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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 trough FEV1 up to day 169 (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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f2-copd-10-1753: LS mean change from baseline in trough FEV1 up to day 169 (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: Both UMEC/VI 125/25 μg and UMEC/VI 62.5/25 μg demonstrated a statistically significantly greater change from baseline in trough FEV1 at day 169 compared with 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) (Table 2). The treatment differences relative to placebo were also statistically significant versus placebo at all other time points assessed (Figure 2). On day 1, statistically significantly greater changes from baseline in 0-to 6-hour WM FEV1 were observed for both the UMEC/VI 125/25 μg and UMEC/VI 62.5/25 μg treatment groups compared with 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) (Table 2).


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 trough FEV1 up to day 169 (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

f2-copd-10-1753: LS mean change from baseline in trough FEV1 up to day 169 (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: Both UMEC/VI 125/25 μg and UMEC/VI 62.5/25 μg demonstrated a statistically significantly greater change from baseline in trough FEV1 at day 169 compared with 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) (Table 2). The treatment differences relative to placebo were also statistically significant versus placebo at all other time points assessed (Figure 2). On day 1, statistically significantly greater changes from baseline in 0-to 6-hour WM FEV1 were observed for both the UMEC/VI 125/25 μg and UMEC/VI 62.5/25 μg treatment groups compared with 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) (Table 2).

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