May 23 2005
A new asthma treatment regimen promises to deliver a great improvement in key measures of asthma control and should simplify the management of the disease compared with other treatments.
Symbicort, which is produced by AstraZeneca is meant to be an alternative to SeretideTM and has been shown in trials to reduce the risk of a severe asthma attack by 25 per cent, and the total number of severe asthma attacks by 22 per cent, when compared to Seretide.
The Cosmos trial is the first ‘real-life,’ head-to-head trial of the two most commonly used combination treatments, which studied 2,143 patients with moderate to severe asthma in 16 countries.
The study was 'open label' to allow for doctors choice in treatment, and compared Symbicort Single Inhaler Therapy with a titrated dose of Seretide.
The trial 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 study showed that patients using the Symbicort 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 study, more Symbicort 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 requires the use of separate maintenance and reliever inhalers.
In contrast, Symbicort 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 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. The Symbicort therapy offered a more effective treatment option than Seretide, and as it demands fewer inhalers, it is simpler for patients to use.
There were additional benefits observed in the trial.
A 34 per cent reduction in oral steroid days and a 37 per cent reduction in hospital days was noted, and there was significantly less need for rescue medication throughout the year.
Much higher maximum lung function (FEV1) following bronchodilation at the clinic was observed and 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.
The COSMOS trial is part of a wider clinical trial programme that has already shown the 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 new treatment prevents patients from developing potentially life-threatening asthma attacks significantly better than fixed dosing.
In November 2004, AstraZeneca announced its plans to add the results from the Cosmos study to its European regulatory file for Symbicort Inhaler Therapy, with re-submission planned before end of 2005. Symbicort is currently approved in more than 90 countries.
The results from the Cosmos trial, were presented at the 101st International Conference of the American Thoracic Society (ATS), San Diego.
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