Controlled trial of budesonide given by the nebuhaler in preschool children with asthma.

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 Patients withdrawn if their acute attacks required treatment with systemic steroids.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.