PURPOSE: COPD is associated with measurable and progressive deterioration in health status. The study investigated whether fluticasone propionate/salmeterol (FSC) could significantly impact health status over 3 years.
METHODS: Of the 6112 subjects in the TORCH mortality study in COPD, health status measured by St George’s Respiratory Questionnaire (SGRQ) was assessed as a secondary endpoint in 4951 patients (mean age 65yrs, 74% males, 44% predicted post-bronchodilator FEV1; 3.7% reversibility to albuterol, 44% current smokers) from countries with a validated questionnaire. Patients received fluticasone propionate (FP) 500mcg (n=1248), salmeterol (SAL) 50mcg (n=1232), FSC 500/50 (n=1240), or placebo (n=1231) bid via Diskus(R); in a double-blind study. Scores were analysed as mean differences over the 3-year study period. Clinical significance was investigated by a responder analysis of patients categorized as having clinically significant improvement (−4 units) or deterioration (+ 4 units) or maintained health status (>−4 units & <+4 units).
RESULTS: Mean baseline SGRQ Total Score was 49-50 units across treatment groups. Adjusted changes from baseline to 156 weeks were FSC −1.2, SAL 1, FP −0.2 and placebo 2.1. In terms of differences between treatment groups, FSC produced an adjusted mean difference of −3.1 units vs placebo (p<0.001), −2.2 units vs SAL (p<0.001) and −1.2 units vs FP (p=0.017). FSC also showed the greatest treatment benefits over placebo in all domain scores (Symptoms −3.6 units, Activity −2.8 units, Impact −3.2 units, all p<0.001). In the responder analysis FSC patients were more likely to be improved or maintained compared with placebo (58% vs 42% improving or maintained, p<0.001). The same was true for FSC vs its components (SAL=49%, FP=52% improving or maintained, p≤0.006 vs FSC).
CONCLUSION: TORCH, the largest study of pharmacotherapy in COPD, showed FSC improved and sustained health status compared with placebo and components.
CLINICAL IMPLICATIONS: A key goal for patients with COPD is to improve and maintain health status, a goal achieved by FSC over 3 years.
DISCLOSURE: Paul Jones, Grant monies (from industry related sources) This study is funded by a grant from GlaxoSmithKline. Departments of BC, CJ, PC, GF, JV, receive funding from GlaxoSmithKline for specific research projects; Employee JA, MS and JY are employees of GlaxoSmithKline; Consultant fee, speaker bureau, advisory committee, etc. PJ, PC, BC, GF, CJ, JV and NP have been speakers and consultants for companies including GSK, Pfizer, AstraZeneca, Boehringer Ingelheim; Other JV’s wife was until 2004 a GSK employee; Product/procedure/technique that is considered research and is NOT yet approved for any purpose, FSC 500/50 dose currently unlicensed for COPD in U.S.