Comparative study using oral solutions of bambuterol once daily or terbutaline three times daily in 2-5-year-old children with asthma

The aim of this study was to compare safety and efficacy of bambuterol hydr ochloride (10 mg) oral solution administered once daily in the evening with terbutaline sulphate (0.075 mg/kg body weight) oral solution administered three times daily in 2-5-year-old children with asthma. There were two trea tment groups: 2/3 of the patients received bambuterol and 1/3 received terb utaline. The study was double-blind, randomized, and of a parallel group de sign, and it lasted for 3 months after a 2-week run-in period. The primary objective was to evaluate safety (adverse events, and changes in blood pres sure, pulse rate, hematology, and clinical chemistry parameters). Plasma co ncentrations of terbutaline and/or bambuterol were also measured. Evaluatio n of efficacy (diary card data) was a secondary objective. A total of 155 p atients (range, 2-6 years; 3 patients were 6 years old at randomization) we re treated with the study drugs; 104 patients received bambuterol and 51 pa tients received terbutaline. Both treatments showed a good safety profile with respect to clinical and l aboratory tests, and they were generally well tolerated. Reported adverse e vents were mild to moderate. There were no statistically significant differ ences between treatment groups in any of the efficacy variables (diary vari ables: peak expiratory flow (PEF), asthma symptoms, restlessness, other rep orted symptoms, use of inhaled bronchodilators, and nighttime awakenings). For morning PEF, the mean increase from run-in to treatment was 16.9 L/min in the terbutaline group and 23.3 L/min in the bambuterol group. For evenin g PEF, the mean increase was 20.2 L/min in the terbutaline group and 20.6 L /min in the bambuterol group. In conclusion. once-daily bambuterol is as safe and effective as terbutalin e given three times daily. The study also confirmed that bambuterol has a 2 4-hr duration of action, and therefore its once daily administration, makes it a preferred bronchodilator agent. Pediatr Pulmonol, 2000: 29:194-201. ( C) 2000 Wiley-Liss, Inc.