Efficacy and optimal dosing interval of the long-acting beta₂ agonist, vilanterol, in persistent asthma: a randomised trial.

Abstract

BACKGROUND:

Vilanterol (VI) is a novel once-daily long-acting beta₂ agonist with inherent 24-h activity. The aim of this study was to evaluate the efficacy of three once-daily doses and one twice-daily dose of VI used concurrently with ICS in adult patients (≥18 years) with persistent asthma. Safety was also assessed.

METHODS:

Multicentre, randomised, double-blind, placebo-controlled, five-period crossover study consisting of 7-day treatment periods separated by 7-day wash-out periods. Seventy-five patients, maintained on ICS, received VI 6.25, 12.5 and 25 mcg once-daily (evening), VI 6.25 mcg twice-daily (morning/evening), and placebo. The primary endpoint was trough forced expiratory volume in 1 s (FEV(1)) (mean of 23 h and 24 h post evening dose) on Day 7; secondary endpoint was weighted mean 24-h serial FEV(1) on Day 7.

RESULTS:

All VI groups demonstrated statistically significant increases in trough FEV(1) versus placebo (p < 0.001). There was a statistically significant increase in weighted mean 24-h FEV(1) for each VI group versus placebo (p < 0.001). The effects of once-daily VI on trough FEV(1) and weighted mean 24-h FEV(1) were dose dependent. The incidence of adverse events (AEs) was low in each VI treatment group and was not dose dependent (5-9%; placebo = 18%); no drug-related AEs or serious AEs were reported.

CONCLUSION:

Once-daily treatment with VI was well tolerated and associated with improvements in lung function. The VI 6.25 mcg twice-daily dose showed the greatest change in trough FEV(1), however, similar changes in weighted mean 24-h FEV(1) with VI 12.5 mcg once-daily were observed. Although our study was not powered to demonstrate non-inferiority of once- versus twice-daily dosing of VI, the data suggest no advantage over a 24-h period of twice-daily over once-daily dosing for the same total daily dose. ClinicalTrials.gov: NCT00980200.

• Authors: Richard Sterling, Jessica Lim, Lucy Frith, Neil G Snowise, Loretta Jacques, Brett Haumann
• Journal: Respiratory medicine (Respir Med) Vol. 106 Issue 8 Pg. 1110-5 (Aug 2012) ISSN: 1532-3064 [Electronic] England
• PMID: 22520084 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 Elsevier Ltd. All rights reserved.

Chemical References

• Adrenergic beta-2 Receptor Agonists
• Benzyl Alcohols
• Chlorobenzenes
• Glucocorticoids
• vilanterol

Topics

• Adrenergic beta-2 Receptor Agonists (administration & dosage, adverse effects, therapeutic use)
• Adult
• Asthma (drug therapy, physiopathology)
• Benzyl Alcohols (administration & dosage, adverse effects, therapeutic use)
• Chlorobenzenes (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Drug Administration Schedule
• Drug Therapy, Combination
• Female
• Forced Expiratory Volume (drug effects)
• Glucocorticoids (therapeutic use)
• Humans
• Male
• Middle Aged
• Treatment Outcome
• Young Adult