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BTS: Budesonide/ Eformoterol Combination Inhaler Effective In Chronic Obstructive Pulmonary Disease New data show that budesonide/eformoterol reduces exacerbations and improves lung function in patients with moderate to severe COPD LONDON, ENGLAND -- December 9, 2002 -- Budesonide and eformoterol - given in a single inhaler - has been shown to reduce exacerbations by almost 30% in patients with moderate to severe chronic obstructive pulmonary disease (COPD) compared to placebo.1,2 "COPD can be a very distressing disease, particularly for patients who suffer from exacerbations that are so severe they require medical intervention," said Professor Peter Calverley, consultant chest physician at University Hospital Aintree, Liverpool, who presented the findings from one of the studies. "These studies show that patients given budesonide/eformoterol suffered significantly fewer exacerbations, and even though their disease was moderate to severe, their lung function improved." Budesonide is an inhaled corticosteroid that acts to reduce inflammation of the airways, while eformoterol is a long-acting ß2-agonist that has a rapid and long-lasting bronchodilatory effect. Symbicort® Turbohaler® combines the two drugs in a single inhaler and is available in 200/6 and 100/6 strength. It is already successfully used for the maintenance treatment of asthma in adults, adolescents and children aged 6 and over (100/6µg only).3 In one randomized, double-blind, active-controlled study1, 1,022 patients with moderate to severe COPD and a history of exacerbations had their condition optimised with eformoterol Turbohaler (9 mg bid) and oral prednisolone prior to being given budesonide/ eformoterol (400/12µg bid), budesonide alone (400µg bid), eformoterol alone (12µg bid) or placebo for one year. The study was designed to determine whether these treatments prevented COPD exacerbations. Severe exacerbations were defined as requiring treatment with oral corticosteroids and/or antibiotics, and/or resulting in hospitalisation. The results showed that budesonide/eformoterol reduced the relative risk of having an exacerbation by almost 30% compared to eformoterol, 29% compared to placebo, and 23% compared to budesonide. "Exacerbations can have a huge impact on patients, both physically and psychologically. For patients with moderate to severe COPD, preventing exacerbations should be one of the key goals of treatment," said Prof. Calverley. "These data show that combining budesonide and formoterol significantly reduces the risk of exacerbations." In a second randomized, double-blind, active-controlled study2, 812 patients with moderate to severe COPD were given the same treatment regimens as in the study above, but without prior optimisation of their condition with eformoterol and prednisolone. Study results again showed that budesonide/eformoterol reduced the number of severe exacerbations requiring medical intervention by 24% compared to placebo, again demonstrating the consistency of the combination's efficacy. The second study2 showed that budesonide/eformoterol improved both morning PEF and evening PEF more than budesonide or eformoterol alone. Combined budesonide/eformoterol currently has no licence in COPD. However, based on the benefits demonstrated by the budesonide/eformoterol combination over mono-components in the moderate-severe category of COPD patients, AZ has submitted a regulatory package in the EU. References: 1. Calverley PMA. Effect of budesonide/formoterol on severe exacerbations and lung function in moderate to severe COPD. Abstract to be presented at British Thoracic Society Winter Meeting, London, 4 December 2002. 2. Campbell LM, Szafranski W. Budesonide/formoterol in a single inhaler (Symbicort®) reduces severe exacerbations in patients with moderate to severe COPD. Abstract to be presented at British Thoracic Society Winter Meeting, London, 4 December 2002. 3. Symbicort 100/6 Turbohaler SmPC SOURCE: Munro and Forster Communications E-mail this page to a friend or colleague! To print, use this version