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A randomized, parallel-group study to evaluate the efficacy of umeclidinium/vilanterol 62.5/25 μg on health-related quality of life in patients with COPD.

Abstract

BACKGROUND

The combination of the inhaled muscarinic antagonist umeclidinium (UMEC) with the long-acting β2-agonist vilanterol (VI) has been shown to provide significant improvements in lung function compared with UMEC, VI, or placebo (PBO) in patients with chronic obstructive pulmonary disease (COPD). This study was specifically designed to support these findings by assessing health-related quality of life and symptomatic outcomes in a similar population.

METHODS

This was a 12-week multicenter, randomized, double-blind, parallel-group, placebo-controlled study. Eligible patients were randomized 1:1 to receive once-daily UMEC/VI 62.5/25 μg (via ELLIPTA(®) dry powder inhaler) or PBO for 12 weeks. The primary endpoint was St George's Respiratory Questionnaire (SGRQ) total score at day 84. Secondary efficacy endpoints included rescue albuterol use (puffs/day) over weeks 1-12 and trough forced expiratory volume in 1 second on day 84. Adverse events were also assessed.

RESULTS

A total of 496 patients were included in the intent-to-treat population in the UMEC/VI (n=248) and PBO (n=248) treatment groups. UMEC/VI 62.5/25 μg provided a significant and clinically meaningful improvement in SGRQ total score at day 84 versus PBO (difference between treatments in SGRQ total score change from baseline: -4.03 [95% confidence interval {CI}: -6.28, -1.79]; P<0.001). UMEC/VI 62.5/25 μg resulted in a statistically significant reduction in rescue albuterol use versus PBO (-0.7 puffs/day [95% CI: -1.1, -0.4]; P<0.001). UMEC/VI 62.5/25 μg provided a significant and clinically meaningful improvement in trough forced expiratory volume in 1 second on day 84 versus PBO (122 mL [95% CI: 71, 172]; P<0.001). The incidence of adverse events was similar between treatments (32% and 30% of patients in the UMEC/VI 62.5/25 μg and PBO groups, respectively).

CONCLUSION

The results of this study demonstrate that treatment with UMEC/VI 62.5/25 μg provides clinically important improvements in SGRQ and rescue medication use versus PBO in patients with moderate-to-very-severe COPD.

Authors+Show Affiliations

Midwest Chest Consultants, PC, St Charles, MO, USA.GSK, Research Triangle Park, NC, USA.GSK, Research Triangle Park, NC, USA; Pearl Therapeutics, Inc., Durham, NC, USA.GSK, Research Triangle Park, NC, USA.GSK, Respiratory Medicines Development Centre, Stockley Park, Middlesex, UK.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27274218

Citation

Siler, Thomas M., et al. "A Randomized, Parallel-group Study to Evaluate the Efficacy of Umeclidinium/vilanterol 62.5/25 Μg On Health-related Quality of Life in Patients With COPD." International Journal of Chronic Obstructive Pulmonary Disease, vol. 11, 2016, pp. 971-9.
Siler TM, Donald AC, O'Dell D, et al. A randomized, parallel-group study to evaluate the efficacy of umeclidinium/vilanterol 62.5/25 μg on health-related quality of life in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2016;11:971-9.
Siler, T. M., Donald, A. C., O'Dell, D., Church, A., & Fahy, W. A. (2016). A randomized, parallel-group study to evaluate the efficacy of umeclidinium/vilanterol 62.5/25 μg on health-related quality of life in patients with COPD. International Journal of Chronic Obstructive Pulmonary Disease, 11, pp. 971-9. doi:10.2147/COPD.S102962.
Siler TM, et al. A Randomized, Parallel-group Study to Evaluate the Efficacy of Umeclidinium/vilanterol 62.5/25 Μg On Health-related Quality of Life in Patients With COPD. Int J Chron Obstruct Pulmon Dis. 2016;11:971-9. PubMed PMID: 27274218.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, parallel-group study to evaluate the efficacy of umeclidinium/vilanterol 62.5/25 μg on health-related quality of life in patients with COPD. AU - Siler,Thomas M, AU - Donald,Alison C, AU - O'Dell,Dianne, AU - Church,Alison, AU - Fahy,William A, Y1 - 2016/05/09/ PY - 2016/6/9/entrez PY - 2016/6/9/pubmed PY - 2017/8/15/medline KW - COPD KW - SGRQ KW - health-related quality of life KW - long-acting bronchodilator KW - umeclidinium KW - vilanterol SP - 971 EP - 9 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 11 N2 - BACKGROUND: The combination of the inhaled muscarinic antagonist umeclidinium (UMEC) with the long-acting β2-agonist vilanterol (VI) has been shown to provide significant improvements in lung function compared with UMEC, VI, or placebo (PBO) in patients with chronic obstructive pulmonary disease (COPD). This study was specifically designed to support these findings by assessing health-related quality of life and symptomatic outcomes in a similar population. METHODS: This was a 12-week multicenter, randomized, double-blind, parallel-group, placebo-controlled study. Eligible patients were randomized 1:1 to receive once-daily UMEC/VI 62.5/25 μg (via ELLIPTA(®) dry powder inhaler) or PBO for 12 weeks. The primary endpoint was St George's Respiratory Questionnaire (SGRQ) total score at day 84. Secondary efficacy endpoints included rescue albuterol use (puffs/day) over weeks 1-12 and trough forced expiratory volume in 1 second on day 84. Adverse events were also assessed. RESULTS: A total of 496 patients were included in the intent-to-treat population in the UMEC/VI (n=248) and PBO (n=248) treatment groups. UMEC/VI 62.5/25 μg provided a significant and clinically meaningful improvement in SGRQ total score at day 84 versus PBO (difference between treatments in SGRQ total score change from baseline: -4.03 [95% confidence interval {CI}: -6.28, -1.79]; P<0.001). UMEC/VI 62.5/25 μg resulted in a statistically significant reduction in rescue albuterol use versus PBO (-0.7 puffs/day [95% CI: -1.1, -0.4]; P<0.001). UMEC/VI 62.5/25 μg provided a significant and clinically meaningful improvement in trough forced expiratory volume in 1 second on day 84 versus PBO (122 mL [95% CI: 71, 172]; P<0.001). The incidence of adverse events was similar between treatments (32% and 30% of patients in the UMEC/VI 62.5/25 μg and PBO groups, respectively). CONCLUSION: The results of this study demonstrate that treatment with UMEC/VI 62.5/25 μg provides clinically important improvements in SGRQ and rescue medication use versus PBO in patients with moderate-to-very-severe COPD. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/27274218/A_randomized_parallel_group_study_to_evaluate_the_efficacy_of_umeclidinium/vilanterol_62_5/25_μg_on_health_related_quality_of_life_in_patients_with_COPD_ L2 - https://dx.doi.org/10.2147/COPD.S102962 DB - PRIME DP - Unbound Medicine ER -