Once daily fluticasone furoate, used at a dose of 100 µg or 200 µg, provides substantial improvements in lung function and asthma control for patients with uncontrolled moderate-to-severe asthma, phase III trial results show.
“Numerically greater benefit on baseline trough FEV1 [forced expiratory volume in 1 second] was observed in patients receiving [fluticasone furoate] 200 µg compared with the lower dose, though this descriptive study did not incorporate testing for statistical significance”, Ashley Woodcock (University of Manchester, UK) and co-researchers remark.
The 24-week, double-blind, multicentre, parallel-group study included 238 patients aged 12 years or older (mean age, 45.9 years) with moderate-to-severe persistent asthma that was uncontrolled on mid- to high-dose inhaled corticosteroids (ICS). The patients were randomly assigned to receive fluticasone furoate 100 µg or 200 µg once daily via dry powder inhaler.
As reported in BMC Pulmonary Medicine, both doses were associated with improvements in mean trough FEV1 from baseline to week 24, but the increase was greater in the 200 µg group (284 mL) than in the 100 µg group (208 mL).
Larger improvements were seen among patients with a baseline FEV1 that was 65% or less than the predicted value. In these patients, FEV1 increased by 359 mL with fluticasone furoate 200 µg and by 305 mL with the 100 µg dose. The respective increases in patients with a baseline FEV1 above 65% predicted were 227 mL and 134 mL.
The researchers observed clinically meaningful improvements from baseline in asthma control test (ACT) score in both groups. Specifically, 59% and 53% of patients in the 200 µg and 100 µg groups, respectively, reported well-controlled asthma (ACT score ≥20) after 24 weeks of treatment, increasing from 14% at baseline in both groups.
The percentage of rescue-free and symptom-free 24-hour periods also improved, to a similar degree, in both groups over the 24-week study period. The improvements equated to an additional 1.5 to 1.6 rescue-free days and 1.2 to 1.4 symptom-free days per week .
Woodcock and co-authors note that the overall safety profile of both doses of fluticasone furoate was similar to that seen in previous studies with treatment-related adverse events (mainly oropharyngeal candidiasis) reported by six patients in the 200 µg group and one patient in the 100 µg group. There was no evidence of cortisol suppression.
The researchers say that their findings “should be interpreted in light of the ongoing debate about the therapeutic options for patients whose asthma is uncontrolled on medium-dose ICS.”
They add that although the addition of a long-acting beta agonist to ongoing ICS therapy in patients uncontrolled on medium-dose ICS is generally recommended, “an increase in ICS dose may be more appropriate” in some patients.
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