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28-Day safety and tolerability of umeclidinium in combination with vilanterol in COPD: a randomized placebo-controlled trial.
Pulm Pharmacol Ther. 2012 Dec; 25(6):465-71.PP

Abstract

BACKGROUND

Umeclidinium (UMEC; GSK573719) is a new long-acting muscarinic antagonist (LAMA) currently in development in combination with vilanterol (VI), an inhaled, long-acting beta₂ agonist for the treatment of chronic obstructive pulmonary disease (COPD). The primary aim of this study was to evaluate the safety and tolerability of repeat dosing of UMEC and VI in combination once daily for 28 days in patients with COPD.

METHODS

This was a multicenter, double-blind, placebo-controlled, parallel group study. Patients aged ≥40 years with post-bronchodilator FEV₁ ≤80% of predicted normal values and FEV₁/FVC ratio ≤0.70, and a smoking history of ≥10 pack-years, were randomized 4:1 to once-daily UMEC/VI (500/25 mcg; n = 42) or placebo (n = 9).

RESULTS

UMEC/VI was non-inferior to placebo in weighted mean pulse rate over 0-6 h at Day 28 (primary endpoint: difference of -0.5 bpm, 95% CI: -5.5 to 4.5). There was no evidence of a difference between UMEC/VI compared with placebo in blood pressure, minimum and maximum pulse rate, or QTcF assessments. Adverse events (AEs) were reported by 11 (26%) patients in the UMEC/VI group and one (11%) patient in the placebo group. No serious AEs were reported. Both UMEC and VI showed rapid absorption (median t(max) ∼6 min for both drugs) with no evidence of accumulation for AUC or C(max) on Day 28 compared with Day 1 for UMEC or VI. There was no correlation between individual steady-state C(max) and pulse rate on Day 28. Change from baseline in trough FEV₁ on Day 29 showed numerically greater improvements with UMEC/VI compared with placebo.

CONCLUSION

Once-daily dosing with UMEC in combination with VI in patients with moderate-to-very-severe COPD was well tolerated over 28 days.

Authors+Show Affiliations

S. Carolina Pharmaceutical Research, Spartanburg, SC, USA. gfeld3232@aol.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22955035

Citation

Feldman, Gregory, et al. "28-Day Safety and Tolerability of Umeclidinium in Combination With Vilanterol in COPD: a Randomized Placebo-controlled Trial." Pulmonary Pharmacology & Therapeutics, vol. 25, no. 6, 2012, pp. 465-71.
Feldman G, Walker RR, Brooks J, et al. 28-Day safety and tolerability of umeclidinium in combination with vilanterol in COPD: a randomized placebo-controlled trial. Pulm Pharmacol Ther. 2012;25(6):465-71.
Feldman, G., Walker, R. R., Brooks, J., Mehta, R., & Crater, G. (2012). 28-Day safety and tolerability of umeclidinium in combination with vilanterol in COPD: a randomized placebo-controlled trial. Pulmonary Pharmacology & Therapeutics, 25(6), 465-71. https://doi.org/10.1016/j.pupt.2012.08.007
Feldman G, et al. 28-Day Safety and Tolerability of Umeclidinium in Combination With Vilanterol in COPD: a Randomized Placebo-controlled Trial. Pulm Pharmacol Ther. 2012;25(6):465-71. PubMed PMID: 22955035.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 28-Day safety and tolerability of umeclidinium in combination with vilanterol in COPD: a randomized placebo-controlled trial. AU - Feldman,Gregory, AU - Walker,Robert R, AU - Brooks,Jean, AU - Mehta,Rashmi, AU - Crater,Glenn, Y1 - 2012/08/31/ PY - 2012/04/13/received PY - 2012/08/06/revised PY - 2012/08/21/accepted PY - 2012/9/8/entrez PY - 2012/9/8/pubmed PY - 2013/5/17/medline SP - 465 EP - 71 JF - Pulmonary pharmacology & therapeutics JO - Pulm Pharmacol Ther VL - 25 IS - 6 N2 - BACKGROUND: Umeclidinium (UMEC; GSK573719) is a new long-acting muscarinic antagonist (LAMA) currently in development in combination with vilanterol (VI), an inhaled, long-acting beta₂ agonist for the treatment of chronic obstructive pulmonary disease (COPD). The primary aim of this study was to evaluate the safety and tolerability of repeat dosing of UMEC and VI in combination once daily for 28 days in patients with COPD. METHODS: This was a multicenter, double-blind, placebo-controlled, parallel group study. Patients aged ≥40 years with post-bronchodilator FEV₁ ≤80% of predicted normal values and FEV₁/FVC ratio ≤0.70, and a smoking history of ≥10 pack-years, were randomized 4:1 to once-daily UMEC/VI (500/25 mcg; n = 42) or placebo (n = 9). RESULTS: UMEC/VI was non-inferior to placebo in weighted mean pulse rate over 0-6 h at Day 28 (primary endpoint: difference of -0.5 bpm, 95% CI: -5.5 to 4.5). There was no evidence of a difference between UMEC/VI compared with placebo in blood pressure, minimum and maximum pulse rate, or QTcF assessments. Adverse events (AEs) were reported by 11 (26%) patients in the UMEC/VI group and one (11%) patient in the placebo group. No serious AEs were reported. Both UMEC and VI showed rapid absorption (median t(max) ∼6 min for both drugs) with no evidence of accumulation for AUC or C(max) on Day 28 compared with Day 1 for UMEC or VI. There was no correlation between individual steady-state C(max) and pulse rate on Day 28. Change from baseline in trough FEV₁ on Day 29 showed numerically greater improvements with UMEC/VI compared with placebo. CONCLUSION: Once-daily dosing with UMEC in combination with VI in patients with moderate-to-very-severe COPD was well tolerated over 28 days. SN - 1522-9629 UR - https://www.unboundmedicine.com/medline/citation/22955035/28_Day_safety_and_tolerability_of_umeclidinium_in_combination_with_vilanterol_in_COPD:_a_randomized_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1094-5539(12)00124-1 DB - PRIME DP - Unbound Medicine ER -