Results of the OPTIMA study show significant benefits from early and sustained treatment of mild asthma

November 12, 2001

Earlier and more sustained treatment of mild asthma improves control of asthma symptoms and reduces the risk of a severe exacerbation, thereby preventing lung function damage according to the results of the OPTIMA (Oxis and Pulmicort Turbuhaler In the Management of Asthma) study, published today in the American Journal of Respiratory and Critical Care Medicine.1

The year-long primary care study showed for the first time that in mild asthma patients, who were not previously treated with inhaled corticosteroids, a low dose of the inhaled corticosteroid, Pulmicort® (budesonide) reduced the rate of severe exacerbations and poorly controlled asthma days by half. In patients already taking low-dose inhaled corticosteroids, but still experiencing asthma symptoms, the addition of the fast-onset, long-acting beta-agonist, Oxis® (formoterol), was more effective than doubling the dose of budesonide in improving symptom control and reducing severe exacerbations.1

The FACET (Formoterol And Corticosteroids [budesonide] Establishing Therapy) study, has already demonstrated that the combined use of formoterol and budesonide helps the moderate to severe asthma patient to control their symptoms by reducing exacerbations.2 OPTIMA however, is the first study to demonstrate the benefits of more aggressive use of treatment in patients with mild asthma. The combination of budesonide and formoterol, studied in both FACET and OPTIMA, makes up Symbicort®, the new asthma treatment launched in August 2000.

"OPTIMA has important implications for patients with mild asthma, many of whom are managed in primary care and receive no or sub-optimal treatment and so suffer poor symptom control1,3,4,7," said Professor Paul O'Byrne, chairman of the OPTIMA scientific advisory committee and Professor of Medicine and Head of the Division of Respiratory Medicine, McMaster University in Hamilton, Ontario, Canada. "For many of these mild asthma patients the current treatment recommendations5,6 are not being effectively implemented."

Professor Peter Barnes, Head of Thoracic Medicine at the National Heart and Lung Institute, London, UK and OPTIMA co-author, continued: "The results clearly show that better asthma control can be achieved in the previously untreated patient. On this evidence, GPs can now adopt an earlier and more sustained approach to the treatment of mild asthma. For asthma sufferers - struggling to control their symptoms and resigned to the impact of asthma on their lives3,7 - OPTIMA offers hope for an improved quality of life and also the avoidance of lung function damage and associated resistance to treatment".

The 1,970 mild asthma patients from 17 countries that took part in the OPTIMA study were randomly assigned to one of two groups. Group A comprised of 698 previously untreated (steroid-naïve) patients and received twice-daily treatments with placebo, or 100 μg budesonide, or 100 μg budesonide plus 4.5 μg formoterol. Group B comprised of 1272 corticosteroid-treated patients and were given twice-daily treatment with 100 μg budesonide, or 100 μg budesonide plus 4.5 μg formoterol, or 200 μg budesonide, or 200 μg budesonide4.5 μg formoterol.

In group A, low dose budesonide alone reduced the risk for the first severe asthma exacerbation by 60 per cent and the rate of poorly controlled asthma days by 48 per cent compared with placebo. There was also an improvement in lung function and a reduction in the rate of exacerbations, asthma symptoms, nocturnal awakening and number of rescue inhalations of short-acting inhaled beta-agonists in the budesonide group. The addition of formoterol to the budesonide treated group resulted in a small improvement in lung function but offered no further benefit to exacerbation risk or asthma control.

In Group B, doubling the dose of budesonide had little clinical effect, but adding formoterol reduced the risk for the first severe exacerbation by 43 per cent and the rate of poorly controlled asthma days by 30 per cent. In addition, lung function was improved and asthma symptoms, including the need for rescue inhalations of a short-acting inhaled beta-agonist, were reduced.

All treatments were well tolerated with class-specific adverse effects occurring in less than two per cent of patients in any treatment arm.

That there is a significant morbidity associated with mild asthma is demonstrated by the fact that one third of the patients taking placebo in Group A experienced a severe asthma exacerbation during the study period. Asthma in this group was poorly controlled on 14 per cent of the days, with frequent symptoms such as nocturnal awakening and number of rescue inhalations of a short-acting inhaled beta-agonist. These patients would normally be considered to have mild asthma and would be managed in the primary care setting, often without inhaled corticosteroids. Regular treatment with budesonide was highly effective in this group of patients.

The results from OPTIMA Group B suggest that patients, with what is perceived to be very mild asthma, would benefit from early treatment with budesonide and formoterol. In patients that do not achieve ideal asthma control on inhaled corticosteroids alone, addition of formoterol improves asthma control and reduces exacerbations. The OPTIMA treatment regimen is key to the successful management approach demonstrated in the OPTIMA study.

Extensive clinical experience supports the safety and efficacy of both budesonide and formoterol which, when given through Turbuhaler, combine good lung deposition with minimal systemic effects8 and are easy to use compared with other devices9,10,11. Formoterol provides long-lasting bronchodilation with a fast onset of action12, giving rapid relief of symptoms, whilst also benefiting from delivery via the user friendly and highly effective Turbuhaler.

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 $15.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products.
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For further information, please contact:
Maria Pierrou
AstraZeneca PS&L
Tel: +46 46 33 77 72
Fax: +46 46 33 69 99
Mobile: +46 705 37 77 72
E-mail: maria.pierrou@astrazeneca.com

Carrie Monaghan
Ketchum London
Tel: +44 20 7611 3613
Fax: +44 20 7611 3850
Mobile: +44 7764 487 460
E-mail: carrie.monaghan@ketchum.com

References:
1. O'Byrne PM, Barnes PJ, Rodriguez-Roisin R, Runnerstrom E, Sandström T, Svensson K, Tattersfield A. Low dose inhaled budesonide and formoterol in mild persistent asthma: the OPTIMA randomized trial. Am J Respir Crit Care Med, 2001; 164, Issue 8
2. Pauwels RA, Löfdahl C-G, Postma DS, Tattersfield AE, O'Byrne P, Barnes PJ, Ullman A. Effect of inhaled formoterol and budesonide on exacerbations of asthma. N Engl J Med, 1997; 337:1405-11
3. Turner-Warwick M. Nocturnal asthma: a study in general practice. J R Coll Gen Pract, 1989; 39:239-43.
4. O'Byrne PM, Cuddy L, Taylor DW, Birch S, Morris J, Syrotiuk J. The clinical efficacy and cost benefit of inhaled corticosteroids as therapy in patients with mild asthma in primary care practice. Can.Resp.J, 1996; 3:169-75.
5. Global Initiative for Asthma (GINA). Pocket guide for asthma management and prevention. Publication No. 96-3659B. National Institutes of Health, National Heart, Lung and Blood Institute. Revised November 1998.
6. The British Thoracic Society, The National Asthma Campaign, The Royal College of Physicians of London in association with the General Practitioner in Asthma Group, the British Association of Accident and Emergency Medicine, the British Paediatric Society and the Royal College of Paediatrics and Child Health. The British guidelines on asthma management: 1995 review and position statement. Thorax, 1997; 52(suppl 1): 1-21S
7. Rabe KF, Vermiere PA, Soriano, JB, Maier WC. Clinical Management of asthma in 1999: the Asthma Insights and Reality in Europe (AIRE) study. Eur Respir J, 2000; 16: 802-807
8. Pauwels R, Newman S, Borgström L. Airway deposition and airway effects of antiasthma drugs delivered from metered-dose inhalers. Eur Respir J, 1997; 10: 2127-38
9. Pederson S, O'Byrne PA. A comparison of the efficacy and safety of inhaled corticosteroids in asthma. Allergy, 1997; 52(suppl 39):1-34
10. Van Spiegel PI, Jenner F. A patient preference study comparing Turbuhaler with Diskus, two multi-dose dry powder inhaler devices. Br J Clin Research, 1997; 8: 33-45
11. Jadad AR, Sullivan C, Luo D, Allen IE, Ross SD, Sheinhait IA. Patient preferences for turbuhaler or pressurized metered dose inhalers (pMDIs) in the treatment of obstructive airway disease: A systematic review. J Allergy Clin Immunol, 2000; 105(No 1 Pt2): S17
12. Palmqvist M, Persson G, Lazer L, Rosenborg J, Larsson P, Lötvall J. Inhaled dry-powder formoterol and salmeterol in asthmatic patients: onset of action, duration of effect and potency. Eur Respir J 1997; 10:2484-2489.

Ketchum UK

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