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Budesonide: safety and efficacy aspects of its long-term use in children
1Pediatric Clinic, Lisbon, Portugal.
Insights
Budesonide therapy significantly improved lung function and reduced asthma symptoms in children over one year. This inhaled corticosteroid was well-tolerated, showing no adverse effects on growth or adrenal function in pediatric asthma patients.
Area of Science:
- Pediatric Pulmonology
- Clinical Pharmacology
Background:
- Asthma management in children often requires long-term therapy.
- Assessing the safety and efficacy of inhaled corticosteroids is crucial for pediatric populations.
Purpose of the Study:
- To evaluate the long-term safety and efficacy of budesonide in children with inadequately controlled asthma.
- To monitor growth and adrenal function during budesonide treatment.
Main Methods:
- Open-label, 12-month study involving 52 children (4-13 years) using budesonide (200 mcg BID) via a tube-spacer inhaler.
- Regular clinic visits for lung function tests, height measurements, and adrenal function tests.
- Parental diary cards for daily monitoring of peak expiratory flow (PEF), symptoms, and medication use.
Main Results:
- Significant improvements observed in all lung function tests and diary card PEF.
- Marked decreases in asthma symptoms, beta 2-agonist use, and other medications.
- No adverse effects on growth or basal adrenal function; adrenal response to Synacthen increased significantly. No serious adverse events reported.
Conclusions:
- Regular budesonide therapy demonstrates significant efficacy in improving lung function and asthma control in children over one year.
- Budesonide is well-tolerated in pediatric patients, with no negative impact on growth or adrenal function.
Abstract:
Fifty-two asthmatic children aged 4 to 13 years (mean 9.6) were enrolled in this open 12-month study of budesonide, 200 mcg bid, administered by tube-spacer inhaler (INHALET, ASTRA DRACO). The aim of the study was to assess long-term safety, as well as efficacy, of budesonide in children whose asthma was not adequately controlled by their current therapy. Children attended the clinic every three months for assessment of lung function and height. In addition, an adrenal function test and routine clinical chemistry and haematology were performed. Parents completed diary cards once each week, recording the child's PEF, asthma symptoms, beta 2-agonist consumption and other medication (no prophylactic drugs or other inhaled steroids were allowed and oral steroids were used for emergency treatment only). There were significant increases in all clinic lung function tests (baseline to last visit) and in diary card PEF (first 3 months vs last 3 months). These were accompanied by decreases in asthma symptoms and use of beta 2-agonists or other medication. There was no indication that growth was affected by study treatment and basal adrenal function (basal cortisol) did not change significantly throughout the study. The adrenal response to Synacthen had actually increased significantly by the end of the study. No serious adverse events were associated with budesonide treatment. In conclusion, regular budesonide therapy was associated with a significant improvement in lung function and symptoms over one year. Budesonide was well-tolerated by the children and appeared to have no adverse influence on either growth or adrenal function.