Controlled trial of budesonide given by the nebuhaler in preschool children with asthma
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1Department of Child Health, King's College School of Medicine, London.
Insights
Inhaled budesonide effectively prevents asthma in preschool children. This study found budesonide significantly improved peak expiratory flow rates and reduced bronchodilator use in young asthmatics.
Area of Science:
- Pediatric Pulmonology
- Respiratory Medicine
- Pharmacology
Background:
- Asthma is a common chronic respiratory disease in preschool children.
- Effective prophylactic treatments are crucial for managing childhood asthma.
- The Nebuhaler device offers a potential delivery method for inhaled medications.
Purpose of the Study:
- To evaluate the efficacy of inhaled budesonide administered via a Nebuhaler for asthma prophylaxis in preschool children.
- To assess the impact of budesonide on asthma control and respiratory function.
Main Methods:
- A double-blind, placebo-controlled, randomized crossover trial was conducted.
- Participants included 39 children aged 2-6 years with poorly controlled asthma.
- Budesonide (200 mcg) or placebo was administered twice daily via Nebuhaler for 6-week periods, with a 3-week washout.
Main Results:
- Mean peak expiratory flow rate was significantly higher during budesonide treatment (12% morning, 14% evening) compared to placebo.
- Concomitant use of supplementary bronchodilator drugs decreased by 50% during budesonide intervention.
- No significant differences were noted in withdrawal reasons between groups, suggesting good tolerability.
Conclusions:
- Inhaled budesonide, delivered by Nebuhaler, is an effective prophylactic treatment for preschool children experiencing frequent asthma.
- This treatment improves respiratory function and reduces the need for rescue bronchodilators.
- Budesonide represents a viable therapeutic option for managing asthma in this young population.
Objective:
To determine whether the inhaled corticosteroid budesonide, given by a Nebuhaler spacing device, was effective in prophylaxis of asthma in preschool children.
Design:
Double blind, placebo controlled, random order crossover trial with two week practice run in period.
Setting:
Outpatient clinic referrals in secondary referral centre.
Patients:
39 children aged 2-6 years selected for the following: able to use Nebuhaler; parents able to complete record card; poorly controlled asthma (defined); not already on systemic or inhaled steroids. Eleven withdrew for various reasons not connected with intolerance to budesonide. Age, sex, other atopies, and symptoms during run in period were similar in the 28 children who completed the trial and in the 11 who withdrew.
Interventions:
Budesonide 200 micrograms or placebo (both one puff) given twice daily during 6-week treatment or control periods, using Nebuhaler after prior training. Three week "washout" at crossover. Compliance monitored by weighing canisters. Patients withdrawn if their acute attacks required treatment with systemic steroids.
End Point:
Control of asthma.
Measurements And Main Results:
Peak expiratory flow rate measured twice daily where cooperation allowed. Diary of symptoms and concomitant drug use kept daily. Results showed mean peak flow significantly higher (12% in mornings, 14% in evenings) in second three weeks of intervention compared with control period (95% confidence intervals 6.3-17.3% and 7.2-21.0%). Supplementary bronchodilator drugs reduced by 50% during intervention periods.
Conclusions:
Budesonide given by Nebuhaler is effective prophylaxis for preschool children with frequent asthma.