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      Efficacy and safety of the long-acting β 2-agonist olodaterol over 4 weeks in Japanese patients with chronic obstructive pulmonary disease

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          Abstract

          Background

          Olodaterol is a novel long-acting β 2-agonist with proven ≥24-hour duration of action in preclinical and clinical studies.

          Objective

          This randomized, double-blind, placebo-controlled, parallel-group study evaluated the dose response of once-daily (QD) olodaterol based on bronchodilator efficacy, safety, and pharmacokinetics over 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD).

          Methods

          All eligible patients were randomized to receive 2 µg, 5 µg, or 10 µg of olodaterol or placebo for 4 weeks via the Respimat ® Soft Mist™ inhaler. The primary end point was the change from baseline in trough forced expiratory volume in 1 second (FEV 1) after 4 weeks of olodaterol treatment. Secondary end points included trough FEV 1 after 1 week and 2 weeks of treatment, FEV 1 area under the curve from 0 hour to 3 hours (AUC 0–3), peak FEV 1 from 0 hour to 3 hours (peak FEV 1), and corresponding forced vital capacity (FVC) responses. Rescue medication use, COPD symptoms, physician global evaluation, pharmacokinetics, and safety were also assessed.

          Results

          A total of 328 patients with COPD were randomized to receive treatment. All olodaterol doses assessed in the study showed statistically significant increases in trough FEV 1 compared to placebo at Day 29 ( P<0.0001). Mean increases in peak FEV 1 and FEV 1 AUC 0–3 compared to placebo were also significant ( P<0.0001). A clear dose–response relationship was observed across all treatment groups. FVC responses (trough and FVC AUC 0–3) supported FEV 1 outcomes. All doses of olodaterol were well tolerated, and no safety concerns were identified.

          Conclusion

          QD olodaterol demonstrated 24-hour bronchodilator efficacy and was well tolerated in Japanese patients with COPD.

          Trial registration

          ClinicalTrials.gov: NCT00824382.

          Related collections

          Most cited references 17

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          Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop summary.

           ,  Suzanne Hurd,  P Calverley (2001)
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            A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease.

            Currently available inhaled bronchodilators used as therapy for chronic obstructive pulmonary disease (COPD) necessitate multiple daily dosing. The present study evaluates the long-term safety and efficacy of tiotropium, a new once-daily anticholinergic in COPD. Patients with stable COPD (age 65.2+/-8.7 yrs (mean+/-SD), n=921) were enrolled in two identical randomized double-blind placebo-controlled 1-yr studies. Patients inhaled tiotropium 18 microg or placebo (mean screening forced expiratory volume in one second (FEV1) 1.01 versus 0.99 L, 39.1 and 38.1% of the predicted value) once daily as a dry powder. The primary spirometric outcome was trough FEV1 (i.e. FEV1 prior to dosing). Changes in dyspnoea were measured using the Transition Dyspnea Index, and health status with the disease-specific St. George's Respiratory Questionnaire and the generic Short Form 36. Medication use and adverse events were recorded. Tiotropium provided significantly superior bronchodilation relative to placebo for trough FEV1 response (approximately 12% over baseline) (p<0.01) and mean response during the 3 h following dosing (approximately 22% over baseline) (p<0.001) over the 12-month period. Tiotropium recipients showed less dyspnoea (p<0.001), superior health status scores, and fewer COPD exacerbations and hospitalizations (p<0.05). Adverse events were comparable with placebo, except for dry mouth incidence (tiotropium 16.0% versus placebo 2.7%, p<0.05). Tiotropium is an effective, once-daily bronchodilator that reduces dyspnoea and chronic obstructive pulmonary disease exacerbation frequency and improves health status. This suggests that tiotropium will make an important contribution to chronic obstructive pulmonary disease therapy.
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              • Article: not found

              Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease

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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
                2015
                20 August 2015
                : 10
                : 1673-1683
                Affiliations
                [1 ]Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan
                [2 ]Nippon Boehringer Ingelheim Co. Ltd, Tokyo, Japan
                [3 ]Boehringer Ingelheim, Burlington, Ontario, Canada
                [4 ]Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany
                [5 ]Juntendo University School of Medicine, Tokyo, Japan
                Author notes
                Correspondence: Masakazu Ichinose, Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan, Tel +81 22 717 8534, Fax +81 22 717 8549, Email ichinose@ 123456rm.med.tohoku.ac.jp
                Article
                copd-10-1673
                10.2147/COPD.S86002
                4548739
                © 2015 Ichinose et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Categories
                Original Research

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