Symbicort Maintenance and Reliever Therapy is Highly Effective Compared with Any Dose of Seretide

Main Category: Respiratory / Asthma
Article Date: 20 Nov 2005 - 14:00 PDT

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New clinical trial data, published today in the European Respiratory Journal (ERJ)1, reveals that AstraZeneca's novel treatment concept - SYMBICORT(R) Maintenance And Reliever Therapy(TM) - is highly effective compared with SeretideTM (fluticasone/ salmeterol). The study also provides further evidence that a treatment regimen using just one inhaler for patients day-to-day needs, maintenance and relief, is at least as effective in a real world setting to multiple inhaler therapy with Seretide plus Ventolin. The study was performed over a one-year period during which clinicians could increase or decrease patients' maintenance therapy to maintain asthma control.

Results from the COSMOS dose titration trial - first presented this year at both the International Congress of the American Thoracic Society (ATS) and the Annual Congress of the European Respiratory Society (ERS) - demonstrate that treating patients with SYMBICORT (budesonide/ formoterol) Maintenance And Reliever Therapy reduced the risk of a first severe asthma attack by 25 per cent (p=0.0076). The study also showed a significant reduction in the total number of severe asthma attacks among patients taking SYMBICORT, 255 versus 329 in the Seretide group (primary endpoint). Furthermore, this improved control was attained using 38 per cent less reliever medication in comparison to patients treated with Seretide (0.58 vs. 0.93 inhalations/day; p<0.001). Despite doctors having the option to decrease maintenance therapy in both groups or increase maintenance therapy only in the Seretide group, throughout the 12-month study period, increases in lung function and decreases in symptoms and reliever usage were always in favour of SYMBICORT Maintenance And Reliever Therapy. Indeed after one year, more patients were well-controlled, based on needing a maximum of four inhalations of as-needed medication per week with SYMBICORT than with Seretide (76 per cent versus 66 per cent, p<0.001).

Professor Claus Vogelmeier, lead author of the COSMOS study commented: "The COSMOS study was designed to evaluate the concept of SYMBICORT Maintenance And Reliever Therapy in a study setting that mimics clinical practice. We found that by using this strategy, several parameters reflecting asthma control can be markedly improved to a level that is comparable with other existing combination therapies. However, SYMBICORT Maintenance And Reliever Therapy induced a significant reduction of the frequency of severe asthma exacerbations. It is these attacks that patients fear and cause greatest demands on the healthcare system".

COSMOS, is the first 'real-life', one year, head-to-head trial comparing SYMBICORT Maintenance And Reliever Therapy with a titrated dose of Seretide, used according to its label (100/50, 250/50 and/or 500/50 BID). The trial included 2,143 patients with moderate to severe asthma in 16 countries and was conducted open label to mirror routine clinical practice as much as possible, allowing physicians to judge the appropriate maintenance dose of both SYMBICORT and Seretide respectively.

Combining maintenance and reliever medication into one inhaler is only possible with SYMBICORT as it contains formoterol, a rapid-acting and long lasting bronchodilator, and thus not with Seretide.

COSMOS is part of the wider, ongoing SYMBICORT Maintenance And Reliever Therapy clinical trials programme, including over 14,000 patients with mild to severe asthma. The results of all studies published to date1,2,3,4,5 consistently indicate that SYMBICORT Maintenance And Reliever Therapy prevents patients from developing potentially life-threatening asthma attacks significantly better than fixed dose ICS or combination therapy. SYMBICORT Maintenance And Reliever Therapy is currently approved in four markets outside the European Union. The regulatory process for the European Union started in October 2005.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For more information, please visit www.astrazenecapressoffice.com

References

1. Vogelmeier C, D'Urzo A, Pauwels R, Merino JM, Jaspal M, Boutet S, Naya I, Price D. Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option? Eur Respir J 2005; 26(5): 819-828.

2. KF Rabe, E Pizzichini, B Stollberg et al. Single Inhaler Therapy With Budesonide/Formoterol Provides Superior Asthma Control Compared With Fixed Dosing With Budesonide Plus Terbutaline As Needed. Abstract presented at the 60th International Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI), San Francisco, USA, March, 2004. Currently in press.

3. Scicchitano R, Aalbers R, Ukena D, Manjra A, Fouquert L, Centanni S, Boulet L-P, Naya IP, Hultquist C. Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. Current Medical Research and Opinion 2004;20(9):1403-18.

4. D'Urzo A, Vogelmeier C, Jaspal M, Merino JM, Boutet S. Symbicort (Budesonide/Formoterol) for Both Maintenance and Relief Reduces the Exacerbation Burden Compared with a Titration of Seretide (Salmeterol/Fluticasone) in Patients with Asthma: A Real-life Study. Abstract presented at the ATS Congress 2005. Currently in press.

5. O'Byrne P, Bisgaard H, Godard P, Pistolesi M, Palmqvist M, Zhu Y, Ekstrom T, Bateman E. Budesonide/Formoterol Combination Therapy as Both Maintenance and Reliever Medication in Asthma. American Journal of Respiratory and Critical Care Medicine 2005; 171(2): 129-136.