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Budesonide/formoterol maintenance and reliever therapy in moderate-to-severe asthma: effects on eosinophilic airway inflammation.

Although the budesonide and formoterol in a single inhaler for maintenance and reliever therapy has been evaluated in recent studies, the effects on eosinophilic airway inflammation remain uncertain. The purpose of this study was to compare the efficacy, including anti-inflammatory effects, of as-needed budesonide/formoterol with salbutamol in Japanese patients with moderate-to-severe asthma. Patients with asthma using an inhaled corticosteroid plus a long-acting beta2-agonist as a controller and at least one asthma exacerbation in the previous 12 months were randomized to budesonide/formoterol maintenance therapy (160/4.5 micrograms, 2 inhalations twice daily) plus either as-needed budesonide/formoterol (160/4.5 micrograms; n = 32) or salbutamol (100 micrograms; n = 31) up to 4 inhalation daily for 48 weeks. The time to first asthma exacerbation was significantly prolonged with as-needed budesonide/formoterol compared with salbutamol (log-rank test; p = 0.0342). There was a 66% reduction in the hazard ratio for a first exacerbation with as-needed budesonide/formoterol (p = 0.0334). The frequencies of both mild and severe exacerbations and reliever use were consistently less with budesonide/formoterol than salbutamol. As-needed budesonide/formoterol significantly improved in lung function and symptom scores compared with salbutamol. In addition, the contents of eosinophil cationic protein and B12 tryptase, as well as number of eosinophils and mast cells in induced sputum, decreased to a greater extent with budesonide/formoterol compared with salbutamol. In conclusion, the budesonide and formoterol for maintenance and reliever therapy seems more effective in controlling persistent asthma with a significant reduction of airway inflammation. Clinical trial 121104, www.clinicaltrials.gov.