The Toward a Revolution in COPD Health (TORCH) study investigated the effects of combined salmeterol, a B-agonist, and fluticasone propiniate, an inhaled cortical steroid, either alone or in combination, on mortality, exacerbations, health-related quality of life and rate of decline in lung function as measure by forced expiratory volume in one second (FEV1) in patients with COPD.
The study has been published in the second issue for August of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
"Pharmacotherapy with salmeterol plus fluticasone propionate, or the components, reduces the rate of decline on FEV1 in patients with moderate to severe COPD, thus slowing disease progression," said Bartolome R. Celli, M.D., lead author of the study and professor at Tufts University School of Medicine.
"To date, smoking cessation is the only intervention that has conclusively been shown to alter the rate of decline in FEV1," said Dr. Celli.
This is the first demonstration of an effective pharmacothrerapy in COPD.
The TORCH study randomized more than 6,000 patients with moderate to severe COPD from 42 countries to receive either salmeterol, fluticasone propionate, the two in combination, or placebo.
After baseline FEV1 was recorded, patients were re-evaluated every 24 weeks to determine the rate of decline in FEV1.
"The rate of decline in FEV1 was slowest in patients on SFC and fastest in those randomized to the placebo arm," said Dr. Celli.
"From week 24 onward, the adjusted rate of decline in FEV1 was 39ml/year for SFC, 42 ml/year for both SAL and FP and 55 ml/year for placebo," the researcher added.
Although the study was not formally powered to detect differences in rate of decline of FEV1, the results were highly significant. The rate of decline in treatment groups was similar across a number of variables, including sex, age, ethnicity and body mass index. Furthermore, the slower rate of decline in FEV1 appeared to be associated with a lower risk of exacerbation.