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
Highlights
Little is known about factors that determine health status decline in clinical trials of chronic obstructive pulmonary disease (COPD)
We provide data about the effect of therapy on the St George’s Respiratory Questionnaire (SGRQ) domains, and an analysis of demographic and diseaserelated factors that may influence long-term changes in health status
Of the 6112 patients that formed the primary efficacy population, 4951 provided SGRQ data that met the criteria for inclusion in the health outcomes population in 28 of 42 countries that participated in Towards a Revolution in COPD Health (TORCH)
Summary
Little is known about factors that determine health status decline in clinical trials of COPD. Disease-specific questionnaires like the St George’s Respiratory Questionnaire (SGRQ) reflect a wide range of different health impacts in COPD [1], are and 4-year Understanding Potential Long-term Impacts on Function with Tiotropium (UPLIFT) studies have both reported health status gains that lasted the entire duration of the study [9,10]. The results obtained with the total SGRQ score have been reported [9]. In this analysis, we provide data about the effect of therapy on the SGRQ domains, and an analysis of demographic and diseaserelated factors that may influence long-term changes in health status
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