Health Status in the TORCH Study of COPD: Treatment Efficacy and Other Determinants of Change
Jones, Paul W
Anderson, Julie A.
Calverley, Peter MA
Ferguson, Gary T
Yates, Julie C
Spencer, Michael D
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CitationJones, Paul W., Julie A. Anderson, Peter MA Calverley, Bartolome R. Celli, Gary T. Ferguson, Christine Jenkins, Julie C. Yates, Jorgen Vestbo, and Michael D. Spencer. 2011. Health status in the TORCH study of COPD: Treatment efficacy and other determinants of change. Respiratory Research 12(1): 71.
AbstractBackground: Little is known about factors that determine health status decline in clinical trials of COPD. Objectives: To examine health status changes over 3 years in the TORCH study of salmeterol+fluticasone propionate (SFC) vs. salmeterol alone, fluticasone propionate alone or placebo. Methods: St George’s Respiratory Questionnaire (SGRQ) was administered at baseline then every 6 months. Measurements and Main Results: Data from 4951 patients in 28 countries were available. SFC produced significant improvements over placebo in all three SGRQ domains during the study: (Symptoms -3.6 [95% CI -4.8, -2.4], Activity -2.8 [95% CI -3.9, -1.6], Impacts -3.2 [95% CI -4.3, -2.1]) but the pattern of change over time differed between domains. SGRQ deteriorated faster in patients with Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages III & IV relative to GOLD stage II (p < 0.001). There was no difference in the relationship between
deterioration in SGRQ Total score and forced expiratory volume in one second (FEV1) decline (as % predicted) in men and women. Significantly faster deterioration in Total score relative to FEV1 % predicted was seen in older patients (≥ 65 years) and there was an age-related change in Total score that was independent of change in FEV1. The relationship between deterioration in \(FEV_1\) and SGRQ did not differ in different world regions, but patients in Asia-Pacific showed a large improvement in score that was unrelated to \(FEV_1\) change. Conclusions: In addition to treatment effects, health status changes in clinical trials may be influenced by demographic and disease-related factors. Deterioration in health status appears to be fastest in older persons and those with severe airflow limitation.
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