Abstract
These studies evaluated the 24-h forced expiratory volume in 1 sec (FEV1) profile of once-daily (QD) olodaterol compared to placebo and twice-daily (BID) formoterol in patients with moderate to very severe chronic obstructive pulmonary disease. In two replicate, randomized, double-blind, double-dummy, four-way crossover studies, patients received olodaterol 5 and 10 μg QD, formoterol 12 μg BID, or placebo for 6 weeks in addition to usual-care background maintenance therapy. Co-primary end points were FEV1 area under the curve from 0–12 h (AUC0–12) response (change from baseline) and FEV1 AUC from 12–24 h (AUC12–24) response after 6 weeks, with FEV1 AUC from 0–24 h response identified as a key secondary end point. Other secondary end points included FEV1 AUC from 0–3 h and trough FEV1 responses, as well as corresponding forced vital capacity responses. With both olodaterol doses, FEV1 increased to near-maximal 30 min post-morning dose, which was sustained over 24 h. FEV1 also increased within 30 min post-morning dose of formoterol and was sustained over 12 h; the second formoterol dose resulted in a further increase, sustained for an additional 12 h. FEV1 AUC0–12 and AUC12–24 responses with both QD olodaterol doses and BID formoterol were significantly greater than placebo at 6 weeks (P < .0001). Secondary end-point outcomes were consistent with those of the co-primary end points. These data, together with those from the wider phase III clinical program, provide evidence for the 24-h bronchodilator efficacy of olodaterol QD in this patient population.Trial registryClinicalTrials.gov; NCT00931385 and NCT00932646.Electronic supplementary materialThe online version of this article (doi:10.1186/2193-1801-3-419) contains supplementary material, which is available to authorized users.
Highlights
Long-acting bronchodilators, such as long-acting β2agonists (LABAs) and long-acting muscarinic antagonists, are the cornerstone of pharmacologic therapy for patients with chronic obstructive pulmonary disease (COPD) and are considered central to symptom management (Global Initiative for Chronic Obstructive Lung Disease 2013)
Study outcomes The primary objective of the study was to determine if olodaterol 5 and 10 μg Once daily (QD) administered via the Respimat®
forced expiratory volume in 1 sec (FEV1) area under the curve from 0–12 h (AUC0–12) and AUC12–24 were chosen as co-primary end points to allow a comparison between the different dosing regimens of olodaterol QD and formoterol Twice daily (BID)
Summary
Long-acting bronchodilators, such as long-acting β2agonists (LABAs) and long-acting muscarinic antagonists, are the cornerstone of pharmacologic therapy for patients with chronic obstructive pulmonary disease (COPD) and are considered central to symptom management (Global Initiative for Chronic Obstructive Lung Disease 2013). Effective 24-h bronchodilation with olodaterol in both asthma and COPD has been confirmed by singledose studies (van Noord et al 2011; O’Byrne et al 2009) and studies over 4 weeks (Joos et al 2012; O’Byrne et al 2012; van Noord et al 2009). The results of these phase II studies provided the rationale to further investigate 5 and 10 μg QD doses of olodaterol in a phase III clinical program.
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