Source: Annual Congress 2010 - New treatments for asthma and COPD
Disease area: Airway diseases

Abstract

Introduction: FF is a novel ICS still active at 24 hours, in development as a once-daily (OD) treatment in combination with the LABA vilanterol trifenatate (GW642444M) for asthma and COPD.
Objectives: To evaluate the efficacy and safety of FF administered using a novel single-step activation dry powder inhaler in patients ≥12 years uncontrolled on moderate doses of ICS (fluticasone propionate [FP] 500mcg/day or equivalent). FP was used as an active control.
Methods: In this randomised, double-blind, placebo-controlled, double-dummy, parallel group study, 627 patients were randomised to FF (200, 400, 600 or 800mcg) OD, FP 500mcg twice daily or placebo for 8 weeks. Primary endpoint: change in trough (pre-dose) FEV₁ at Week 8.
Results: Primary: the test of linear trend in FF dose response relative to placebo for trough FEV₁ at Week 8 was significant (p≤0.001). However, no dose response between FF doses was observed. Secondary: PEF, symptom-free and rescue medication-free 24-hour periods, and withdrawals due to lack of efficacy supported the efficacy of FF 200–800mcg doses and FP. Incidence of oral candidiasis was highest for FF 800mcg (11%). 24-hour urinary cortisol excretion ratios (Week 8/baseline) for FF were similar to placebo except for FF 800mcg which was significantly lower.
Conclusion: This study supports the use of FF as a once-daily treatment for patients with asthma uncontrolled on moderate ICS doses.
Funded by GSK (FFA109684; NCT00603746)

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W. Busse, E. R. Bleecker, E. D. Bateman, J. Lötval, A. Woodcock, R. Forth, A. M. Davis, L. Jacques, B. Haumann (Madison, Winston-Salem, RTP, United States Of America; Cape Town, South Africa; Gothenburg, Sweden; Manchester, London, United Kingdom). Fluticasone furoate (FF), an inhaled corticosteroid (ICS), demonstrates efficacy in asthma patients symptomatic on moderate doses of ICS therapy. Eur Respir J 2010; 36: Suppl. 54, 1168

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