Treatment options for asthma are limited for patients 4-11 years of age. Current guidelines recommend adding an inhaled long-acting beta2-agonist to an inhaled corticosteroid (ICS), as a preferred option versus increasing the ICS dose, thus ensuring the lowest effective dose of ICS is used. Hence, a clinical study was conducted to evaluate the safety of fluticasone propionate/salmeterol 100/50mcg (FSC) BID compared with fluticasone propionate (FP) 100mcg BID, both via Diskus®, in patients 4-11 years of age with asthma.
A 12-week, randomized, double-blind, parallel-group study was conducted in 40 patients 4 and 5 years of age, and 163 patients 6 to 11 years of age with asthma, who were symptomatic on an ICS.
No patient had an abnormal clinically significant ECG during treatment.
This study demonstrated that FSC 100/50mcg via Diskus twice daily has a favorable risk/benefit profile in patients 4-11 years of age with asthma and a similar safety profile to FP 100mcg Diskus twice daily.
FSC 100/50mcg via Diskus twice daily provides added clinical benefit in pediatric patients 4-11 years of age with asthma indicating that treatment of the two main components of asthma (inflammation and smooth muscle dysfunction) in children is more effective than treatment of a single component (i.e., inflammation) alone. (SAS30031). FSC 100/50mcg BIDFP 100mcg BID4 and 56 to 114 and 56 to 11n=21n=80n=19n=83Adverse events, n (%)15 (71)45 (56)15 (79)43 (52)# Pts with drug-related adverse events3927# Pts withdrawn due to an asthma exacerbation1132FEV1 (L) at Baselinen/a1.70n/a1.65FEV1 (L) at Endpointn/a1.88n/a1.77
P.M. Dorinsky, None.