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| |  Budesonide, Alone or in Combination With Formoterol, Appears to Ease Asthma Symptoms in a Hispanic Population: Presented at ACAAI By Micheal Casasnovas MIAMI BEACH, Fla -- November 12, 2009 -- Researchers found that combination therapy with budesonide/formoterol as well as budesonide monotherapy were effective in a Hispanic population with asthma. In a poster presentation held here at the American College of Allergy, Asthma & Immunology (ACAAI) annual scientific meeting, the presenters said that they were seeking a Hispanic population because evidence suggests Hispanic patients with asthma have greater asthma-related mortality and barriers to asthma management than other ethnic groups. While the study was expected to evaluate use of the drugs in patients with moderate to severe asthma, a follow-up analysis found that many of the patients were not as sick as originally thought. “Stratification based on change in flow expiratory volume during the low-dose budesonide run-in indicates that the majority of patients were substantially milder than intended and would generally be overtreated by the doses of inhaled corticosteroids and inhaled corticosteroids/long-acting beta2-adrenergic agonist used here,” said Christopher D. O’Brien, MD, PhD, AstraZeneca, Wilmington, Delaware. He said that researchers suggested there might be a problem in the study because when patients were taken off medicine in the run-in part of the study, many of the patients actually improved on lower levels of treatment. When the investigators analysed just the patients who showed deterioration in forced expiratory flow in 1 second (FEV1) with withdrawal of medication, then the impact of medication was observed. The peak expiratory volume markedly increased with the combination product rather than with budesonide alone, in both morning and evening tests, Dr. O’Brien said November 7. This 12-week, active-controlled study was double-blind and randomised. Based on a historical baseline requirement of medium- to high-dose inhaled corticosteroid, researchers enrolled 250 Hispanic patients at least 12 years of age who were believed to have moderate to severe asthma. Patients underwent a 2-week run-in where they were stepped down to low-dose budesonide pressurised metered-dose inhaler 80 mcg in 2 inhalations twice daily. Patients with a symptom score greater than 0 on the 0-3 scale on at least 3 of 7 run-in days and flow expiratory volume, 45% to 85% predicted were randomised to budesonide/formoterol pressurised metered-dose inhaler 160/4.5 mcg x 2 inhalations (320/9 mcg) twice daily (n = 127) or budesonide pressurised metered-dose inhaler 160 mcg x 2 inhalations (320 mcg) twice daily (n = 123). Researchers found that the combination budesonide/formoterol pressurised metered-dose inhaler therapy and budesonide pressurised metered-dose inhaler monotherapy were effective in this Hispanic population with asthma. Overall, the change in budesonide/formoterol combination in peak expiratory flow was 25.4 L/min when compared with baseline, and was 19.9 L/min with budesonide alone during the morning test. The same pattern was seen in the evening where combination treatment resulted in a 20.6 L/min change compared with 15.8 L/min with budesonide monotherapy. However, neither of those differences achieved statistical significance. Dr. O’Brien said that one of the lessons in the study was to recognize that when doing studies, it is important to make sure “the population you think you are treating is really the population of patients in the study.” [Presentation Title: Efficacy of Budesonide/Formoterol (BUD/FM) vs BUD in Hispanic Patients: Differential Results When Including Run-in Lung Function vs Controller History and Run-in Symptoms. Abstract P72]
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