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

Jones, PW; Anderson, JA; Calverley, PM; Celli, BR; Ferguson, GT; Jenkins, C; Yates, JC; Vestbo, J; Spencer, MD; TORCH investigators, (2011) Health status in the TORCH study of COPD: treatment efficacy and other determinants of change. RESPIRATORY RESEARCH, 12 (71). ISSN 1465-993X https://doi.org/10.1186/1465-9921-12-71
SGUL Authors: Jones, Paul Wyatt

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Abstract

BACKGROUND: 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 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. 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.

Item Type: Article
Additional Information: © 2011 Jones et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Keywords: Adrenergic beta-2 Receptor Agonists, Age Factors, Aged, Albuterol, Androstadienes, Asia, Bronchodilator Agents, Disease Progression, Double-Blind Method, Drug Combinations, Europe, Female, Forced Expiratory Volume, Glucocorticoids, Health Status, Health Status Indicators, Humans, Lung, Male, Middle Aged, Predictive Value of Tests, Pulmonary Disease, Chronic Obstructive, Quality of Life, Questionnaires, Risk Assessment, Risk Factors, Severity of Illness Index, Time Factors, Treatment Outcome, United States, Science & Technology, Life Sciences & Biomedicine, Respiratory System, COPD quality of life, OBSTRUCTIVE PULMONARY-DISEASE, lung function, QUALITY-OF-LIFE, FLUTICASONE PROPIONATE, SALMETEROL/FLUTICASONE PROPIONATE, LUNG-FUNCTION, EXACERBATION, DECLINE, TRIAL, QUESTIONNAIRE, DETERIORATION
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Journal or Publication Title: RESPIRATORY RESEARCH
ISSN: 1465-993X
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Dates:
DateEvent
31 May 2011Published
Web of Science ID: WOS:000291875900001
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URI: http://openaccess.sgul.ac.uk/id/eprint/624
Publisher's version: https://doi.org/10.1186/1465-9921-12-71

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