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Mild Asthma, a Revolutionary Therapy from Italian Research

Published by the New England Journal of Medicine the B.E.S.T study conducted in Italy

“TAKEN ONLY WHEN NEEDED AND THE DISEASE CAN BE CONTROLLED SUCCESSFULLY”

Prof. Fabbri: “Daily drug useless for mild persistent types affecting over one million 200 thousand people”. Chiesi’s commitment to pneumological research

MILAN, Italy, 29th May 2007 – Farewell to the daily dose of cortisone necessary for the control of mild persistent asthma: an Italian study has demonstrated that successful management of the disease is possible in the early stages without the need for daily maintenance therapy. A new “when needed” approach that may significantly improve the quality of life for one million 200 thousand Italians suffering from this disease. Amongst these sufferers there are also those suffering from allergic asthma, which is very common particularly at this time of year.

These are the results of a clinical study on BEST (BEclomethasone plus Salbutamol Treatment), published by the New England Journal of Medicine, one of the most prestigious international medical publications, sponsored by Chiesi Farmaceutici and the most important pneumological centres in Italy. “This is a revolutionary study – says research coordinator, Professor Leonardo Fabbri, Head of the Clinic for Respiratory Tract Diseases at the University of Modena and Reggio Emilia – as it questions a pivotal issue within the therapeutic programme for asthma in this group of patients. Our research has demonstrated that basic inhalant therapy with a preconstituted combination of a bronchodilator (salbutamol) and cortisone (beclometasone dipropionate), taken when symptoms first appear, allows clinical control similar to that provided by continuous daily inhalant therapy with cortisone plus bronchodilator when required, as recommended by current guidelines. Clinical research in Italy gains important international recogni tion through publication in the New England Medical Journal”.

BEST is a multi-centre study (involving 8 Italian and 14 European centres), which enrolled 500 patients, monitored for 6 months. “Only sufferers who are considered mild persistent asthmatics according to current criteria were selected – explains Professor Alberto Papi, Head of the Clinic for respiratory tract illness at the University of Ferrara and assistant co-ordinator of the study. 60% of those involved in the study were suffering from allergic asthma. These are individuals who are well for most of the time, and for whom it is extremely difficult to guarantee that continuous therapy is followed as set out by current guidelines”.

“For nearly thirty years, the Chiesi Group has continuously developed the combination therapy involving bronchodilators and corticosteroids – comments Dr. Paolo Chiesi, Vice President and Head of the Italian company’s Research and Development division – Over time this initial perception has become an increasingly evident rationale and has gained significance in important clinical trials, such as the BEST study”.

“On the basis of our daily experience, – explains Dr. Germano Bettoncelli, Director of the respiratory area for the Società Italiana di Medicina Generale (Italian Society for General Medicine) – we can confirm that, when symptoms develop, most of the patients affected by this form of asthma tend to use the bronchodilator alone when required, or resort to a “DIY” drug combination, behaviour which to date has been tolerated even if it is “unorthodox”. We are therefore most certainly interested in the fact that data in support of treatment to be used when required is now emerging with the preconstituted combination of the two drugs, as this is a less burdensome and demanding therapeutic strategy&rd quo;.

Of course, but what about the patient? “It is still very difficult to get across the concept that mild persistent asthma is a chronic disease, particularly in the early stages, when the person only experiences symptoms from time to time – says Dr. Filippo Tesi, President of Federasma, the Italian Asthma Patients’ Association . The management of asthma is however closely related to the patient’s quality of life. If the disease is not correctly managed, symptoms and attacks occur much more frequently. Some of the reasons why patients fail to stick to therapy include the complex nature and the frequency of the treatment, the administration of a number of drugs several times a day, the fear of side effects, even in the long-term, and a lack of faith in the drugs. One approach that does however allow the disease to be managed more simply, would also appear to be an excellent solution for encouraging patients to stick to the treatment”.

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