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Efficacy and safety of once-daily inhaled umeclidinium/vilanterol in Asian patients with COPD: results from a randomized, placebo-controlled study.
Int J Chron Obstruct Pulmon Dis. 2015; 10:1753-67.IJ

Abstract

BACKGROUND

Combination of the inhaled long-acting muscarinic antagonist umeclidinium (UMEC; GSK573719) with the long-acting β2-agonist vilanterol (VI) is an approved maintenance treatment for COPD in the US and EU. We compared the efficacy and safety of UMEC/VI with placebo in patients with COPD of Asian ancestry.

PATIENTS AND METHODS

In this 24-week, Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study, patients were randomized 1:1:1 to UMEC/VI 125/25 μg, UMEC/VI 62.5/25 μg, or placebo. The primary efficacy end point was trough forced expiratory volume in 1 second (FEV1) on day 169; secondary end points were Transition Dyspnea Index (TDI) focal score at week 24 and weighted mean (WM) FEV1 over 0-6 hours postdose on day 1. Additional end points and safety were also assessed.

RESULTS

Both UMEC/VI 125/25 μg and UMEC/VI 62.5/25 μg statistically significantly improved trough FEV1 at day 169 versus placebo (UMEC/VI 125/25 μg, 0.216 L, [95% confidence interval [CI] 0.175-0.257]; UMEC/VI 62.5/25 μg, 0.151 L, 95% CI 0.110-0.191; both P<0.001). Statistically significant improvements in TDI score were observed for both UMEC/VI groups versus placebo (UMEC/VI 125/25 μg, 0.9, 95% CI 0.3-1.4, P=0.002; UMEC/VI 62.5/25 μg, 0.7, 95% CI 0.1-1.2, P=0.016). On day 1, both UMEC/VI groups improved 0-6-hour WM FEV1 versus placebo (UMEC/VI 125/25 μg, 0.182 L 95% CI 0.161-0.203; UMEC/VI 62.5/25 μg, 0.160 L, 95% CI 0.139-0.181; both P<0.001). Statistically significant improvements for UMEC/VI groups versus placebo were observed for rescue albuterol use at weeks 1-24 (puffs/day, both P<0.001). The incidence of adverse events was similar across groups.

CONCLUSION

In Asian patients with COPD, once-daily UMEC/VI 125/25 μg and UMEC 62.5/25 μg resulted in clinically meaningful and statistically significant improvements in lung-function end points versus placebo. Symptomatic and quality of life measures also improved. The safety profile of UMEC/VI was consistent with previous studies.

Authors+Show Affiliations

State Key Lab of Respiratory Disease, National Clinical Research Centre of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People's Republic of China.State Key Lab of Respiratory Disease, National Clinical Research Centre of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People's Republic of China.GlaxoSmithKline, London, UK.GlaxoSmithKline, Research Triangle Park, NC, USA.GlaxoSmithKline, Shanghai, People's Republic of China.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

26366068

Citation

Zheng, Jinping, et al. "Efficacy and Safety of Once-daily Inhaled Umeclidinium/vilanterol in Asian Patients With COPD: Results From a Randomized, Placebo-controlled Study." International Journal of Chronic Obstructive Pulmonary Disease, vol. 10, 2015, pp. 1753-67.
Zheng J, Zhong N, Newlands A, et al. Efficacy and safety of once-daily inhaled umeclidinium/vilanterol in Asian patients with COPD: results from a randomized, placebo-controlled study. Int J Chron Obstruct Pulmon Dis. 2015;10:1753-67.
Zheng, J., Zhong, N., Newlands, A., Church, A., & Goh, A. H. (2015). Efficacy and safety of once-daily inhaled umeclidinium/vilanterol in Asian patients with COPD: results from a randomized, placebo-controlled study. International Journal of Chronic Obstructive Pulmonary Disease, 10, 1753-67. https://doi.org/10.2147/COPD.S81053
Zheng J, et al. Efficacy and Safety of Once-daily Inhaled Umeclidinium/vilanterol in Asian Patients With COPD: Results From a Randomized, Placebo-controlled Study. Int J Chron Obstruct Pulmon Dis. 2015;10:1753-67. PubMed PMID: 26366068.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of once-daily inhaled umeclidinium/vilanterol in Asian patients with COPD: results from a randomized, placebo-controlled study. AU - Zheng,Jinping, AU - Zhong,Nanshan, AU - Newlands,Amy, AU - Church,Alison, AU - Goh,Aik H, Y1 - 2015/09/02/ PY - 2015/9/15/entrez PY - 2015/9/15/pubmed PY - 2016/4/26/medline KW - Asian KW - chronic obstructive pulmonary disease KW - umeclidinium KW - vilanterol SP - 1753 EP - 67 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 10 N2 - BACKGROUND: Combination of the inhaled long-acting muscarinic antagonist umeclidinium (UMEC; GSK573719) with the long-acting β2-agonist vilanterol (VI) is an approved maintenance treatment for COPD in the US and EU. We compared the efficacy and safety of UMEC/VI with placebo in patients with COPD of Asian ancestry. PATIENTS AND METHODS: In this 24-week, Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study, patients were randomized 1:1:1 to UMEC/VI 125/25 μg, UMEC/VI 62.5/25 μg, or placebo. The primary efficacy end point was trough forced expiratory volume in 1 second (FEV1) on day 169; secondary end points were Transition Dyspnea Index (TDI) focal score at week 24 and weighted mean (WM) FEV1 over 0-6 hours postdose on day 1. Additional end points and safety were also assessed. RESULTS: Both UMEC/VI 125/25 μg and UMEC/VI 62.5/25 μg statistically significantly improved trough FEV1 at day 169 versus placebo (UMEC/VI 125/25 μg, 0.216 L, [95% confidence interval [CI] 0.175-0.257]; UMEC/VI 62.5/25 μg, 0.151 L, 95% CI 0.110-0.191; both P<0.001). Statistically significant improvements in TDI score were observed for both UMEC/VI groups versus placebo (UMEC/VI 125/25 μg, 0.9, 95% CI 0.3-1.4, P=0.002; UMEC/VI 62.5/25 μg, 0.7, 95% CI 0.1-1.2, P=0.016). On day 1, both UMEC/VI groups improved 0-6-hour WM FEV1 versus placebo (UMEC/VI 125/25 μg, 0.182 L 95% CI 0.161-0.203; UMEC/VI 62.5/25 μg, 0.160 L, 95% CI 0.139-0.181; both P<0.001). Statistically significant improvements for UMEC/VI groups versus placebo were observed for rescue albuterol use at weeks 1-24 (puffs/day, both P<0.001). The incidence of adverse events was similar across groups. CONCLUSION: In Asian patients with COPD, once-daily UMEC/VI 125/25 μg and UMEC 62.5/25 μg resulted in clinically meaningful and statistically significant improvements in lung-function end points versus placebo. Symptomatic and quality of life measures also improved. The safety profile of UMEC/VI was consistent with previous studies. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/26366068/Efficacy_and_safety_of_once_daily_inhaled_umeclidinium/vilanterol_in_Asian_patients_with_COPD:_results_from_a_randomized_placebo_controlled_study_ L2 - https://dx.doi.org/10.2147/COPD.S81053 DB - PRIME DP - Unbound Medicine ER -