TY - JOUR
T1 - The TORCH (TOwards a Revolution in COPD Health) survival study protocol
AU - Vestbo, J.
AU - Calverley, P.
AU - Celli, B.
AU - Ferguson, G.
AU - Jenkins, C.
AU - Jones, P.
AU - Pauwels, R.
AU - Pride, N.
AU - Anderson, J.
AU - Devoy, M.
AU - Cherniack, R.
AU - Similowski, T.
AU - Cleland, J.
AU - Whitehead, A.
AU - Wise, R.
AU - McGarvey, L.
AU - John, M.
PY - 2004/8
Y1 - 2004/8
N2 - Only long-term home oxygen therapy has been shown in randomised controlled trials to increase survival in chronic obstructive pulmonary disease (COPD). There have been no trials assessing the effect of inhaled corticosteroids and long-acting bronchodilators, alone or in combination, on mortality in patients with COPD, despite their known benefit in reducing symptoms and exacerbations. The "TOwards a Revolution in COPD Health" (TORCH) survival study is aiming to determine the impact of salmeterol/fluticasone propionate (SFC) combination and the individual components on the survival of COPD patients. TORCH is a multicentre, randomised, double-blind, parallel-group, placebo-controlled study. Approximately 6,200 patients with moderate-to-severe COPD were randomly assigned to b.i.d. treatment with either SFC (50/500 μg), fluticasone propionate (500 μg), salmeterol (50 μg) or placebo for 3 yrs. The primary end-point is all-cause mortality; secondary end-points are COPD morbidity relating to rate of exacerbations and health status, using the St George's Respiratory Questionnaire. Other end-points include other mortality and exacerbation end-points, requirement for long-term oxygen therapy, and clinic lung function. Safety end-points include adverse events, with additional information on bone fractures. The first patient was recruited in September 2000 and results should be available in 2006. This paper describes the "TOwards a Revolution in COPD Health" study and explains the rationale behind it. © ERS Journals Ltd 2004.
AB - Only long-term home oxygen therapy has been shown in randomised controlled trials to increase survival in chronic obstructive pulmonary disease (COPD). There have been no trials assessing the effect of inhaled corticosteroids and long-acting bronchodilators, alone or in combination, on mortality in patients with COPD, despite their known benefit in reducing symptoms and exacerbations. The "TOwards a Revolution in COPD Health" (TORCH) survival study is aiming to determine the impact of salmeterol/fluticasone propionate (SFC) combination and the individual components on the survival of COPD patients. TORCH is a multicentre, randomised, double-blind, parallel-group, placebo-controlled study. Approximately 6,200 patients with moderate-to-severe COPD were randomly assigned to b.i.d. treatment with either SFC (50/500 μg), fluticasone propionate (500 μg), salmeterol (50 μg) or placebo for 3 yrs. The primary end-point is all-cause mortality; secondary end-points are COPD morbidity relating to rate of exacerbations and health status, using the St George's Respiratory Questionnaire. Other end-points include other mortality and exacerbation end-points, requirement for long-term oxygen therapy, and clinic lung function. Safety end-points include adverse events, with additional information on bone fractures. The first patient was recruited in September 2000 and results should be available in 2006. This paper describes the "TOwards a Revolution in COPD Health" study and explains the rationale behind it. © ERS Journals Ltd 2004.
KW - Chronic obstructive pulmonary disease
KW - Fluticasone propionate
KW - Mortality
KW - Protocol
KW - Salmeterol
KW - Study design
U2 - 10.1183/09031936.04.00120603
DO - 10.1183/09031936.04.00120603
M3 - Article
SN - 0903-1936
VL - 24
SP - 206
EP - 210
JO - European Respiratory Journal
JF - European Respiratory Journal
IS - 2
ER -