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Title: Symbicort Turbohaler (Budesonide/Eformoterol) Provides Rapid, Effective Asthma Control: Presented at ERS

"Symbicort Turbohaler (Budesonide/Eformoterol) Provides Rapid, Effective Asthma Control: Presented at ERS"

BERLIN, GERMANY -- September 24, 2001 -- New data presented at the 11th Annual Congress of the European Respiratory Society (ERS) in Berlin, has shown that the new single inhaler maintenance asthma therapy Symbicortâ Turbohalerâ(budesonide/eformoterol) gains significantly better asthma control than budesonide(1-4) alone. Further studies have also shown that budesonide/eformoterol Turbohaler gains control significantly more effectively and more rapidly compared to high dose fluticasone(5,6). Beyond the improved convenience from having two effective treatments in a single inhaler, the fact that this combination treatment gains bronchodilatory control rapidly (one-three minutes) may provide patients with greater confidence in their treatment and thus help to reinforce good adherence to their asthma therapy. According to the lead investigator of three new studies, Prof. Roland Buhl of the Mainz University Hospital, Mainz, Germany, this combination treatment is a significant new development in the field of asthma management. "Having budesonide and eformoterol in the same inhaler to simultaneously treat underlying inflammation and bronchoconstriction is enabling doctors to quickly and effectively gain and maintain control of their patient's condition. This will be key in terms of their long-term prognosis," he explained. "Symbicort Turbohaler will benefit not only those adult asthma patients inadequately controlled on inhaled corticosteroid therapy and who need a long-acting bronchodilator, but also those patients who are already taking these two treatments as separate inhalers," Dr. Buhl added. Recent studies sponsored by AstraZeneca, including one United Kingdom and one pan-European asthma patient survey, have all shown a consistently high level of uncontrolled asthma in the community(7-10). Because a significant number of asthma patients are not adhering to their prescribed preventer medication(7,8), they are not receiving the optimum treatment to match their disease. As a result, these patients experience unnecessary symptoms of poor control of their asthma in the form of coughing, wheezing, waking at night and exercise restrictions. In severe cases, this lack of control can lead to an emergency visit to a healthcare professional, or admission to hospital. One study of 362 patients measured control of asthma in terms of a Total Asthma Control Week (TACW), defined as a week with no symptoms, no awakenings and reliever uses Ł four inhalations/week for Ł two days. Compared with budesonide 400ľg bd alone, Symbicort Turbohaler 200/6ľg bd increased the chance of achieving a TACW in adults with moderate persistent asthma by 78 percent in weeks one-four (p<0.05), and by 90 percent in weeks one-12 (p<0.05)(1). In another trial of 344 patients, Symbicort Turbohaler 200/6ľg bd, as maintenance therapy, was shown to gain control significantly more effectively and rapidly in adults with moderate persistent asthma compared to high dose fluticasone disk inhaler 250ľg bd alone, with the benefits sustained throughout a 12-week treatment period(5,6). The study examined the risk of exacerbations evaluated as the chance of achieving a Well Controlled Asthma Week (WCAW), defined as a week with no awakenings and reliever use Ł four inhalations/week for Ł two days and allowing symptoms on two days/week(5). In this study the risk of a mild exacerbation was significantly lower in the combination treatment group than the fluticasone group, and the incidence of severe exacerbations was also lower in the combination treated patients(5), as were the chances of achieving a WCAW which were increased by 46 percent (odds ratio: 1.46 95 percent CI; 1.03, 2.07)(5). "Any treatment that helps doctors to encourage patients to be more in control of their asthma is a welcome advance," said Professor Bateman of the University of Cape Town, in Cape Town, South Africa, and lead investigator of two new studies. "Because Symbicort Turbohaler is a maintenance therapy that gains control quickly, it should provide patients with greater confidence in their treatment and thus help to reinforce good adherence to their asthma therapy," he concluded. In two of the studies(2,11), once-daily treatment with Symbicort Turbohaler 200/6ľg two inhalations has been shown to improve and maintain asthma control at least as effectively as the equivalent total daily dose of the combination treatment, administered twice-daily in the morning and evening. In addition, once-daily treatment with the combination proved to be significantly more effective than a corresponding once-daily dose of budesonide(3,11). "For patients who are well controlled on one inhalation twice daily, Symbicort Turbohaler provides the option to take the total daily dose as two inhalations once a day. This is an important benefit as it may be more convenient for patients and lead to improved adherence to treatment," explained Dr. Buhl. Another study, using low-dose Symbicort Turbohaler 100/6ľg, showed that a once-daily regimen of two inhalations is equivalent in efficacy to one inhalation twice-daily dosing in the maintenance treatment of adults with stable mild-to-moderate persistent asthma, and significantly more effective than the corresponding dose of budesonide alone(3). References 1. Buhl R, Zetterström O, Mellem H, et al. Improved asthma control with budesonide/ formoterol via a single inhaler, compared with budesonide alone, in moderate persistent asthma. Abstract presented at European Respiratory Society Conference, Berlin, 22-26 September 2001 2. Buhl R, Creemers JPHM, Vondra V, et al. Improved and maintained asthma control with once-daily budesonide/ formoterol single inhaler therapy in mild-to-moderate persistent asthma. Abstract presented at European Respiratory Society Conference, Berlin, 22-26 September 2001 3. Kuna P, Chuchalin A, Ringdal N, et al, Low-dose single-inhaler budesonide/ formoterol administered once daily is effective in mild-persistent asthma. Abstract presented at European Respiratory Society Conference, Berlin, 22-26 September 2001 4. Lalloo UG, Malolespszy J, Kozma D, et al. Budesonide and formoterol in a single inhaler is more effective than a higher dose of inhaled corticosteroid in mild-moderate persistent asthma. Abstract presented at European Respiratory Society Conference, Berlin, 22-26 September 2001 5. Bateman ED, Bantje TA, Joao Gomes M, et al. Budesonide/ formoterol in a single inhaler improves asthma control more effectively than a higher dose of fluticasone. Abstract presented at European Respiratory Society Conference, Berlin, 22-26 September 2001 6. Bateman ED, Bantje TA, Joao Gomes M, et al. Early and sustained benefits of budesonide and formoterol in a single inhaler vs fluticasone in moderate asthma. Abstract presented at European Respiratory Society Conference, Berlin, 22-26 September 2001 7. Living & Breathing Steering Committee. Putting Patients First in Asthma. Key findings and analysis of a nationwide survey of asthma patients, May 2001 8. RESPONSE (Respiratory Patient Opinion Survey) AstraZeneca, 2001 9. Strachan DP. Defining unmet need: relationship between asthma symptoms, asthma-related disability and level of treatment in a nationwide interview survey. Asthma J 2000; 5: 137-140 10. Rabe KF, Vermeire PA, Soriano JB, Maier WC. Clinical management of asthma in 1999: the Asthma Insights and Reality in Europe (AIRE) study. Eur Respir J 2000; 6: 802-807 11. Buhl R, Creemers JPHM, Vondra V, et al. Once-daily budesonide/ formoterol via a single inhaler is effective in mild-to-moderate persistent asthma. Abstract presented at European Respiratory Society Conference, Berlin, 22-26 September 2001 SOURCE: AstraZeneca

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