Symbicort(reg) Single Inhaler Therapy (Symbicort(reg) SiT) Demonstrates Superior Asthma Control Using Only One Inhaler

Main Category: Respiratory / Asthma
Article Date: 22 Mar 2004 - 0:00 PDT

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LUND, Sweden, Monday March 22 2004: AstraZeneca has revealed for the first time data on its new asthma treatment concept SYMBICORT(reg) (budesonide/formoterol) Single inhaler Therapy (SYMBICORT(reg) SiT).

The data shows that providing both maintenance and reliever medication in one single inhaler leads to better asthma control compared to traditional asthma treatment with a higher fixed daily dose of an inhaler containing corticosteroid and a separate rescue inhaler [1,2].

This new dosing regimen is currently under review by the European Mutual Recognition Procedure as an addition to the currently approved dosing regimen for SYMBICORT(reg), where a separate reliever medication is still required.

Once approved, SYMBICORT(reg) SiT has the potential to revolutionise the way asthma is managed by making asthma treatment more effective and simpler for both the physician and the patient.

The possibility of using the same treatment both for maintenance and as-needed relief provides a simple one-inhaler approach to asthma management. While short-acting bronchodilators provide symptom relief, they have limited effect on asthma control.

With the SYMBICORT(reg) SiT approach, short-acting bronchodilators are replaced by effective, rapid- and long-acting relief medication plus anti-inflammatory therapy.

This single-inhaler approach provides both sustained maintenance therapy and additional as-needed dose adjustments at first sign of symptoms to prevent any breakthrough symptoms developing into an attack.

The data derived from two studies was presented at the American Academy of Allergy Asthma and Immunology (AAAAI) annual conference in San Francisco, USA, on March 21, 2004.

The first, a six-month study known as STEAM, involved 697 mild to moderate asthma patients and demonstrated that asthma therapy with SYMBICORT(reg) SiT reduced the number of severe exacerbations by 54% in contrast to higher doses of a separate inhaled corticosteroid and a rescue inhaler.[1] The number of hospitalisations and emergency room visits were ten-fold lower and days with oral steroids were significantly reduced by 77% with SYMBICORT(reg) SiT.[1]

The second, a twelve-month study known as STEP, involved 1,890 moderate to severe asthma patients and demonstrated that SYMBICORT(reg) SiT significantly reduced the risk of severe exacerbations by 39% compared with an even higher fixed dose of inhaled corticosteroid and a separate rescue inhaler[2]. Those patients using SYMBICORT(reg) SiT also took significantly less inhalations of rescue medication compared with those on fixed dosing of inhaled corticosteroid and separate rescue, which is a clear sign of day-to-day improvements in asthma control. [2]

Professor Klaus Rabe, Leiden university, the Netherlands stated: "These new data are extremely encouraging. SYMBICORT(reg) SiT has been shown to offer patients effective asthma control via a treatment concept that is very simple to instruct and follow.

"Asthma is a variable disease, where patients experience periods of good control, but also periods of worsening, which can develop into acute events. The SYMBICORT(reg) Single inhaler Therapy treatment concept, when approved, will provide one single inhaler for all situations; for regular maintenance therapy, as well as for acute situations. This novel approach may have important implications for the way we manage asthma in the future."

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 top five pharmaceutical companies in the world with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.

Notes to Editors

SYMBICORT(reg) contains the inhaled corticosteroid budesonide and rapid- and long-acting beta-agonist formoterol

SYMBICORT(reg) is the only combination treatment for asthma that allows the dose of both components to be adjusted according to disease variation, without the need to switch or add inhalers

SYMBICORT(reg) is indicated for the treatment of asthma and severe COPD

Asthma treatment with SYMBICORT(reg) Single inhaler Therapy is outside the current Symbicort label in the European Union. An EU regulatory application was filed in December 2003

Asthma is a chronic inflammatory condition of the airways characterised by reversible airway obstruction. It is a variable condition that can change both daily and seasonally

References

1. KF Rabe, E Pizzichini, B Stallberg, S Romero, A Balanzat, T Soerensen, T Atienza . Single Inhaler Therapy With Budesonide/Formoterol Provides Superior Asthma Control Compared With Fixed Dosing With Budesonide Plus Terbutaline As Needed. Abstract presented at the American Academy of Allergy, Asthma and Immunology (AAAAI), San Francisco, March 21, 2004.

2. R Scicchitano, R Aalbers, D Ukena, A Manjra, L Fouquert, S Centanni, L-P Boulet. Adjustable Single Inhaler Therapy With Budesonide/Formoterol Reduces the Risk of Severe Exacerbations Compared With Budesonide Plus Terbutaline As Needed in Patients With Asthma. Abstract presented at the American Academy of Allergy, Asthma and Immunology (AAAAI), San Francisco, March 21, 2004.