Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma

Respiratory Research

Eric D Bateman¹  Brett Haumann⁶  Loretta Jacques⁶  Lucy Frith⁶  Neil G Snowise⁶  Jan Lötvall³  William W Busse²  Eugene R Bleecker⁴  Ashley Woodcock⁵ 

[1] Department of Medicine, University of Cape Town, Cape Town, South Africa;Department of Medicine, University of Wisconsin, Madison, USA;Krefting Research Centre, University of Gothenburg, Gothenburg, Sweden;Center for Genomics and Personalized Medicine, Wake Forest University Health Sciences, Winston-Salem, NC, USA;School of Translational Medicine, University of Manchester, Manchester, UK;Respiratory Medicines Development Centre, GlaxoSmithKline, Uxbridge, UK

关键词: safety;    efficacy;    once daily;    inhaled corticosteroid;    fluticasone furoate;    Asthma;   

Others  :  796762
DOI  :  10.1186/1465-9921-12-160

 received in 2011-07-19, accepted in 2011-12-21,  发布年份 2011

【 摘 要 】

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 ≥ 12 years; pre-bronchodilator forced expiratory volume in 1 second (FEV₁) 40-85% predicted; FEV₁ reversibility of ≥ 12% and ≥ 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 ≥ 8 weeks prior to enrolment and subsequently received doses of FF or FP 200 μg OD, FF or FP 100 μg 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 μg OD and FF 100 μg 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 μg OD to be non-inferior (pre-defined limit -110 ml) to FF 100 μg BD (mean treatment difference 11 ml; 95% CI: -35 to +56 ml); all FF and FP regimens were significantly superior to placebo (p ≤ 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 μg OD, 0.75; 100 μg BD, 0.84; p ≤ 0.02).

Conclusions

FF 200 μg 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.

【 授权许可】

   
2011 Woodcock et al; licensee BioMed Central Ltd.

【 图 表 】

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