Budesonide/Formoterol Maintenance And Reliever Therapy Reduces Asthma Exacerbations

Main Category: Respiratory / Asthma
Also Included In: Clinical Trials / Drug Trials
Article Date: 09 Sep 2006 - 20:00 PDT

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New data published today at the European Respiratory Society (ERS) Congress show that a new treatment approach for asthma, budesonide/formoterol Maintenance And Reliever Therapy (Symbicort SMART™), is more effective than fixed doses of either budesonide/formoterol or salmeterol/fluticasone (Seretide™) plus reliever medication in reducing all forms of exacerbations.(1)

COMPASS was a double-blind study conducted over a six-month period in 3,335 patients, which makes it the largest study of its type. COMPASS was designed to compare the efficacy and safety of budesonide/formoterol administered as both maintenance and reliever therapy, with double the usual maintenance dose of budesonide/formoterol plus a separate reliever medication and salmeterol/fluticasone at its most frequently prescribed fixed dose plus a separate reliever medication. These results confirm the findings from previous studies,(2-5) including those from the COSMOS dose titration study,2-5 showing budesonide/formoterol Maintenance And Reliever Therapy is a more effective treatment than higher maintenance doses of either budesonide/formoterol or salmeterol/fluticasone plus separate reliever medication in preventing asthma exacerbations.

Budesonide/formoterol is a combination of budesonide, an inhaled corticosteroid providing anti-inflammatory effect, and formoterol, a unique rapid and long-acting bronchodilator, which is delivered in one inhaler. With budesonide/formoterol Maintenance And Reliever Therapy, patients receive these two components as a maintenance dose in line with normal practice to establish asthma control, and take additional inhalations 'as-needed' if symptoms occur, to provide both rapid relief and increased asthma control. This means that the underlying inflammation is treated with every inhalation, even when budesonide/formoterol is used for symptom relief, which leads to a reduced risk of having an asthma attack.

Importantly, COMPASS identified no overall increase in inhaled corticosteroid use with budesonide/formoterol Maintenance And Reliever Therapy compared to both comparator groups.

In COMPASS, patients were randomised into three treatment groups. One group received salmeterol/fluticasone 25/125 ug two inhalations bd plus terbutaline as reliever, the second group received budesonide/formoterol 320/9 ug one inhalation bd plus terbutaline as reliever and the third group received budesonide/formoterol 160/4.5 ug one inhalation bd plus budesonide/formoterol as reliever (budesonide/formoterol Maintenance And Reliever Therapy treatment approach).

These new data show that for patients with poor control on moderate doses of inhaled steroid, by receiving budesonide/formoterol Maintenance And Reliever Therapy for maintenance and symptom relief, they could obtain a 39% reduction in the number of exacerbations (p<0.01) vs. fixed dose salmeterol/fluticasone and a 28% reduction vs. fixed dose budesonide/formoterol (p<0.01).

Patients taking budesonide/formoterol 160/4.5 ug Maintenance And Reliever Therapy used at least 25% less inhaled corticosteroid (beclamethasone equivalent) than patients on fixed dose budesonide/formoterol 320/9 ug, or fixed dose salmeterol/fluticasone 25/125 ug. All treatments provided similar improvements in the indicators of day to day asthma control and were well tolerated.

Professor Piotr Kuna, Department of Pneumonology and Allergy, Barlicki University Hospital, Poland, and lead investigator of COMPASS, commented, 'COMPASS was an important study to undertake as the reduction of exacerbations really is one the most fundamental goals of asthma management. By reducing the number of exacerbations, we can greatly reduce the impact of asthma on a huge number of people affected by this extremely common, yet underestimated disease as well as the considerable pressure that the treatment of exacerbations places upon healthcare systems', he concluded.

A large patient study(6) that was recently published highlights that many people with asthma are poorly controlled. The study found that despite being prescribed regular medication, only 28% of patients were well controlled, and 84% of patients experienced periods of worsenings within the last year (mean 11/year). On average 27% of the worsenings that they had experienced in the last year were severe.

Today's results build upon the earlier results for budesonide/formoterol Maintenance And Reliever Therapy from the COSMOS study(2). COSMOS was an open label trial providing clinicians with the freedom to be able to titrate the dose, according to clinical judgement, as they do in the real world, for example, when control was considered inadequate due to the variable nature of asthma. This design also allowed the patients to use only one inhaler for both maintenance and relief. COMPASS, being a double-blind study, now shows that budesonide/formoterol Maintenance And Reliever Therapy is a more effective treatment than a higher maintenance dose of either budesonide/formoterol or salmeterol/fluticasone combination plus reliever medication.

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Article adapted by Medical News Today from original press release.
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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 world's leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the DowJones Sustainability Index (Global) as well as the FTSE4Good Index.

For further updates, news and information on budesonide/formoterol, please visit http://www.astrazenecapressoffice.com

References
1. Kuna P, Peters MJ, Buhl R. Budesonide/formoterol as maintenance and reliever therapy reduces asthma exacerbations versus a higher maintenance dose of budesonide/formoterol or salmeterol/fluticasone. Abstract presented at the ERS Congress 2006.

2. Vogelmeier C, D'Urzo A, Pauwels R, Merino JM, Jaspal M, Boutet S, Naya I, Price D. Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option? Eur Respir J 2005; 26(5): 819-828.

3. O'Byrne P, Bisgaard H, Godard P, Pistolesi M, Palmqvist M, Zhu Y, Ekstrom T, Bateman E. Budesonide/Formoterol Combination Therapy as Both Maintenance and Reliever Medication in Asthma. American Journal of Respiratory and Critical Care Medicine 2005; 171(2): 129-136.

4. Scicchitano R, Aalbers R, Ukena D, Manjra A, Fouquert L, Centanni S, Boulet L-P, Naya IP, Hultquist C. Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. Current Medical Research and Opinion 2004;20(9):1403-18.

5. Rabe KF, Emilio Pizzichini, Bjorn Stollberg, Santiago Romero, Ana M. Balanzat, Tito Atienza, Per Arve Lier, and Carin Jorup, Budesonide/Formoterol in a Single Inhaler for Maintenance and Relief in Mild-to-Moderate Asthma: A Randomized, Double-Blind Trial, Chest, Feb 2006; 129: 246 - 256.

6. Partridge M, BMC Pulmonary Medicine: http://www.biomedcentral.com/bmcpulmmed/ , BMC Pulmonary Medicine 2006;6:13

COMPASS and SMILE are part of an extensive clinical study programme for budesonide/formoterol Maintenance And Reliever Therapy, so far involving over 17,000 patients of all asthma severity and age ranges. AstraZeneca is continuing to investigate what we think is the most efficacious and simple way of managing asthma in the future.

About COMPASS
- COMPASS compared the use of budesonide/formoterol when used as both Maintenance And Reliever Therapy with the use of a higher maintenance dose of budesonide/formoterol or salmeterol/fluticasone plus terbutaline reliever use
- COMPASS was a six-month, randomised, double-blind study of symptomatic patients with asthma
- Patients with asthma who were symptomatic on their current inhaled corticosteroid treatments were randomised to a combination maintenance therapy and in two out of three cases, a separate reliever medication
- The budesonide/formoterol Maintenance And Reliever Therapy group received budesonide/formoterol 160/4.5 ug bid plus additional doses of budesonide/formoterol 160/4.5 ug as-needed
- The first comparator group received a higher but fixed dose of the combination therapy, budesonide / formoterol 320/9 ug bid plus a separate SABA (terbutaline) as-needed
- The second comparator group received a fixed dose of salmeterol/fluticasone 50/250 ug bid, its most prescribed dose, plus a SABA (terbutaline) as-needed
- The different groups were monitored to access time to first severe exacerbation and the rate of severe exacerbations
- Additional end points were: hospitalisations, night time awakenings, symptoms, use of rescue medication and lung function

About COSMOS
- This was a 12-month, randomised, open-label, parallel group, dose-titration study conducted in a real-life setting (clinicians were free to vary medication levels according to their clinical judgement)
- Patients with persistent asthma were randomised to either budesonide/formoterol Maintenance And Reliever Therapy 160/4.5 ug 2 inhalations bid as maintenance with additional inhalations as needed for symptom relief, or fixed dose salmeterol/fluticasone 50/250 ug bid as maintenance plus salbutamol as rescue medication. After 4 weeks of treatment and onwards titration of the maintenance doses was allowed
- Budesonide/formoterol Maintenance And Reliever Therapy was administered via Turbuhaler™ and salmeterol/fluticasone plus salbutamol was administered via dry-powder inhaler
- Results showed that budesonide/formoterol Maintenance And Reliever Therapy provided superior asthma control compared with fixed dose salmeterol/fluticasone, resulting in significantly lower severe exacerbation risk (25 percent), less use of rescue medication (38 percent), and fewer emergency room visits (16 percent)
- COSMOS was published in European Respiratory Journal : Vogelmeier C, D'Urzo A, Pauwels R, Merino JM, Jaspal M, Boutet S, Naya I, Price D. Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option? Eur Respir J 2005; 26(5): 819-828

Budesonide/formoterol in General
- Budesonide/formoterol is currently approved in more than 90 countries; sales were $585 million in the first half 2006 (up 17 percent on 2005 figures) and have now reached more than five million treatment years. Budesonide/formoterol Maintenance And Reliever Therapy is previously approved in Australia, Argentina, Brazil, Mexico, the Philippines, Switzerland and Thailand
- Budesonide/formoterol Maintenance And Reliever Therapy is currently under review elsewhere, including the European Union
- Budesonide/formoterol received FDA approval in the US in July 2006 for maintenance treatment of asthma