Efficacy of nebulized budesonide in treatment of severe infantile asthma: A double-blind study,☆☆,

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Abstract

Background and Objective: Treatments with inhaled corticosteroids yielded conflicting results in infants with severe asthma. The purpose of this study was to assess the efficacy of nebulized budesonide on the control of asthma in this age group. Methods: In a double-blind, placebo-controlled study, 40 infants with severe asthma received either nebulized budesonide (1 mg) or placebo twice daily for 12 weeks, followed by a follow-up period of up to 12 weeks. A jet nebulizer driven by an air compressor was used to administer budesonide and placebo. Results: Fewer patients in the budesonide group had an exacerbation during the treatment period (40%) compared with the placebo group (83%, p < 0.01). The duration of oral steroid therapy was shorter in the budesonide group than in the placebo group (median number of days of exacerbation as a proportion of the total treatment time, 0% vs 14.5%; p < 0.05). The incidence of daytime (p < 0.05) and nighttime wheezing (p < 0.01) was lower in the budesonide group than in the placebo group during the treatment period. The proportion of patients without an exacerbation of asthma during the entire 24 weeks was 28% for those patients who had received budesonide and 0% for those patients who had received placebo. Asthma improved in more patients in the budesonide group (17 of 19, 89%) than in the placebo group (7 of 16, 44%; p < 0.005). These results should improve and modify the treatment of infants with severe asthma. Conclusion: Nebulized budesonide (1 mg twice daily) is a well-tolerated and efficient treatment for severe infantile asthma. (J ALLERGY CLIN IMMUNOL 1996;98:14-20.)

Section snippets

METHODS

Infants were recruited for study from Hôpital des Enfants Malades, Paris, France between December 1991 and February 1992.

Diagnosis of asthma was defined by at least three exacerbations of dyspnea associated with wheezing during the 12 months before the study. Severe asthma was defined as either one exacerbation per month requiring oral steroid administration during the 3 months before inclusion in the study or persistent asthma with daily symptoms for at least 15 days before inclusion. Informed

RESULTS

Forty patients, 35 boys and 5 girls, with a mean age of 17 months (range, 6 to 30 months) were recruited for study. Thirty-five patients completed the 12-week treatment period; three patients were withdrawn prematurely: one was withdrawn because of lack of efficacy (placebo group), one was lost to follow-up (placebo group), and one could not tolerate the device (budesonide group). Two patients in the placebo group were excluded from the analysis because they had no data apart from the data

DISCUSSION

Our results provide evidence that the administration of 1 mg of nebulized budesonide twice daily for 12 weeks was an effective treatment for severe asthma in children younger than 30 months of age. Significantly fewer patients in the budesonide group had exacerbations requiring administration of oral corticosteroids, and for those who had such exacerbations, the duration of oral corticosteroid therapy decreased. The incidence of daytime and nighttime wheezing was lower in the budesonide group

Acknowledgements

We thank Madeline Frame, of ASTRA International Medical Services, Hemel Hempstead, England, for reviewing the manuscript.

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    From aHôpital des Enfants Malades, Paris; bLaboratoires ASTRA-FRANCE, Nanterre; and cASTRA International Medical Services, Hemel, Hempstead.

    ☆☆

    Reprint requests: Jacques de Blic, MD, Service de Pneumologie et d’Allergologie Pédiatriques, Hôpital des Enfants Malades, 149 rue de Sèvres, 75730 Paris Cedex 15, France.

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