The efficacy of fluticasone furoate administered in the morning or evening is comparable in patients with persistent asthma.

Abstract

BACKGROUND:

The inhaled corticosteroid fluticasone furoate (FF) is efficacious as a once-daily treatment for the management of asthma. Asthma is associated with circadian changes, with worsening lung function at night. We compared the efficacy of once-daily FF in the morning or evening for the treatment of asthma.

METHODS:

Adults with persistent bronchial asthma were enrolled into this randomised, repeat-dose, double-blind, double-dummy, placebo-controlled, three-way crossover study. After a 14-day run-in period, patients received either: FF 100 μg in the morning (AM); FF 100 μg in the evening (PM); or placebo, via the ELLIPTA(®) dry powder inhaler. Patients received all three treatments (14 ± 2 day duration) separated by a 14- to 21-day washout period. The primary endpoint was 24-h weighted mean forced expiratory volume in 1 s (FEV1) measured at the end of each 14-day treatment.

RESULTS:

A total of 28 patients aged between 19 and 67 years were randomised and 21 (75%) completed all three study arms. Once-daily administration of FF 100 μg resulted in an increased 24-hour weighted mean FEV1; differences between the adjusted means for AM and PM FF dosing versus placebo were 0.077 L (90% confidence interval [CI]: 0.001, 0.152) and 0.105 L (90% CI: 0.029, 0.180), respectively (adjusted mean difference: -0.028 L [90% CI: -0.102, 0.045]). AM or PM doses had comparable incidences of adverse events (AEs; 18/23 versus 18/24, respectively), no serious AEs occurred.

CONCLUSION:

AM and PM doses of once-daily FF 100 μg produced comparable improvements in lung function relative to placebo.

• Authors: R D Kempsford, J Bal, A Baines, J Renaux, R Ravindranath, P S Thomas
• Journal: Respiratory medicine (Respir Med) Vol. 112 Pg. 18-24 (Mar 2016) ISSN: 1532-3064 [Electronic] England
• PMID: 26823210 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Chemical References

• Androstadienes
• Glucocorticoids
• fluticasone furoate

Topics

• Administration, Inhalation
• Adult
• Aged
• Androstadienes (administration & dosage)
• Asthma (drug therapy, physiopathology)
• Cross-Over Studies
• Double-Blind Method
• Drug Administration Schedule
• Female
• Forced Expiratory Volume
• Glucocorticoids (administration & dosage)
• Humans
• Male
• Middle Aged
• Treatment Outcome
• Young Adult