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      Randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of three doses of co-suspension delivery technology glycopyrronium MDI in Japanese patients with moderate-to-severe COPD

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          Abstract

          Purpose

          Due to the burden of COPD in Japan, new pharmacologic treatments are needed to meet patient requirements. This study assessed the efficacy and safety of glycopyrronium (GP) delivered via metered dose inhaler (MDI) in Japanese patients with moderate-to-severe COPD.

          Methods

          This Phase IIb, multicenter, randomized, double-blind, 7-day, crossover study compared GP MDI 28.8, 14.4, and 7.2 μg with placebo MDI (all administered as two inhalations, twice daily). The primary endpoint was change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV 1) on Day 8. Secondary endpoints included FEV 1 area under the curve from 0 to 2 hours (AUC 0–2) and peak change from baseline in FEV 1 on Days 1 and 8 and forced vital capacity AUC 0–2 on Day 8. Safety was also assessed. ClinicalTrials.gov Identifier: NCT03256552; http://www.ClinicalTrials.gov.

          Results

          Sixty-six patients were randomized and 62 were included in the modified intent-to-treat population (mean age 67.5 years). All three GP MDI doses significantly improved change from baseline in morning pre-dose trough FEV 1 on Day 8 compared with placebo MDI (least squares mean differences 108–131 mL; all p<0.0001). Significant improvements in secondary efficacy endpoints were also observed for all three GP MDI doses compared with placebo MDI (all p<0.0001). Dose–response plateaued at GP MDI 14.4 μg. No significant safety findings were observed with any GP MDI dose or placebo MDI.

          Conclusions

          The results of this study suggest that GP MDI 14.4 μg (7.2 μg per inhalation) is the most appropriate dose for use in Phase III studies in Japanese patients with moderate-to-severe COPD.

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          Most cited references 13

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          Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3.

          This updated Good Publication Practice (GPP) guideline, known as GPP3, builds on earlier versions and provides recommendations for individuals and organizations that contribute to the publication of research results sponsored or supported by pharmaceutical, medical device, diagnostics, and biotechnology companies. The recommendations are designed to help individuals and organizations maintain ethical and transparent publication practices and comply with legal and regulatory requirements. These recommendations cover publications in peer-reviewed journals and presentations (oral or poster) at scientific congresses. The International Society for Medical Publication Professionals invited more than 3000 professionals worldwide to apply for a position on the steering committee, or as a reviewer, for this guideline. The GPP2 authors reviewed all applications (n = 241) and assembled an 18-member steering committee that represented 7 countries and a diversity of publication professions and institutions. From the 174 selected reviewers, 94 sent comments on the second draft, which steering committee members incorporated after discussion and consensus. The resulting guideline includes new sections (Principles of Good Publication Practice for Company-Sponsored Medical Research, Data Sharing, Studies That Should Be Published, and Plagiarism), expands guidance on the International Committee of Medical Journal Editors' authorship criteria and common authorship issues, improves clarity on appropriate author payment and reimbursement, and expands information on the role of medical writers. By following good publication practices (including GPP3), individuals and organizations will show integrity; accountability; and responsibility for accurate, complete, and transparent reporting in their publications and presentations.
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            Experimental Designs Balanced for the Estimation of Residual Effects of Treatments

             EJ Williams (1949)
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              Global and regional trends in COPD mortality, 1990-2010.

              Between 1990 and 2010, chronic obstructive pulmonary disease (COPD) moved from the fourth to third most common cause of death worldwide. Using data from the Global Burden of Disease programme we quantified regional changes in the number of COPD deaths and COPD mortality rates between 1990 and 2010. We estimated the proportion of the change that was attributable to gross national income per capita and an index of cumulative smoking exposure, and quantified the difference in mortality rates attributable to demographic changes. Despite a substantial decrease in COPD mortality rates, COPD deaths fell only slightly, from three million in 1990 to 2.8 million in 2010, because the mean age of the population increased. The number of COPD deaths in 2010 would have risen to 5.2 million if the age- and sex-specific mortality rates had remained constant. Changes in smoking led to only a small increase in age- and sex-specific mortality rates, which were strongly associated with changes in gross national income. The increased burden of COPD mortality was mainly driven by changes in age distribution, but age- and sex-specific rates fell as incomes rose. The rapid response to increasing affluence suggests that changes in COPD mortality are not entirely explained by changes in early life.
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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
                13 April 2018
                : 13
                : 1187-1194
                Affiliations
                [1 ]Department of Internal Medicine, Fukuwa Clinic, Tokyo, Japan
                [2 ]Department of Internal Medicine, Nakatani Hospital, Hyogo, Japan
                [3 ]Department of Internal Medicine, Tokyo Center Clinic, Tokyo, Japan
                [4 ]Department of Internal Medicine, Sekino Hospital, Tokyo, Japan
                [5 ]Pearl – a member of the AstraZeneca Group, Morristown, NJ, USA
                [6 ]AstraZeneca, Gaithersburg, MD, USA
                Author notes
                Correspondence: Colin Reisner, Pearl – a member of the AstraZeneca Group, 280 Headquarters Plaza, East Tower, Morristown, NJ 07960, USA, Email colin.reisner@ 123456astrazeneca.com
                Article
                copd-13-1187
                10.2147/COPD.S159246
                5905841
                © 2018 Fukushima 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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