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| 23 May 2005 | 2005-05-23T14:00:00.0000000+01:00 |
| SYMBICORT® SINGLE INHALER THERAPY™ GIVES GREATER IMPROVEMENT IN ASTHMA CONTROL AND REQUIRES LESS INHALERS COMPARED TO SERETIDE™
AstraZeneca today announced that its novel treatment regimen, SYMBICORT® Single Inhaler TherapyTM delivers greater improvement in key measures of asthma control and simplifies management of the disease when compared to SeretideTM (fluticasone/salmeterol). | Results from the COSMOS trial, presented at the 101st International Conference of the American Thoracic Society (ATS), San Diego, demonstrate that SYMBICORT Single Inhaler Therapy, (budesonide/formoterol maintenance and reliever therapy), reduces the risk of a severe asthma attack by 25 per cent (primary endpoint) and the total number of severe asthma attacks by 22 per cent, when compared to Seretide.
COSMOS is the first ‘real-life,’ head-to-head trial of the two commonly used combination treatments and studied 2,143 patients with moderate to severe asthma in 16 countries. The study was open label to allow for clinician choice in treatment, and compared SYMBICORT Single Inhaler Therapy with a titrated dose of Seretide (as judged appropriate by the treating physician: 100/50, 250/50 and/or 500/50 BID). COSMOS examined the benefits of using the same single inhaler for maintenance and relief or multiple maintenance and reliever inhalers. Throughout the one-year study, clinicians were given the freedom to adjust the maintenance dose in both treatment groups.
The COSMOS study shows that patients using SYMBICORT Single Inhaler Therapy experienced fewer severe asthma attacks and required less rescue medication compared to patients taking Seretide. Less than four inhalations of rescue medication per week indicates good asthma control and at the end of the COSMOS study, more SYMBICORT Single Inhaler Therapy patients demonstrated good control of their symptoms by using low levels of rescue therapy (76 per cent compared to 66 per cent of Seretide patients).
The traditional fixed dosing treatment approach used for Seretide in the COSMOS study requires the use of separate maintenance and reliever inhalers. In contrast, SYMBICORT Single Inhaler Therapy combines two key components of asthma therapy in one inhaler - formoterol, a unique rapid and long lasting bronchodilator, which can be used both as maintenance and reliever medication; and budesonide, an inhaled corticosteroid that provides an additional anti-inflammatory effect.
Throughout the COSMOS study, SYMBICORT Single Inhaler Therapy patients managed their asthma using the same single inhaler for both maintenance and relief. In contrast, 55 per cent of the Seretide patients required at least three different inhalers to manage their asthma (i.e. different Seretide inhaler strengths along with an additional salbutamol inhaler used as rescue medication). International asthma guidelines clearly indicate that compliance amongst patients is negatively affected by complex treatment regimens resulting in poor asthma control. SYMBICORT Single Inhaler Therapy not only offers a more effective treatment option than Seretide, but as it requires fewer inhalers, it is also simpler for patients to use.
Additional benefits observed in the COSMOS trial for patients treated within the SYMBICORT Single Inhaler Therapy group, versus the Seretide group, were as follows:
· The full effect on the exacerbation burden was exemplified by a 34 per cent reduction in oral steroid days and a 37 per cent reduction in hospital days · Significantly less need for rescue medication throughout the year (38 per cent)
· Significantly higher maximum lung function (FEV1) following bronchodilation at the clinic
· At the end of the study more patients were able to manage their asthma with a reduced dose of regular combination treatment compared to their initial maintenance dose (31 per cent with Symbicort Single Inhaler Therapy vs. 14 per cent for Seretide)
COSMOS is part of a wider clinical trial programme that has already exhibited superiority of SYMBICORT Single Inhaler Therapy versus a fixed dose treatment regimen. The programme now includes over 13,000 patients with mild to severe asthma and the results of studies consistently indicate that this novel treatment regimen prevents patients from developing potentially life-threatening asthma attacks significantly better than fixed dosing.
In November 2004, AstraZeneca announced its plans to add results from the COSMOS study to its European regulatory file for SYMBICORT Single Inhaler Therapy, with re-submission planned before end of 2005. SYMBICORT is currently approved in more than 90 countries and SYMBICORT Single Inhaler Therapy is already approved in Brazil and The Philippines.
Media Enquiries:
Steve Brown, +44 207 304 5033
Edel McCaffrey, +44 207 304 5034
Investor Enquiries:
Mina Blair, +44 207 304 5084
Jonathan Hunt, +44 207 304 5087
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.
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