Health status deterioration in patients with chronic obstructive pulmonarydisease

This study examined health status decline in patients with chronic obstruct ive pulmonary disease (COPD). Data are from the Inhaled Steroids in Obstruc tive Lung Disease (ISOLDE) trial. After an 8-wk run-in, 751 patients (566 m ale), mean age 64 yr, were randomized to receive fluticasone propionate (FP ) 500 mug twice daily (376 patients) or placebo (375 patients). Mean baseli ne postbronchodilator FEV1 was 50 +/- 15% predicted. Patients completed the St George's Respiratory Questionnaire (SGRQ) and the Short-Form 36 (SF-36) at baseline and every 6 mo for 3 yr. FEV1 and smoking status were assessed at baseline and at 3-mo intervals. A total of 387 (212 FP) patients comple ted the trial. All SGRQ components (p = 0.03 to 0.004) and Physical Functio n, Mental Health, Energy/Vitality, and Physical Role Limitation scales of t he SF-36 (p = 0.05 to 0.005) deteriorated faster in the placebo group. FEV, and SGRQ scores correlated at baseline values (r = -0.25, p < 0.0001), as did change in FEV1 and change in SGRQ (<Delta> r = -0.24, p < 0.0001). At b aseline values smokers had worse SGRQ Total, Symptoms, and Impacts scores t han ex-smokers. This difference was maintained throughout the study. Smokin g status did not influence the rate of decline in health status. The SGRQ T otal scores of FP-treated patients took 59% longer than placebo to deterior ate by a clinically significant amount. We conclude that health status decl ine in moderate to severe COPD can be reduced by high-dose fluticasone.