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

Abstract

Introduction: FF is an ICS still active at 24 hours, in development as a once-daily (OD) treatment in combination with the long-acting beta₂ agonist, vilanterol trifenatate (GW642444M) for asthma and COPD.
Objectives: To compare the efficacy and safety of FF (dry powder) at 4 doses administered via a novel single-step activation inhaler in patients ≥12 years old with persistent uncontrolled asthma. Fluticasone propionate (FP) served as an active control.
Methods: In a randomised, double-blind, placebo-controlled, parallel group study, 598 patients received one of 6 treatments: FF (25, 50, 100 or 200mcg) OD, FP 100mcg twice daily or placebo for 8 weeks. The primary endpoint was change from baseline in trough (pre-dose) FEV₁ at Week 8.
Results: A dose response was observed for trough FEV₁ between FF 25–200mcg including and excluding placebo (linear trend analysis p<0.001 and p=0.03, respectively). At Week 8, relative to placebo FF 50–200mcg had significantly greater increases in trough FEV₁ from baseline (p<0.05) with FF 100mcg and 200mcg achieving a >200mL increase. Secondary endpoints PEF, symptom-free and rescue-free 24 hour periods supported the efficacy of FF 50–200mcg doses and FP. Overall, FF was well tolerated. The incidence of oral candidiasis was low (0–4%). 24-hour urinary cortisol excretion ratios (Week 8/baseline) were similar across treatments (FF 0.98–1.21 and placebo 1.04).
Conclusion: The data support the use of FF (100 and 200mcg) as a once-daily treatment in persistent uncontrolled asthma.
Funded by GSK (FFA109687; NCT00603382)

Rating:

Share or cite this content

Citations should be made in the following way:
E. D. Bateman, E. R. Bleecker, W. Busse, J. Lötvall, A. Woodcock, R. Forth, H. Medley, L. Jacques, B. Haumann (Cape Town, South Africa; Winston-Salem, Madison, RTP, United States Of America; Gothenburg, Sweden; Manchester, London, United Kingdom). Fluticasone furoate (FF), a once-daily inhaled corticosteroid (ICS), demonstrates dose-response efficacy in patients symptomatic on non-steroidal asthma therapy. Eur Respir J 2010; 36: Suppl. 54, 1166

Member's Comments

No comment yet.

Related content which might interest you: Fluticasone furoate (FF), an inhaled corticosteroid (ICS), demonstrates efficacy in asthma patients symptomatic on moderate doses of ICS therapy Source: Annual Congress 2010 - New treatments for asthma and COPD Year: 2010 Fluticasone furoate (FF), an inhaled corticosteroid (ICS), is efficacious in asthma patients symptomatic on low doses of ICS therapy Source: Annual Congress 2010 - New treatments for asthma and COPD Year: 2010 Fluticasone furoate (FF), a novel inhaled corticosteroid (ICS), demonstrates once-daily (OD) efficacy in asthma when dosed in the evening Source: Annual Congress 2010 - New treatments for asthma and COPD Year: 2010 Safety and tolerability of the novel inhaled corticosteroid (ICS) fluticasone furoate (FF) in combination with the long-acting beta2 agonist (LABA) vilanterol (VI) administered once daily (OD) in patients with asthma Source: Annual Congress 2012 - Asthma treatment: efficacy and safety Year: 2012 Safety of fluticasone furoate (FF), an inhaled corticosteroid in combination with vilanterol (VI), a long-acting beta agonist in management of COPD exacerbations Source: Annual Congress 2012 - COPD treatments: efficacy and safety Year: 2012 Efficacy of the novel inhaled corticosteroid, fluticasone furoate (FF)/long-acting beta2-agonist, vilanterol (VI) combination in reducing COPD exacerbations Source: Annual Congress 2012 - Trials in COPD: novel treatments and insights Year: 2012 Once-daily versus twice-daily administration of mometasone furoate dry powder inhaler (MF-DPI) improves lung function in children with asthma previously maintained on inhaled corticosteroids (ICS) Source: Eur Respir J 2004; 24: Suppl. 48, 164s Year: 2004 Inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) combination vs. high doses of ICS: efficacy and safety in patients (pts) with uncontrolled occupational asthma Source: International Congress 2017 – Techniques to treat asthma Year: 2017 Scientific rationale for inhaled combination therapy with long-acting β2-agonists and corticosteroids Source: Eur Respir J 2002; 19: 182-191 Year: 2002 Initiation of treatment with the salmeterol/fluticasone propionate (FP) combination product is better than inhaled steroid alone (FP) in asthmatic patients symptomatic on short-acting bronchodilator alone Source: Eur Respir J 2003; 22: Suppl. 45, 410s Year: 2003 Efficacy of fluticasone furoate (FF) as a monotherapy and in combination with vilanterol (VI) over 12 weeks in patients with persistent asthma Source: Annual Congress 2012 - Asthma treatment: efficacy and safety Year: 2012 Combination of inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA) versus similar ICS dose in children and adults with persistent asthma Source: Eur Respir J 2005; 26: Suppl. 49, 124s Year: 2005 Efficacy and safety of inhaled corticosteroid‘s (ICS) and long-acting beta-agonist‘s (LABA) combination in asthma (A) patients Source: Eur Respir J 2004; 24: Suppl. 48, 125s Year: 2004 Is the combination of long-acting β2-agonists (LABA) and inhaled steroids (ICS) superior to higher ICS dose in children and adults with persistent asthma? Source: Eur Respir J 2005; 26: Suppl. 49, 124s Year: 2005 First choice in persistent asthma: inhaled corticosteroids (ICS) or ICS + long-acting beta2-agonist (LABA) combination in steroid-naïve patients? Source: Annual Congress 2004 - Further pharmacological and clinical evidence for using long-acting β-agonists with inhaled corticosteroids Year: 2004 Salmeterol/fluticasone combination (SFC) is associated with improved asthma control compared with concurrent long-acting β2 agonists (LABA) and inhaled corticosteroids (ICS) or ICS alone Source: Eur Respir J 2003; 22: Suppl. 45, 235s Year: 2003 Late Breaking Abstract - Dose responses for topical efficacy and systemic activity, dose equivalence and relative therapeutic index for fluticasone furoate (FF), fluticasone propionate (FP) and budesonide (BUD) in asthmatic subjects. Source: International Congress 2019 – New towards old therapies in airway diseases Year: 2019 Triple combination of montelukast or tiotropium and inhaled corticosteroids plus long-acting ß2-agonist in persistent asthma Source: International Congress 2018 – Understanding the immunopathology that underlies airway obstructive diseases Year: 2018 24-h duration of the novel LABA vilanterol trifenatate in asthma patients treated with inhaled corticosteroids}, Source: Eur Respir J 2012; 40: 570-579 Year: 2012 The efficacy of inhaled fluticasone furoate (FF) and vilanterol (VI) administered in combination in asthma is comparable when administered in the morning or evening Source: Annual Congress 2012 - Asthma treatment: efficacy and safety Year: 2012