Randomized Trial of Once-Daily Fluticasone Furoate in Children with Inadequately Controlled Asthma.
OBJECTIVE
To evaluate the dose-response, efficacy, and safety of fluticasone furoate (FF; 25 µg, 50 µg, and 100 µg), administered once daily in the evening during a 12-week treatment period to children with inadequately controlled asthma.


METHODS
This was a Phase IIb, multicenter, stratified, randomized, double-blind, double-dummy, parallel-group, placebo- and active-controlled study in children aged 5-11 years with inadequately controlled asthma. The study comprised a 4-week run-in period, 12-week treatment period, and 1-week follow-up period. Children were randomized to receive either placebo once daily, fluticasone propionate (FP) 100 µg twice daily, FF 25 µg, FF 50 µg, or FF 100 µg each once daily in the evening. Primary endpoint was the mean change from baseline in daily morning peak expiratory flow (PEF) averaged over weeks 1-12. Adverse events (AEs) also were investigated.


RESULTS
In total, 593 children were included in the intent-to-treat population. The difference vs placebo in change from baseline daily morning PEF averaged over weeks 1-12 was statistically significant for the FF 25, FF 50, FF 100, and FP 100 groups (18.6 L/min, 19.5 L/min, 12.5 L/min, and 14.0 L/min, respectively; P < .001 for all). The incidence of AEs was greater in the FF groups (32%-36%) than in the placebo group (29%); the most frequent AE was cough.


CONCLUSIONS
FF and FP resulted in significant improvements in morning PEF compared with placebo, suggesting that they are effective treatments for children with inadequately controlled asthma. All treatments were well tolerated; no new safety concerns were identified.


BACKGROUND
ClinicalTrials.gov:NCT01563029.
Respiratory Therapy Area, GlaxoSmithKline, Uxbridge, UK. Electronic address: amanda.j.oliver@gsk.com.
Amanda J
AJ
Oliver
Department of Pediatrics, National Jewish Health, Denver, CO.
Ronina A
RA
Covar
Respiratory Therapy Area, GlaxoSmithKline, Uxbridge, UK.
Caroline H
CH
Goldfrad
Southern California Clinical Trials, Newport Beach, CA.
Ryan M
RM
Klein
Pediatric Research Unit, Kolding Hospital, University of Southern Denmark, Kolding, Denmark.
Søren E
SE
Pedersen
Departments of Pharmacy Practice and Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI.
Christine A
CA
Sorkness
Respiratory Therapy Area, GlaxoSmithKline, Uxbridge, UK.
Susan A
SA
Tomkins
Clinica Ricardo Palma, San Isidro, Lima, Peru.
César
C
Villarán
Blizard Institute, Queen Mary University London, London, UK.
Jonathan
J
Grigg
D000280:Administration, Inhalation; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D016896:Treatment Outcome
D000730:Androstadienes; D001993:Bronchodilator Agents; C523187:fluticasone furoate
asthma; fluticasone furoate; inhaled corticosteroids; spirometry