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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 investigato - Respir. Res. (2011)

Bottom Line: 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.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Cardiac and Vascular Sciences, St George's Hospital, University of London, London, UK. pjones@sgul.ac.uk

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.

Trial registration: ClinicalTrials.gov: NCT00268216.

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Related in: MedlinePlus

Mean change in SGRQ Total score at 3 years by region for patients treated by placebo and SFC. A lower score indicates better health. A test for an interaction between region and treatment effect was not significant (p = 0.16).
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Figure 2: Mean change in SGRQ Total score at 3 years by region for patients treated by placebo and SFC. A lower score indicates better health. A test for an interaction between region and treatment effect was not significant (p = 0.16).

Mentions: There were considerable regional variations in change in total SGRQ score (Figure 2). After 3 years, placebo-treated patients who completed the study were worse than at baseline in three regions, the USA, Western Europe and other, unchanged in Eastern Europe, and improved in Asia-Pacific. Numerically, patients receiving SFC improved in all regions except the USA. However, the actual treatment differences between SFC and placebo were fairly consistent, ranging from 1.8 to 5.0 at 3 years. A test for interaction between region and treatment effect was not significant (p = 0.16).


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 investigato - Respir. Res. (2011)

Mean change in SGRQ Total score at 3 years by region for patients treated by placebo and SFC. A lower score indicates better health. A test for an interaction between region and treatment effect was not significant (p = 0.16).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3117702&req=5

Figure 2: Mean change in SGRQ Total score at 3 years by region for patients treated by placebo and SFC. A lower score indicates better health. A test for an interaction between region and treatment effect was not significant (p = 0.16).
Mentions: There were considerable regional variations in change in total SGRQ score (Figure 2). After 3 years, placebo-treated patients who completed the study were worse than at baseline in three regions, the USA, Western Europe and other, unchanged in Eastern Europe, and improved in Asia-Pacific. Numerically, patients receiving SFC improved in all regions except the USA. However, the actual treatment differences between SFC and placebo were fairly consistent, ranging from 1.8 to 5.0 at 3 years. A test for interaction between region and treatment effect was not significant (p = 0.16).

Bottom Line: 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.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Cardiac and Vascular Sciences, St George's Hospital, University of London, London, UK. pjones@sgul.ac.uk

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.

Trial registration: ClinicalTrials.gov: NCT00268216.

Show MeSH
Related in: MedlinePlus