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

• Published in: Respiratory medicine Vol. 112; pp. 18 - 24
• Main Authors: Kempsford, R.D, Bal, J, Baines, A, Renaux, J, Ravindranath, R, Thomas, P.S
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01-03-2016; Elsevier Limited
• Subjects: Administration, Inhalation; Adult; Aged; Androstadienes - administration & dosage; Asthma; Asthma - drug therapy; Asthma - physiopathology; Confidence intervals; Cross-Over Studies; Double-Blind Method; Drug Administration Schedule; Efficacy; Evening dosing; Female; Fluticasone furoate; Forced Expiratory Volume; Glucocorticoids - administration & dosage; Humans; Inhaled corticosteroid; Male; Middle Aged; Morning dosing; Patients; Pulmonary/Respiratory; Statistical analysis; Treatment Outcome; Young Adult; FF; short-acting beta 2 agonist; FP; SD; Morning dosing; peak expiratory flow; Fluticasone furoate; serious adverse event; LABA; AE; CI; forced expiratory volume in 1 s; Inhaled corticosteroid; Efficacy; adverse event; SABA; AM; Asthma; morning; PEF; FEV 1; long-acting beta 2 agonist; URTI; SAE; Evening dosing; fluticasone propionate; ICS; confidence interval; evening; PM; upper respiratory tract infection; inhaled corticosteroids; standard deviation; FEV1
• ISSN: 0954-6111; 1532-3064
• DOI: 10.1016/j.rmed.2015.12.011

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.