Source: Annual Congress 2012 - New bronchodilators and other novel drugs for asthma and COPD
Disease area: Airway diseases

Abstract

Rationale: FF/VI is in development as a novel once-daily (OD) inhaled corticosteroid/long-acting beta₂ agonist combination therapy for COPD.
Objective: To evaluate the efficacy and safety of FF/VI (100/25 and 50/25mcg) vs placebo (PBO), FF (100mcg), and VI (25mcg), given OD via a novel dry powder inhaler for 168 days in moderate-severe COPD patients.
Methods: A multicentre, randomised, PBO-controlled, double-blind, parallel-group study (N=1030 (ITT)). Co-primary endpoints: weighted mean (wm) FEV₁ 0–4h (Day 168) to assess the contribution of VI, and trough FEV₁ (Day 169) to assess the contribution of FF and 24h duration of VI. Additional endpoints included CRQ-SAS dyspnoea and safety.
Results: Co-primary endpoints: see Figure. FF/VI 100/25 was numerically superior to components on dyspnoea score (treatment differences from PBO =0.30 vs 0.06 [FF] and 0.14[VI]). On-treatment AEs were more frequent with active treatment (54–60%) than PBO (48%). There were no treatment effects on 24h urinary cortisol, laboratory values, or cardiac monitoring parameters.

Conclusion: Addition of VI to FF produced a clinically significant improvement in wmFEV₁ (0-4h). Addition of FF to VI provided numerical improvements only in trough FEV₁. Combination therapy was superior to PBO for both co-primary endpoints. All treatments were well tolerated.
Funded by GSK (HZC112206; NCT01053988).

Rating:

Share or cite this content

Citations should be made in the following way:
E.M. Kerwin, C. Scott-Wilson, L. Sanford, S.I. Rennard, A. Agusti, N. Barnes, C. Crim (Medford, Uxbridge, London, United Kingdom; Research Triangle Park, Omaha, United States Of America; Barcelona, Spain). Lung function effects and safety of fluticasone furoate (FF)/vilanterol (VI) in patients with COPD: Low-mid dose assessment. Eur Respir J 2012; 40: Suppl. 56, 3082

Member's Comments

No comment yet.

Related content which might interest you: Lung function effects and safety of fluticasone furoate (FF)/vilanterol (VI) in patients with COPD: Mid-high dose assessment Source: Annual Congress 2012 - Trials in COPD: novel treatments and insights 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 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 Effect of fluticasone furoate (FF)/vilanterol (VI) once daily (OD) on risk of severe exacerbations in asthma Source: Annual Congress 2012 - Trials in asthma: asthma exacerbations and severe asthma 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 and safety of fluticasone furoate (FF)/vilanterol (VI) compared with fluticasone propionate/salmeterol combination (FP/SAL) in adults and adolescents with persistent asthma Source: Annual Congress 2012 - Trials in asthma: asthma exacerbations and severe asthma Year: 2012 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 Population pharmacokinetic (PK) analysis of fluticasone furoate (FF)/umeclidimium (UMEC)/vilanterol (VI) via a single inhaler in patients with COPD (FULFIL) Source: International Congress 2017 – Management of COPD Year: 2017 Efficacy and safety of fluticasone furoate (FF)/vilanterol (VI) once daily (OD) for 24 weeks in persistent asthma Source: Annual Congress 2012 - Trials in asthma: asthma exacerbations and severe asthma 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 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 The absolute bioavailability of fluticasone furoate (FF) and vilanterol (VI) trifenatate following inhaled administration in combination in healthy subjects Source: Annual Congress 2011 - Drug delivery and pharmacokinetics II Year: 2011 Efficacy of fluticasone furoate (FF)/vilanterol (VI) or FF alone in asthma patients with differing eosinophil (eos) levels Source: International Congress 2015 – New data on established treatments for asthma, COPD and bronchiectasis Year: 2015 Efficacy of fluticasone furoate (FF) and vilanterol (VI), separately and in combination (FF/VI), in an allergen challenge model Source: Annual Congress 2012 - Treatment of asthma, bronchiectasis and cough: inhaler use Year: 2012 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 Lung function normalization with indacaterol/glycopyrronium/mometasone furoate in patients with asthma Source: International Congress 2019 – Clinical studies of asthma treatments Year: 2019 Safety and efficacy of fluticasone furoate/vilanterol trifenatate (FFVI) in COPD patients Source: Annual Congress 2010 - Bronchodilators in airways disease Year: 2010 Pharmacokinetic (PK) analysis of fluticasone furoate (FF), umeclidinium (UMEC) and vilanterol (VI) following triple therapy in healthy subjects Source: International Congress 2014 – Asthma and COPD management Year: 2014 The safety, tolerability, pharmacodynamics and pharmacokinetics of inhaled fluticasone furoate (FF) and vilanterol (VI) are unaffected by administration in combination Source: Annual Congress 2011 - Drug delivery and pharmacokinetics I Year: 2011 Pharmacokinetic (PK) analysis of fluticasone furoate (FF), umeclidinium (UMEC) and vilanterol (VI) following triple therapy at two UMEC doses in healthy subjects Source: International Congress 2014 – Rationale behind respiratory drug development Year: 2014