medication use over the 12 weeks. The safety and tolerability profiles of both the treatments were similar.

          Conclusion

          IND/MF (QMF149) (150/160 µg once daily) offered superior lung function and symptom efficacy and a favorable safety profile compared with Sal/Flu (50/500 µg twice daily) in patients with moderate-to-very severe COPD.

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          Most cited references 25

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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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            The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes.

            To improve the clinical measurement of dyspnea, we developed a baseline dyspnea index that rated the severity of dyspnea at a single state and a transition dyspnea index that denoted changes from that baseline. The scores in both indexes depend on ratings for three different categories: functional impairment; magnitude of task, and magnitude of effort. At the baseline state, dyspnea was rated in five grades from 0 (severe) to 4 (unimpaired) for each category. The ratings for each of the three categories were added to form a baseline focal score (range, 0 to 12). At the transition period, changes in dyspnea were rated by seven grades, ranging from -3 (major deterioration), to +3 (major improvement). The ratings for each of the three categories were added to form a transition focal score (range, -9 to +9). In 38 patients tested with respiratory disease, interobserver agreement was highly satisfactory for both indexes. The baseline focal score had the highest correlation (r = 0.60; P less than 0.001) with the 12-minute walking distance (12 MW), while significant, but lower, correlations existed for lung function. For the transition focal score, there was a significant correlation only with the 12 MW (r = 0.33; p = 0.04). These results indicate that dyspnea can receive a direct clinical rating that provides important information not disclosed by customary physiologic tests.
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              Once-daily indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease (INVIGORATE): a randomised, blinded, parallel-group study.

              We compared the efficacy and safety of indacaterol and tiotropium in patients with severe chronic obstructive pulmonary disease (COPD) and a history of at least one moderate to severe exacerbation in the previous 12 months.
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                Author and article information

                Journal
                Int J Chron Obstruct Pulmon Dis
                Int J Chron Obstruct Pulmon Dis
                International Journal of COPD
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove Medical Press
                1176-9106
                1178-2005
                2018
                06 December 2018
                : 13
                : 3923-3936
                Affiliations
                [1 ]Insaf Respiratory Research Institute Wiesbaden, Wiesbaden, Germany, k.beeh@ 123456insaf-wi.de
                [2 ]Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany
                [3 ]Novartis Pharma AG, Basel, Switzerland
                [4 ]Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
                [5 ]IKF Pneumologie, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany
                [6 ]Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa
                Author notes
                Correspondence: Kai Michael Beeh, Insaf Respiratory Research Institute Wiesbaden, Biebricher Allee 34, D-65187 Wiesbaden, Germany, Tel +49 611 985 4347, Fax +49 611 985 4348, Email k.beeh@ 123456insaf-wi.de
                Article
                copd-13-3923
                10.2147/COPD.S179293
                6287650
                © 2018 Beeh et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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                Original Research

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