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| |  ATS: Fluticasone Propionate (Flovent) Improves Quality Of Life In Patients With Chronic Obstructive Pulmonary Disease By Guenther Krueger Special to DG News
SAN FRANCISCO, CA -- May 23, 2001 -- The primary goal of treatment for patients with chronic obstructive pulmonary disease (COPD) is to improve not only longevity, but also the quality of life. What is deemed important is how people feel, not only physically, but also in terms of their emotional and psychological well-being. In this study, lead author Dr. H. M. Edin with GlaxoSmithKline of North Carolina, attempted to compare the effects on COPD-related quality of life in patients receiving fluticasone propionate (Flovent) versus placebo. Patients had COPD as defined by the American Thoracic Society. The mean age was 64.4, almost all were Caucasian, 69 percent were male, 55 percent were former smokers. Fluticasone propionate was given 250 mcg (FP 250) or 500 mcg (FP 500) twice daily using the Diskus delivery system. These were then compared with placebo (n=630). Quality of life was evaluated using the Chronic Respiratory Disease Questionnaire (CRDQ) in two 24-week, randomized, double-blind, placebo-controlled, parallel-group trials (n=1368). The CRDQ is a 20-item, disease-specific instrument with four domains: dyspnea and fatigue, emotional function, and mastery using an emotional summary. It was administered at baseline and treatment weeks 2, 4, 8 and then again at endpoint. The scoring on the CRDQ is the sum of the 20 items with scores ranging from 20 to 140. Changes from baseline were considered clinically meaningful if they met or exceeded the following criteria: 10 points in overall score; 2.5 points in dyspnea; 2.0 points in fatigue; 3.5 points in emotional function; and 2.0 points in mastery. Mean changes in overall CRDQ score were significantly greater in both the FP 250 and FP 500 groups compared with placebo. The improvement from baseline in the FP 500 group approached the clinically meaningful threshold. In this group, 42 percent of patients experience clinically meaningful improvements compared to only 32 percent in the placebo group (p=0.025). In addition, both of the treatment groups demonstrated clinically meaningful improvements in dyspnea that were significantly higher that placebo. This was also the case for the physical summary that measures dyspnea and fatigue within the CRDQ. In fact, all parameters of the score improved, including the emotional function and mastery domains. The study concludes that there is clearly a significant improvement in quality of life as self-reported by patients with COPD when they use this corticosteroid. Related Link: fluticasone propionate (Flovent).
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