Efficacy and safety of isoproterenol continuous inhalation treatment for acute severe exacerbation of asthma in children; a randomized, double-blind controlled study

Background: Japanese pediatric guideline for asthma recommends isoproterenol continuous inhalation treatment (ICIT) for acute severe exacerbation of asthma, although expert panel report 3 recommends continuous nebulization of SABA, mainly with salbutamol. Aim: To investigate the efficacy and safety of ICIT for acute severe exacerbation of asthma in children. Method: In this randomized, double-blind, double-dummy controlled study, we recruited children with severe acute exacerbation of asthma. Patients were assigned to receive ICIT or salbutamol continuous inhalation treatment (SAL), both of which were administered for 12 hours via large volume nebulizer. The primary outcome was the change of modified pulmonary index score (MPIS) at 3 hours. Other outcomes included the changes of MPIS at 12 hours, general improvement of respiratory symptoms, and the changes respiratory ratio and pulse ratio. Safety including drug concentration in plasma was also assessed. Results: 83 patients were enrolled, and 82 were analyzed for the full analysis set. The changes of MPIS at 3 hours significantly reduced in ICIT in comparison with SAL (mean ± SD: -2.88 ± 2.52 vs -0.88 ± 2.26, p Conclusion: ICIT showed significant improvement for severe acute asthma exacerbation in safer manner in comparison with SAL. ICIT is superior to SAL as a treatment for acute asthma exacerbation in children.