Health status in the TORCH study of COPD: treatment efficacy and other determinants of change

Abstract

BackgroundLittle is known about factors that determine health status decline in clinical trials of COPD.ObjectivesTo examine health status changes over 3 years in the TORCH study of salmeterol+fluticasone propionate (SFC) vs. salmeterol alone, fluticasone propionate alone or placebo.MethodsSt George's Respiratory Questionnaire (SGRQ) was administered at baseline then every 6 months.Measurements and Main ResultsData 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 FEV1 and SGRQ did not differ in different world regions, but patients in Asia-Pacific showed a large improvement in score that was unrelated to FEV1 change.ConclusionsIn 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.Trial RegistrationClinicalTrials.gov: NCT00268216

Changes in Body Composition in Patients with Chronic Obstructive Pulmonary Disease: Do They Influence Patient-Related Outcomes?

“…A decline in skeletal muscle mass in underweight patients and an increase in FM in overweight and obese patients were independent determinants for clinically significant deterioration in health status over 3 years. The overall change in health status over 3 years was small (mean change 0.84 ± 14.43 points) and comparable with recent results from the TORCH study, where SGRQ total score remained stable and worsened by about 2 points over 3 years in both the treated and the placebo groups [28]. In addition, comparable results were shown in the UPLIFT trial, as the SGRQ total score showed a worsening of about 1 point over 3 years [29].…”

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