Browsing by Author "Lotvall, Jan"

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    Efficacy in asthma of once-daily treatment with fluticasone furoate: a randomized, placebo-controlled trial
    (BioMed Central Ltd, 2011) Woodcock, Ashley; Bateman, Eric D; Busse, William W; Lotvall, Jan; Snowise, Neil G; Forth, Richard; Jacques, Loretta; Haumann, Brett; Bleecker, Eugene R
    BACKGROUND: Fluticasone furoate (FF) is a novel long-acting inhaled corticosteroid (ICS). This double-blind, placebo-controlled randomized study evaluated the efficacy and safety of FF 200 mcg or 400 mcg once daily, either in the morning or in the evening, and FF 200 mcg twice daily (morning and evening), for 8 weeks in patients with persistent asthma. METHODS: Asthma patients maintained on ICS for [greater than or equal to] 3 months with baseline morning forced expiratory volume in one second (FEV1) 50-80% of predicted normal value and FEV1 reversibility of [greater than or equal to] 12% and [greater than or equal to] 200 ml were eligible. The primary endpoint was mean change from baseline FEV1 at week 8 in pre-dose (morning or evening [depending on regimen], pre-rescue bronchodilator) FEV1. RESULTS: A total of 545 patients received one of five FF treatment groups and 101 patients received placebo (intent-to-treat population). Each of the five FF treatment groups produced a statistically significant improvement in pre-dose FEV1 compared with placebo (p < 0.05). FF 400 mcg once daily in the evening and FF 200 mcg twice daily produced similar placebo-adjusted improvements in evening pre-dose FEV1 at week 8 (240 ml vs. 235 ml). FF 400 mcg once daily in the morning, although effective, resulted in a smaller improvement in morning pre-dose FEV1 than FF 200 mcg twice daily at week 8 (315 ml vs. 202 ml). The incidence of oral candidiasis was low (0-4%) and UC excretion was comparable with placebo for all FF groups. CONCLUSIONS: FF at total daily doses of 200 mcg or 400 mcg was significantly more effective than placebo. FF 400 mcg once daily in the evening had similar efficacy to FF 200 mcg twice daily and all FF regimens had a safety tolerability profile generally similar to placebo. This indicates that inhaled FF is an effective and well tolerated once-daily treatment for mild-to-moderate asthma.TRIAL REGISTRATION:NCT00398645
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    Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma
    (BioMed Central Ltd, 2011) Woodcock, Ashley; Bleecker, Eugene R; Busse, William W; Lotvall, Jan; Snowise, Neil G; Frith, Lucy; Jacques, Loretta; Haumann, Brett; Bateman, Eric D
    BACKGROUND: Inhaled corticosteroids are the recommended first-line treatment for asthma but adherence to therapy is suboptimal. The objectives of this study were to compare the efficacy and safety of once-daily (OD) evening and twice-daily (BD) regimens of the novel inhaled corticosteroid fluticasone furoate (FF) in asthma patients. METHODS: Patients with moderate asthma (age [greater than or equal to] 12 years; pre-bronchodilator forced expiratory volume in 1 second (FEV1) 40-85% predicted; FEV1 reversibility of [greater than or equal to] 12% and [greater than or equal to] 200 ml) were randomized to FF or fluticasone propionate (FP) regimens in a double-blind, crossover study. Patients were not permitted to have used any ICS for [greater than or equal to] 8 weeks prior to enrolment and subsequently received doses of FF or FP 200 mug OD, FF or FP 100 mug BD and matching placebo by inhalation for 28 days each. Primary endpoint was Day 28 evening pre-dose (trough) FEV1; non-inferiority of FF 200 mug OD and FF 100 mug BD was assessed, as was superiority of all active treatment relative to placebo. Adverse events (AEs) and 24-hour urinary cortisol excretion were assessed. RESULTS: The intent-to-treat population comprised 147 (FF) and 43 (FP) patients. On Day 28, pre-dose FEV1 showed FF 200 mug OD to be non-inferior (pre-defined limit -110 ml) to FF 100 mug BD (mean treatment difference 11 ml; 95% CI: -35 to +56 ml); all FF and FP regimens were significantly superior to placebo (p [less than or equal to] 0.02). AEs were similar to placebo; no serious AEs were reported. Urinary cortisol excretion at Day 28 for FF was lower than placebo (ratios: 200 mug OD, 0.75; 100 mug BD, 0.84; p [less than or equal to] 0.02). CONCLUSIONS: FF 200 mug OD in the evening is an efficacious and well tolerated treatment for asthma patients and is not inferior to the same total BD dose.TRIAL REGISTRATION:Clinicaltrials.gov; NCT00766090.