By Paula Moyer
MUNICH, GERMANY -- September 6, 2006 -- A treatment for asthma using the inhaled corticosteroid (ICS) budesonide and the long-acting beta-agonist formoterol (Symbicort) can be used to relieve acute asthma symptoms as well as for its primary purpose as maintenance therapy, according to investigators speaking here at the European Respiratory Society 16th Annual Congress (ERS).
This finding will help simplify asthma management, said principal investigator Piotr Kuna, MD, chair, department of pulmonology and allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland, who presented the findings on September 3rd.
Typically, maintenance therapy for asthma involves an ICS alone or in combination with a long-acting beta-agonist, either as separate inhalers or in one device. Acute exacerbations are typically managed with a short-acting beta-agonist.
Dr. Kuna and colleagues evaluated the use of Symbicort Maintenance And Reliever Therapy (SMART) versus higher maintenance doses of combination therapy plus reliever therapy in 3,335 symptomatic patients with asthma 12 years of age or older and had an average forced expiratory volume in 1 second (FEV1) of 73%.
In the 6-month study, patients were randomized in double-blind fashion to receive 1 of 3 treatments: Symbicort (160 mcg of budesonide and 4.5 mcg of formoterol) administered twice daily and as needed; inhaled terbutaline 0.5 mg as needed along with maintenance therapy with twice-daily Symbicort (budesonide/formoterol 320/9 mcg); inhaled terbutaline 0.5 mg as needed plus a twice-daily combination of an ICS and long-acting beta-agonist (fluticasone/salmeterol 250/50 mcg).
The investigators used daytime symptoms, night-time awakenings, and lung function as defined by FEV1 as indicators of asthma control.
Dr. Kuna noted that asthma control was similarly improved in all treatment groups and that the SMART strategy prolonged the time to first severe asthma exacerbation compared to the groups using terbutaline as needed for asthma exacerbations. In addition, the SMART strategy was associated with 28% fewer exacerbations compared to budesonide/formoterol with as-needed terbutaline, and 39% fewer exacerbations than in the group maintained on fluticasone/salmeterol (both P <.01).
During the study period, 12% of those on the investigative strategy had exacerbations compared to 16% of those on fixed budesonide/formoterol and 19% of those on salmeterol/fluticasone. Patients on the investigative treatment had a cumulative ICS dose that was 25% less by beclomethasone equivalent than patients in the 2 fixed-dose groups.
"In our study, we found that patients using the SMART approach were able to resolve the exacerbation with a lower cumulative corticosteroid dose than did those who doubled the ICS dose for the duration of the exacerbation," Dr. Kuna said in an interview.
Symbicort is manufactured by AstraZeneca.
[Presentation title: Budesonide/Formoterol as Maintenance and Reliever Therapy Reduces Asthma Exacerbations Versus a Higher Maintenance Dose of Budesonide/Formoterol or Salmeterol/Fluticasone. Abstract 1228]
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