THE TOWARDS A REVOLUTION IN COPD HEALTH (TORCH) STUDY: FLUTICASONE PROPIONATE/SALMETEROL REDUCES THE RATE OF EXACERBATIONS OVER 3 YEARS

Abstract

PURPOSE: COPD exacerbations are associated with worse health status, increased hospitalisations and premature death. Existing studies have demonstrated that fluticasone propionate/salmeterol (FSC) significantly reduces exacerbations over 1 year. This study investigated whether FSC could significantly reduce exacerbations over 3 years compared with placebo or either component alone. METHODS: This was a 3 year, double-blind, placebo controlled multi-center trial of 6112 (intention to treat population) patients with moderate to severe COPD from 42 countries (mean age 65 yrs, 76% males, 44% predicted post-bronchodilator FEV1, 43% current smokers). Patients were randomised to receive FP 500mcg (n=1534), SAL 50mcg (n=1521), FSC 500/50 (n=1533), or placebo (n=1524) bid via Diskus(R). Exacerbations, a secondary outcome in the study, were defined as moderate if they were treated with antibiotics and/or systemic corticosteroids (SCS) and severe if hospitalised. RESULTS: Over 13,000 exacerbations were recorded in the study. The mean rate of moderate/severe exacerbations per annum was 1.13 (placebo), 0.97 (SAL), 0.93 (FP) and 0.85 (FSC). Greatest reductions in rate of moderate/severe exacerbations were achieved with FSC (25% reduction vs placebo, p<0.001; 12% reduction vs SAL, p=0.002; 9% reduction vs FP, p=0.024). Both components were also significantly more effective than placebo (15% and 18% reduction vs placebo for SAL and FP respectively, both p<0.001). Further, there was a 43% reduction in rate of exacerbations treated with SCS for FSC vs placebo (p<0.001), 29% reduction vs SAL (p<0.001) and 13% vs FP (p=0.017). FSC reduced the rate of severe exacerbations by 17% (p=0.028 vs placebo). CONCLUSION: In this large world-wide trial, inhaled salmeterol, fluticasone propionate and fluticasone propionate/salmeterol significantly reduced moderate/severe exacerbations over 3 years compared with placebo. Significantly greater reductions were seen with FSC compared with either component alone, especially for exacerbations requiring SCS.