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Published ahead of print on May 29, 2008, doi:10.1164/rccm.200712-1869OC

Am. J. Respir. Crit. Care Med., Volume 178, Number 4, August 2008, 332-338

A more recent version of this article appeared on August 15, 2008
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Submitted on December 21, 2007
Accepted on May 29, 2008

Effect of Pharmacotherapy on Rate of Decline of Lung Function in COPD: Results from the TORCH Study

Bartolome R Celli1*, Nicola E Thomas2, Julie A Anderson2, Gary T Ferguson3, Christine Jenkins4, Paul W Jones5, Jorgen Vestbo6, Katharine Knobil2, Julie C Yates7, and Peter MA Calverley8

1 Pulmonary and Critical Care Division, Tufts University School of Medicine, Caritas-St Elizabeth's Medical Center, Boston, MA, USA, 2 Respiratory Medicines Centre, GSK, Greenford, Middlesex, United Kingdom, 3 Pulmonary Research, Institute of Southeast Michigan, Livonia, MI, USA, 4 Woolcock Institute of Medical Research, Camperdown, NSW, Australia, 5 Division of Cardiac and Vascular Science, St George's University of London, London, United Kingdom, 6 Cardiology and Respiratory Medicine 253, Hvidovre Hospital, Hvidovre, Denmark; Noth West Lung Centre, Wythenshawe Hospital, Manchester, United Kingdom, 7 Respiratory Medicines Centre, GSK, Research Triangle Park, USA, 8 Department of Medicine, University Hospital Aintree, Liverpool, United Kingdom

* To whom correspondence should be addressed. E-mail: bcelli{at}copdnet.org.

Rationale: Chronic obstructive pulmonary disease (COPD) is characterized by an accelerated decline in lung function. No drug has been shown conclusively to reduce this decline. Objective: In a post-hoc analysis of the towards a Revolution in COPD Health (TORCH) study we investigated the effects of combined salmeterol 50µg plus fluticasone propionate 500µg, either component alone or placebo, on the rate of post-bronchodilator forced expiratory volume in one second (FEV1) decline in patients with moderate-to-severe COPD. Methods: Randomized, double-blind, placebo-controlled study conducted from September 2000 to November 2005 in 42 countries. Of 6112 patients from the efficacy population, 5343 were included in this analysis. Measurements and main results: Spirometry was measured every 24 weeks for 3 years. There were 26,539 on-treatment observations. The adjusted rate of decline in FEV1 was 55mL/year for placebo, 42mL for salmeterol, 42mL for fluticasone propionate and 39mL/year for salmeterol plus fluticasone propionate. Salmeterol plus fluticasone propionate reduced the rate of FEV1 decline by 16mL/year compared with placebo (95% CI, 7 to 25; P<0.001). The difference was smaller for fluticasone propionate and salmeterol compared with placebo (13mL/year, 95% CI,5 to 22; P=0.003). Rates of decline were similar among the active treatment arms. FEV1 declined faster in current smokers and patients with a lower body mass index, and varied between world regions. Patients who exacerbated more frequently had a faster FEV1 decline. Conclusions: Pharmacotherapy with salmeterol plus fluticasone propionate, or the components, reduces the rate of decline of FEV1 in patients with moderate-to severe COPD, thus slowing disease progression. Clinical trials information available at www.clinicaltrials.gov, i.d.# NCT00268216.
Key words: FEV1, salmeterol, fluticasone propionate, disease progression




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