Clinical efficacy and safety of budesonide Turbuhaler as compared to MDIs in children.

Pharmacokinetic studies in children indicate that budesonide by Turbuhaler results in higher intrabronchial deposition of drug but a higher systemic activity than the same dose of budesonide inhaled from a Nebuhaler. Furthermore, around 85% of the total systemic activity is caused by drug absorbed from the lungs. Therefore, subsequent studies have been performed to compare the clinical and/or systemic effect of these two inhalers. The findings in all these studies were in agreement with the findings of the pharmacokinetic studies: (1) In a double-blind crossover study, urinary cortisol excretion was reduced during Turbuhaler but not during Nebuhaler treatment. At the same time the Turbuhaler seemed clinically more effective than the Nebuhaler. (2) A double-blind parallel-group study on 126 children showed no deterioration in asthma control when the dose of budesonide was reduced by 50% when the children used the Turbuhaler. When the Nebuhaler was used a dose reduction resulted in deterioration of asthma control. (3) When the dose of budesonide delivered to the patient was measured by analysing the amount of drug deposited on a filter inserted between the patient's lips during inhalation, it was found that twice as much budesonide was deposited after Turbuhaler as after Nebuhaler treatment. (4) When the dose of budesonide required by 224 children followed in our outpatient clinic was recorded, we found that the mean daily dose in children using the Turbuhaler was 50% lower than the dose required by children using the Nebuhaler.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes