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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.

Zheng J, Zhong N, Newlands A, Church A, Goh AH - Int J Chron Obstruct Pulmon Dis (2015)

Bottom Line: The incidence of adverse events was similar across groups.Symptomatic and quality of life measures also improved.The safety profile of UMEC/VI was consistent with previous studies.

View Article: PubMed Central - PubMed

Affiliation: 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.

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.

No MeSH data available.


Related in: MedlinePlus

LS mean change from baseline in serial FEV1 on day 1 (ITT population).Abbreviations: CI, confidence interval; FEV1, forced expiratory volume in 1 second; ITT, intent-to-treat; LS, least squares; UMEC, umeclidinium; VI, vilanterol.
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f3-copd-10-1753: LS mean change from baseline in serial FEV1 on day 1 (ITT population).Abbreviations: CI, confidence interval; FEV1, forced expiratory volume in 1 second; ITT, intent-to-treat; LS, least squares; UMEC, umeclidinium; VI, vilanterol.

Mentions: On day 1, serial FEV1 for both UMEC/VI 125/25 μg and UMEC/VI 62.5/25 μg demonstrated statistically significantly greater changes compared with placebo at 15 minutes post-dose (UMEC/VI 125/25 μg, 0.116 L, 95% CI 0.098–0.134; UMEC/VI 62.5/25 μg, 0.105 L, 95% CI 0.087–0.122; both P<0.001), which were sustained at each time point up to 24 hours postdose (Figure 3). Furthermore, patients had statistically significantly higher odds of achieving an increase in FEV1 of ≥12% and ≥0.200 L above baseline at day 1 compared with placebo (UMEC/VI 125/25 μg, odds ratio [OR] 27.8, 95% CI 13.7–56.6; UMEC/VI 62.5/25 μg, OR 20.5, 95% CI 10.1–41.6; both P<0.001) and also a statistically significantly higher OR of achieving an increase in trough FEV1 of ≥0.100 L above baseline at day 169 compared with placebo (UMEC/VI 125/25 μg, OR 6.1, 95% CI 3.8–9.7; UMEC/VI 62.5/25 μg, OR 5.3, 95% CI 3.4–8.4; both P<0.001).


Efficacy and safety of once-daily inhaled umeclidinium/vilanterol in Asian patients with COPD: results from a randomized, placebo-controlled study.

Zheng J, Zhong N, Newlands A, Church A, Goh AH - Int J Chron Obstruct Pulmon Dis (2015)

LS mean change from baseline in serial FEV1 on day 1 (ITT population).Abbreviations: CI, confidence interval; FEV1, forced expiratory volume in 1 second; ITT, intent-to-treat; LS, least squares; UMEC, umeclidinium; VI, vilanterol.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4562726&req=5

f3-copd-10-1753: LS mean change from baseline in serial FEV1 on day 1 (ITT population).Abbreviations: CI, confidence interval; FEV1, forced expiratory volume in 1 second; ITT, intent-to-treat; LS, least squares; UMEC, umeclidinium; VI, vilanterol.
Mentions: On day 1, serial FEV1 for both UMEC/VI 125/25 μg and UMEC/VI 62.5/25 μg demonstrated statistically significantly greater changes compared with placebo at 15 minutes post-dose (UMEC/VI 125/25 μg, 0.116 L, 95% CI 0.098–0.134; UMEC/VI 62.5/25 μg, 0.105 L, 95% CI 0.087–0.122; both P<0.001), which were sustained at each time point up to 24 hours postdose (Figure 3). Furthermore, patients had statistically significantly higher odds of achieving an increase in FEV1 of ≥12% and ≥0.200 L above baseline at day 1 compared with placebo (UMEC/VI 125/25 μg, odds ratio [OR] 27.8, 95% CI 13.7–56.6; UMEC/VI 62.5/25 μg, OR 20.5, 95% CI 10.1–41.6; both P<0.001) and also a statistically significantly higher OR of achieving an increase in trough FEV1 of ≥0.100 L above baseline at day 169 compared with placebo (UMEC/VI 125/25 μg, OR 6.1, 95% CI 3.8–9.7; UMEC/VI 62.5/25 μg, OR 5.3, 95% CI 3.4–8.4; both P<0.001).

Bottom Line: The incidence of adverse events was similar across groups.Symptomatic and quality of life measures also improved.The safety profile of UMEC/VI was consistent with previous studies.

View Article: PubMed Central - PubMed

Affiliation: 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.

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.

No MeSH data available.


Related in: MedlinePlus