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6 December 2002
NEW DATA DEMONSTRATES SYMBICORT® IS AN EFFECTIVE NEW TREATMENT FOR MODERATE TO SEVERE COPD

AstraZeneca announced today that new data from a 12 month study presented at the British Thoracic Society (BTS) show that SYMBICORT® TURBUHALER® markedly reduces exacerbations and improves lung function in patients with moderate to severe chronic obstructive pulmonary disease (COPD), making it an important new treatment for this serious disease.

“Millions of asthma patients have already experienced the rapid and sustained control that SYMBICORT can offer; these new data clearly show that patients suffering from COPD, a progressive and devastating disease, would also benefit from taking SYMBICORT , “ said Anders Ekblom, Vice President, Respiratory Therapy Area, AstraZeneca. “These data, alongside the promising results presented earlier this year, show consistently that SYMBICORT is effective in COPD and that this effect is significantly separated from that of either of the pharmacological components. The data provide robust support to the application to extend the label for SYMBICORT to cover treatment for COPD, which was submitted to regulatory authorities this year.”

The results of this large study showed that SYMBICORT was clearly superior to either inhaled corticosteroids or long acting beta-agonists given as monotherapy. Thus SYMBICORT reduced the risk of having an exacerbation requiring medical intervention by 30 per cent compared to formoterol, 29 per cent compared to placebo, and 23 per cent compared to budesonide. SYMBICORT treatment also led to a rapid and sustained improvement in lung function. Post-dose FEV (a measure of lung function) was 11 per cent higher after taking SYMBICORT than after taking budesonide alone, and 5 per cent higher than after only formoterol alone.

These data support results from a previous one-year study in COPD presented earlier this year at the Annual Congress of the European Respiratory Society (ERS), which showed that SYMBICORT significantly reduced the number of exacerbations requiring medical intervention and improved lung function in patients, as well as provided rapid and sustained relief from COPD symptoms. “This is the first time that two independent studies with the same product have shown such consistent benefits in this difficult to treat patient population and they provide a strong rationale for the use of SYMBICORT in COPD” said Anders Ekblom.

SYMBICORT TURBUHALER, a dry powder inhaler that contains the corticosteroid budesonide and the rapid-acting, long-lasting bronchodilator formoterol, is already successfully used for the treatment of asthma in adults and adolescents.

Launched only last year, SYMBICORT recorded sales of $122 million in the first half of 2002. SYMBICORT has already captured approximately 20 per cent of the market share in sixteen launch markets in Europe. Phase III studies are underway to support the registration in the United States of the product for asthma (in a pressurised metered dose inhaler). AstraZeneca has submitted a regulatory package in the EU and other countries outside the US seeking approval for SYMBICORT in COPD. The COPD market is currently worth $2.9 billion, and is anticipated to amount more than $9 billion in 2010.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $16.4 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products.

Further enquires to:

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+44 (0)20 7304 5033

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+44 (0)20 7304 5087


Note to News Editors:

  • In the study presented today, 1022 patients with moderate to severe COPD and a history of exacerbations had their condition stabilised with formoterol and oral prednisolone (a corticosteroid) prior to being given SYMBICORT (budesonide/formoterol--320/9µg bid), budesonide only (400µg bid), formoterol only (9µg bid), or placebo for one year. This study was designed to determine whether these treatments prevented COPD exacerbations necessitating the use of oral corticosteroids or antibiotics, or hospitalisation.
  • COPD is a progressive and disabling disease characterised by airflow obstruction that is not fully reversible, and by symptoms such as dyspnoea, breathlessness, cough, and sputum hypersecretion. It is estimated that more than 600 Million people suffer from COPD, which is the fourth leading cause of death in the industrialised world. COPD exerts a heavy burden on patients, their carers, healthcare resources and society.
  • Budesonide/formoterol in a single inhaler is sold by AstraZeneca as Symbicort® Turbuhaler®. Budesonide is sold under the trade name Pulmicort®, and formoterol as Oxis®, both are also sold by AstraZeneca.


SYMBICORT  is a trademark, property of the AstraZeneca group of companies.

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