PURPOSE OF THIS STUDY.
To assess the efficacy, dose response, and safety of inhaled corticosteroid, fluticasone furoate (FF), in children with inadequately controlled asthma.
This was a multicenter, multicountry study with the following inclusion criteria: children between ages 5 to 11 years who had asthma symptoms at least 6 months before the study screening and who at the intake were on short-acting β-agonist (SABA) alone, SABA with leukotriene modifying agent, or SABA with low-dose inhaled corticosteroid for >4 weeks before the screening.
The design is a phase IIb, multiple center, randomized, double-blind, placebo- and active-controlled study. The study assessed a 4-week pretreatment period, 12-week treatment period, and a 1-week follow-up period. The children were randomly placed in 1 of 5 groups including placebo, fluticasone propionate (FP) 100 mcg, FF at 25 mcg, 50 mcg, and 100 mcg. The primary endpoint was assessed by the mean change from baseline in daily morning peak expiratory flow (PEF) over the 12 weeks. Secondary endpoints such as rescue-free days were assessed to further expand on the clinical impact of the treatment. Pharmacokinetic and safety endpoints were also measured.
One thousand five-hundred forty children were initially assessed for eligibility for which 881 children were placed in the 4-week pretreatment period. Of those patients, 593 children entered the study and were randomly assigned to 1 of the 5 treatment groups. There was a statistically significant change from baseline daily morning PEF average over the 12 weeks in each FF dose group by an increase of 18.6 L/min (FF 25mcg), 19.5 L/min (FF 50 mcg), and 12.5 L/min (FF mcg 100); the P value was < .001 on all dose groups. The only significant PEF average increase above baseline in the FP group was for the 100 mcg (14.0 L/min with P < .001) dose. Importantly, there were statistically significant percent increases of rescue-free days in the FF 50 mcg and FF 100 mcg (9.8%, P = .023 and 12.2%, P = .004, respectively) which meant 0.7 and 0.9 rescue-free days per week. Adverse events (AEs) in FF treatment groups (32%–36%) were greater than in the placebo group (29%); the most frequent AE being cough.
The study suggested that both FP and FF had significant improvements compared with placebo in terms of asthma control. Although AEs were slightly increased over placebo, FP and FF were generally well-tolerated; therefore, both formulations are reasonable options for patients with uncontrolled asthma.
FP is a common medication started for initial asthma maintenance therapy shown to improve patients’ symptoms and PEF measurements. The study also suggests that a less commonly used medication, FF, has comparable efficacy with no new concerning adverse effects. This study shows there is a comparable alternative choice for providers to recommend on initiation of treatment as well as escalation of therapy for uncontrolled asthma.
- Copyright © 2017 by the American Academy of Pediatrics