Back to Search
Start Over
Health status in the TORCH study of COPD: treatment efficacy and other determinants of change.
- Source :
- Respiratory Research; May2011, Vol. 12 Issue 5, p1-8, 8p, 1 Chart, 5 Graphs
- Publication Year :
- 2011
-
Abstract
- <bold>Background: </bold>Little is known about factors that determine health status decline in clinical trials of COPD.<bold>Objectives: </bold>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.<bold>Methods: </bold>St George's Respiratory Questionnaire (SGRQ) was administered at baseline then every 6 months.<bold>Measurements and Main Results: </bold>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.<bold>Conclusions: </bold>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.<bold>Trial Registration: </bold>ClinicalTrials.gov: NCT00268216. [ABSTRACT FROM AUTHOR]
- Subjects :
- OBSTRUCTIVE lung diseases
SALMETEROL
FLUTICASONE propionate
HEALTH status indicators
CLINICAL trials
THERAPEUTIC use of glucocorticoids
OBSTRUCTIVE lung disease diagnosis
STEROID drugs
ADRENERGIC beta agonists
DISEASE progression
RESEARCH
PREDICTIVE tests
COMBINATION drug therapy
ALBUTEROL
LUNGS
TIME
AGE distribution
RESEARCH methodology
EVALUATION research
MEDICAL cooperation
BRONCHODILATOR agents
SEVERITY of illness index
RISK assessment
TREATMENT effectiveness
COMPARATIVE studies
RANDOMIZED controlled trials
QUALITY of life
FORCED expiratory volume
BLIND experiment
QUESTIONNAIRES
Subjects
Details
- Language :
- English
- ISSN :
- 14659921
- Volume :
- 12
- Issue :
- 5
- Database :
- Complementary Index
- Journal :
- Respiratory Research
- Publication Type :
- Academic Journal
- Accession number :
- 93607225
- Full Text :
- https://doi.org/10.1186/1465-9921-12-71