Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma

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Abstract
SUMMARYObjectives: This study evaluated the efficacy and safety of a novel asthma management strategy – budesonide/formoterol for both maintenance and symptom relief (Symbicort Single Inhaler Therapy*) – compared with a higher maintenance dose of budesonide in patients with moderate to severe asthma.Methods: This was a 12-month, randomised, double-blind, parallel-group study. Symptomatic patients with asthma (n = 1890; mean age 43 years [range 11 years–80 years], mean baseline forced expiratory volume in 1 s [FEV1] 70% of predicted, mean inhaled corticosteroid [ICS] dose 746 µg/day) received either budesonide (160 µg, 2 inhalations twice daily) plus terbutaline 0.4 mg as needed or a daily maintenance dose of budesonide/formoterol (160/4.5 µg, 2 inhalations once daily) with additional inhalations of budesonide/formoterol 160/4.5 µg as needed. Time to first severe exacerbation (hospitalisation/emergency room [ER] treatment or systemic steroids due to asthma worsening or a fall in morning peak expiratory flo...