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Title: Results From First-of-its-Kind Study Show That Combination Therapy Significantly Reduces Pulmonary Inflammation in COPD

"Results From First-of-its-Kind Study Show That Combination Therapy Significantly Reduces Pulmonary Inflammation in COPD"

TORONTO, CANADA -- April 4, 2006 -- For the first time, a currently available treatment has been shown to reduce the bronchial inflammation present in chronic obstructive pulmonary disease (COPD).1 Results from a first-of-its-kind study, published in this month's edition of the American Journal of Respiratory and Critical Care Medicine (AJRCCM), show that combination therapy using salmeterol and fluticasone propionate (Advair®), significantly reduced inflammation in patients with COPD compared to placebo.1 The study is the largest multi-centre clinical trial in COPD to assess repeat bronchial biopsy and sputum samples in moderate to severe COPD patients. The authors suggest that the findings support the consideration that earlier treatment with combination therapy, than that proposed by current guidelines, could be helpful. COPD is the fourth leading cause of death in Canada, 2 with almost 10,000 men and women dying each year.3 Globally, it is the only leading cause of death that is increasing.4 Currently, more than 750,000 Canadians suffer from the disease, although it is expected that hundreds of thousands more have COPD yet remain undiagnosed.5 "The inflammation in the airways of COPD is very difficult to decrease," said Dr. Neil C. Barnes, lead investigator of the study from the Department of Respiratory Medicine, London Chest Hospital. "However, this study shows that the combination of fluticasone and salmeterol is able to decrease a broad range of inflammatory cells which we consider of importance in COPD. I hope that this will spur further research into the role of combination therapy in COPD." "These new data have important implications for the treatment of COPD, because until now, no available treatment has been shown to reduce these key inflammatory cells," says Dr. Francois Maltais, MD, respirologist at the Pneumology Center at Laval Hospital in Québec, commenting on the study results. "COPD treatment should aim to address both the symptoms and the underlying causes of the disease. This study suggests that synergy between salmeterol and fluticasone propionate could help achieve this goal." † About the Study The 13-week, double-blind, multi-centre study monitored bronchial biopsies and sputum from 140 patients with moderate to severe COPD. Patients included in the study were either current or former smokers and were randomized to either salmeterol/fluticasone propionate 50/500 mcg or placebo.1 The study found that treatment with salmeterol/fluticasone propionate significantly reduced the numbers of biopsy inflammatory markers compared with placebo: the absolute number of CD8+ cells was reduced by 36% (P =.001) and sputum differential neutrophils were reduced by 8.5% (P =.04).1 CD68+ cells were unaffected by combination treatment.1 The broad-spectrum anti-inflammatory effects were accompanied by improvements in lung function; significant improvements were seen in pre-bronchodilator forced expiratory volume in one second (FEV1) (P <.001) and fewer patients experienced a worsening of COPD symptoms that required a change in treatment (P =.025).1 A likely explanation for these effects is the synergy between salmeterol and fluticasone propionate when given in combination.1 Additional results from the study showed a significant reduction from baseline in total neutrophils (53%; p=0.046) and sputum total eosinophils. CD45+ and CD4+ cells were also reduced, as were cells expressing genes for tumour necrosis factor-alpha and interferon-gamma (all p ≤ 0.03). The findings of this study could have important implications for the treatment of COPD which is a multi-component disease, with inflammation present at the earliest stages. Inflammation of the lungs is caused by exposure to inhaled noxious particles and gases.6 About Salmeterol/Fluticasone Propionate The combination of salmeterol/fluticasone propionate dry powder for inhalation (Advair® 250 Diskus® and Advair® 500 Diskus®) is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema where the use of a combination product is considered appropriate. The most commonly occurring side effects in COPD were upper respiratory tract infection (12-17%), throat irritation (8-11%), headache (16-18%), musculoskeletal pain (9-12%) and oral candidiasis (7-10%). †Fluticasone propionate is not approved for the treatment of COPD in Canada. REFERENCES: 1. Barnes NC et al. on behalf of the SCO30005 study group. Anti Anti-inflammatory effects of salmeterol/fluticasone propionate in chronic obstructive lung disease. Am J Respir Crit Care Med 2006;173:736-43. 2. 2005.copd_reportcard. Chronic Obstructive Pulmonary Disease (COPD): A National Report Card. The Lung Association. 2005. Page 3. 3. Vermeire P. The burden of chronic obstructive pulmonary disease. Respir Med 2002: 96(Suppl C): S3-S10. 4. Hurd, S. International efforts directed at attacking the problem of COPD. Chest 2000; 117: 336S-338S. 5. The Lung Association: What you need to know about COPD http://www.lung.ca/breathworks/D01.html Accessed March 20, 2006. 6. GOLDWkshp05Clean[1]. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease Updated 2005, Executive summary. http://www.goldcopd.com/GuidelineItem.asp?intId=989, last accessed 22 March 2006. Page 6. SOURCE: GlaxoSmithKline Inc.

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