PT  - JOURNAL ARTICLE
AU  - Edward M. Kerwin
AU  - Catherine Scott-Wilson
AU  - Lisa Sanford
AU  - Stephen I. Rennard
AU  - Alvar Agusti
AU  - Neil Barnes
AU  - Courtney Crim
TI  - Lung function effects and safety of fluticasone furoate (FF)/vilanterol (VI) in patients with COPD: Low-mid dose assessment
DP  - 2012 Sep 01
TA  - European Respiratory Journal
PG  - 3082
VI  - 40
IP  - Suppl 56
4099  - http://erj.ersjournals.com/content/40/Suppl_56/3082.short
4100  - http://erj.ersjournals.com/content/40/Suppl_56/3082.full
SO  - Eur Respir J2012 Sep 01; 40
AB  - 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).