Clinical Evaluation of Tulobuterol Aerosol in Childhood Asthma

Abstract

An open clinical trial was performed to assess the efficacy and safety of 400 μg tulobuterol aerosol given four times daily in childhood bronchial asthma. A total of 54 children were enrolled with bronchial asthma shown to be reversible by an increase of forced expiratory volume in 1 s (FEV₁) of more than 15% following 200 (μg of salbutamol. Tulobuterol was administered for 3 weeks and regular use of salbutamol was continued for 12 patients during the 7-day lead-in period and six patients took theophylline throughout the study; other drugs were discontinued. The mean FEV₁, mean adjusted FEV₁, mean peak expiratory flow rate (PEFR) and mean forced vital capacity (FVC) were significantly increased (P < 0.001) following treatment. Mean FEV₁ increases ranged from 9.2% to 14.0%, with 24.5 – 43.4% of patients showing clinically significant increases of at least 15%. Globally, there was improvement in 46 patients (85%). Headache and nervous system complaints were the most common side-effects. Although this was an uncontrolled study, the indications are that tulobuterol aerosol is effective and safe for use in children with asthma.