Back to Search
Start Over
28-Day safety and tolerability of umeclidinium in combination with vilanterol in COPD: a randomized placebo-controlled trial.
- Source :
-
Pulmonary pharmacology & therapeutics [Pulm Pharmacol Ther] 2012 Dec; Vol. 25 (6), pp. 465-71. Date of Electronic Publication: 2012 Aug 31. - Publication Year :
- 2012
-
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.<br />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).<br />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.<br />Conclusion: Once-daily dosing with UMEC in combination with VI in patients with moderate-to-very-severe COPD was well tolerated over 28 days.<br /> (Copyright © 2012 Elsevier Ltd. All rights reserved.)
- Subjects :
- Administration, Inhalation
Adrenergic beta-2 Receptor Agonists administration & dosage
Adrenergic beta-2 Receptor Agonists adverse effects
Adrenergic beta-2 Receptor Agonists therapeutic use
Adult
Aged
Aged, 80 and over
Area Under Curve
Benzyl Alcohols administration & dosage
Benzyl Alcohols adverse effects
Chlorobenzenes administration & dosage
Chlorobenzenes adverse effects
Delayed-Action Preparations
Double-Blind Method
Drug Administration Schedule
Drug Combinations
Female
Follow-Up Studies
Forced Expiratory Volume
Humans
Male
Middle Aged
Muscarinic Antagonists administration & dosage
Muscarinic Antagonists adverse effects
Muscarinic Antagonists therapeutic use
Pulmonary Disease, Chronic Obstructive physiopathology
Quinuclidines administration & dosage
Quinuclidines adverse effects
Severity of Illness Index
Time Factors
Treatment Outcome
Benzyl Alcohols therapeutic use
Chlorobenzenes therapeutic use
Pulmonary Disease, Chronic Obstructive drug therapy
Quinuclidines therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1522-9629
- Volume :
- 25
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Pulmonary pharmacology & therapeutics
- Publication Type :
- Academic Journal
- Accession number :
- 22955035
- Full Text :
- https://doi.org/10.1016/j.pupt.2012.08.007