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      Efficacy and safety of olodaterol once daily delivered via Respimat ® in patients with GOLD 2–4 COPD: results from two replicate 48-week studies

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          Abstract

          Background

          Olodaterol is a long-acting β 2-agonist with a 24-hour bronchodilator profile. Two replicate, randomized, double-blind, placebo-controlled, parallel-group, Phase III trials were performed as part of a comprehensive clinical program to investigate the long-term safety and efficacy of olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving usual-care background therapy.

          Methods

          Patients received olodaterol 5 μg or 10 μg or placebo once daily for 48 weeks. Coprimary end points were forced expiratory volume in 1 second (FEV 1) area under the curve from 0 to 3 hours (AUC 0–3) response (change from baseline), and trough FEV 1 response at 12 weeks. Secondary end points included additional lung function assessments, use of rescue medications, FEV 1 AUC response from 0 to 12 hours, and Patient Global Rating over 48 weeks.

          Results

          Overall, 624 and 642 patients were evaluated in studies 1222.11 and 1222.12, respectively. In both studies, olodaterol 5 μg and 10 μg significantly improved the FEV 1 AUC 0–3 response ( P<0.0001) and trough FEV 1 (study 1222.11, P<0.0001; study 1222.12, P<0.05, post hoc) at week 12, with an incidence of adverse events comparable with that of placebo. Secondary end points supported the efficacy of olodaterol.

          Conclusion

          These studies demonstrate the long-term efficacy and safety of once-daily olodaterol 5 μg and 10 μg in patients with moderate to very severe COPD continuing with usual-care maintenance therapy.

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          Most cited references 38

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          Assessing the minimal important difference in symptoms: a comparison of two techniques.

          We have developed a method for estimating the minimally important difference (MID) for health status measures. Whereas the conventional approach requires patients to judge themselves relative to their memories, our method requires patients to judge themselves relative to others with the same condition. In this study we examined whether our method (based on between-patient differences) and the conventional method (based on within-patient changes) provides comparable estimates of the MID for one health status measure: the Chronic Respiratory Questionnaire. Patients with chronic obstructive pulmonary disease who were participating in a supervised respiratory rehabilitation program were included if they were in stable health (n = 112). Their mean score per question in the Chronic Respiratory Questionnaire was 4.5 (range, 1 to 7; where bigger values indicate better health). Our method estimated that the MID was 0.5 (95% confidence interval 0.4 to 0.7). This estimate was similar to the MID previously found using the conventional method. These observations support the role of the Chronic Respiratory Questionnaire for measuring patient's symptoms, the validity of our approach for assessing the MID, and an estimate on the order of 0.5 as the threshold for this particular health status measure.
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            Combination bronchodilator therapy in the management of chronic obstructive pulmonary disease

            Chronic obstructive pulmonary disease (COPD) represents a significant cause of global morbidity and mortality, with a substantial economic impact. Recent changes in the Global initiative for chronic Obstructive Lung Disease (GOLD) guidance refined the classification of patients for treatment using a combination of spirometry, assessment of symptoms, and/or frequency of exacerbations. The aim of treatment remains to reduce existing symptoms while decreasing the risk of future adverse health events. Long-acting bronchodilators are the mainstay of therapy due to their proven efficacy. GOLD guidelines recommend combining long-acting bronchodilators with differing mechanisms of action if the control of COPD is insufficient with monotherapy, and recent years have seen growing interest in the additional benefits that combination of long-acting muscarinic antagonists (LAMAs), typified by tiotropium, with long-acting β2-agonists (LABAs), such as formoterol and salmeterol. Most studies have examined free combinations of currently available LAMAs and LABAs, broadly showing a benefit in terms of lung function and other patient-reported outcomes, although evidence is limited at present. Several once- or twice-daily fixed-dose LAMA/LABA combinations are under development, most involving newly developed monotherapy components. This review outlines the existing data for LAMA/LABA combinations in the treatment of COPD, summarizes the ongoing trials, and considers the evidence required to inform the role of LAMA/LABA combinations in treatment of this disease.
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              Bronchodilator responsiveness as a phenotypic characteristic of established chronic obstructive pulmonary disease.

              Bronchodilator responsiveness is a potential phenotypic characteristic of chronic obstructive pulmonary disease (COPD). We studied whether change in lung function after a bronchodilator is abnormal in COPD, whether stable responder subgroups can be identified, and whether these subgroups experience different clinical outcomes. 1831 patients with COPD, 285 smoking (SC) and 228 non-smoking (NSC) controls from the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) cohort. Spirometric reversibility to 400 μg inhaled salbutamol was assessed on four occasions over 1 year. Forced expiratory volume in 1 s (FEV(1)) increase after salbutamol was similar in SC (mean 0.14 litres (SD 0.15)) and COPD (0.12 litres (0.15)) and was significantly greater than NSC (0.08 litres (0.14)). Reversibility status varied with repeated testing in parallel with the day-to-day variation in pre-bronchodilator FEV(1), which was similar in control subjects and patients with COPD. Absolute FEV(1) change decreased by Global initiative for chronic Obstructive Lung Disease (GOLD) stage in patients with COPD (GOLD II, mean 0.16 litres (SD 0.17); III, 0.10 litres (0.13); IV, 0.05 litres (0.08) as did chances of being classified as reversible. CT-defined emphysema was weakly related to the absolute change in FEV(1) post salbutamol. Consistently reversible patients (n=227) did not differ in mortality, hospitalisation or exacerbation experience from irreversible patients when allowing for differences in baseline FEV(1). Reversibility only assessed with salbutamol and defined by FEV(1) criteria. The COPD population was older than the control populations. Post-salbutamol FEV(1) change is similar in patients with COPD and smoking controls but is influenced by baseline lung function and the presence of emphysema. Bronchodilator reversibility status varies temporally and does not distinguish clinically relevant outcomes, making it an unreliable phenotype.
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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
                2014
                16 June 2014
                : 9
                : 629-645
                Affiliations
                [1 ]Pulmonary Research Institute of Southeast Michigan, Livonia, MI, USA
                [2 ]S Carolina Pharmaceutical Research, Spartanburg, SC, USA
                [3 ]Pneumologie, Weinheim, Germany
                [4 ]Boehringer Ingelheim, Burlington, ON, Canada
                [5 ]Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA
                [6 ]Pulmonary Associates of Stamford, Stamford, CT, USA
                Author notes
                Correspondence: Gary T Ferguson, Pulmonary Research Institute of Southeast Michigan, 28815 Eight Mile Road, Suite 103, Livonia, MI 48152, USA, Tel +1 248 478 6561, Fax +1 248 478 6908, Email garytferguson@ 123456msn.com
                Article
                copd-9-629
                10.2147/COPD.S61717
                4064950
                © 2014 Ferguson 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

                Respiratory medicine

                chronic obstructive pulmonary disease, bronchodilator, olodaterol

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