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

Respiratory Research

Michael D Spencer⁷  Jørgen Vestbo³  Julie C Yates⁴  Christine Jenkins⁶  Gary T Ferguson²  Bartolome R Celli¹  Peter MA Calverley⁸  Julie A Anderson⁷  Paul W Jones⁵ 

[1] Pulmonary Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA;Pulmonary Research, Institute of Southeast Michigan, Livonia, MI, USA;North West Lung Centre, Wythenshawe Hospital, Manchester, UK and Department of Cardiology & Respiratory Medicine, Hvidovre Hospital, Hvidovre, Denmark;Respiratory Medicine Development Center, GlaxoSmithKline, Research Triangle Park, NC, USA;Department of Cardiac and Vascular Sciences, St George's Hospital, University of London, London, UK;Clinical Management Research Group, Woolcock Institute of Medical Research, Sydney, Australia;Respiratory Medicine Development Centre, GlaxoSmithKline, Greenford, UK;School of Clinical Science, University Hospital Aintree, Liverpool, UK

关键词: lung function;    health status;    quality of life;    COPD;   

Others  :  796853
DOI  :  10.1186/1465-9921-12-71

 received in 2011-02-09, accepted in 2011-05-31,  发布年份 2011

【 摘 要 】

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.

Trial Registration

ClinicalTrials.gov: NCT00268216

【 授权许可】

   
2011 Jones et al; licensee BioMed Central Ltd.

【 图 表 】

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