![]() ![]() This was followed by a 3-week washout, after which the treatments were switched for a second 8-week treatment period (Fig. A full list of the medications permitted during the study is presented in Table S1.Īfter a 2-week run-in period, eligible patients were randomized (with use of the RAMOS automated randomization system) to receive either open-label UMEC/VI (62.5/25 µg) administered once daily via the ELLIPTA inhaler (via one puff) or open-label TIO/OLO (5/5 µg) administered once daily via the Respimat inhaler (via two puffs of 2.5/2.5 µg) for 8 weeks. As-needed use of supplemental albuterol was permitted throughout the study to provide additional symptomatic relief (though not in the 4 h before spirometry testing). This included LAMAs, LABAs, oral β-agonists, theophyllines, ICS, and phosphodiesterase 4 inhibitors. Maintenance medications for COPD (other than the study medication) were not permitted during any period of the study. Full inclusion and exclusion criteria are presented in the electronic supplementary material. Key exclusion criteria were as follows: the presence of any major respiratory disease other than COPD the use of inhaled corticosteroid (ICS) treatment in the 30 days before screening and a moderate/severe exacerbation or lower respiratory tract infection during the run-in period. Key eligibility criteria for enrollment in the study were as follows: an outpatient aged 40 years or older with a diagnosis of COPD in accordance with the American Thoracic Society/European Respiratory Society definition a current or former smoker with a smoking history of 10 pack-years or more a prebronchodilator and postbronchodilator FEV 1/forced vital capacity (FVC) ratio less than 0.70 a postbronchodilator FEV 1 of 70% or less and 50% or more of predicted normal values at visit 1 and a score of 2 or more on the modified Medical Research Council Dyspnoea Scale at visit 1. ![]() The safety of both treatments was also assessed. The primary objective of this 8-week study was to evaluate the magnitude of lung function improvements in patients receiving UMEC/VI or TIO/OLO who had sufficient COPD symptoms to justify the use of dual bronchodilator therapy. These combination therapies are the only LAMA/LABA combinations approved in both the USA and Europe as once-daily maintenance therapies for COPD. This study is the first direct comparison of the two once-daily fixed-dose LAMA/LABA combinations UMEC/vilanterol (VI), 62.5/25 µg, delivered via a multidose dry powder inhaler (ELLIPTA, a registered trademark of the GlaxoSmithKline group of companies), and TIO/olodaterol (OLO), 5/5 µg, delivered via a soft mist inhaler (Respimat, a registered trademark of Boehringer Ingelheim). Because of the limitations of indirect treatment comparisons, however, data from direct head-to-head comparisons are required to confirm these findings. Indirect evidence from network meta-analyses suggests a potential gradient of effectiveness may exist, at least with regard to lung function. As such, it remains unclear whether the efficacy differences between once-daily UMEC and TIO monotherapies would still be present when they are administered as a component of a dual LAMA/LABA bronchodilator therapy. To date, no direct comparative trials have examined the efficacy and safety differences between the once-daily LAMA/LABA combinations. Multiple randomized controlled trials have demonstrated greater improvements in lung function and patient-reported outcomes, including exacerbations, with LAMA/LABA combinations compared with LAMA or LABA monotherapies in patients with stable COPD. The efficacy of the LAMA umeclidinium (UMEC), 62.5 µg, was recently shown to be superior to that of the widely used tiotropium (TIO), 18 µg, with a significant increase in trough forced expiratory volume in 1 s (FEV 1) after 12 weeks of monotherapy. īronchodilator therapy has been shown to improve lung function, decrease the severity of symptoms, and reduce the risk of future exacerbations in COPD. The cornerstone of pharmacological therapy for COPD is bronchodilation, with a long-acting muscarinic antagonist (LAMA), a long-acting β 2-agonist (LABA), or a combination of the two. Chronic obstructive pulmonary disease (COPD) is one of the leading global causes of death and morbidity, and presents a considerable economic burden to healthcare systems worldwide.
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