Efficacy and safety of budesonide inhalation suspension (Pulmicort Resp... https://pubmed.ncbi.nlm.nih.

gov/9819296/

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Clinical Trial J Allergy Clin Immunol. 1998 Nov;102(5):789-96.

doi: 10.1016/s0091-6749(98)70019-3.

Efficacy and safety of budesonide inhalation

suspension (Pulmicort Respules) in young children
with inhaled steroid-dependent, persistent asthma
G Shapiro 1 , L Mendelson, M J Kraemer, M Cruz-Rivera, K Walton-Bowen, J A Smith

Affiliations
PMID: 9819296 DOI: 10.1016/s0091-6749(98)70019-3

Abstract
Background: Inhaled glucocorticosteroids are indicated for the treatment of persistent asthma;
however, many young children are unable to effectively use currently available inhalers.

Objective: We sought to evaluate the efficacy and safety of 3 different twice daily doses of
budesonide inhalation suspension (Pulmicort Respules) in inhaled steroid-dependent asthmatic
children.

Methods: This was a 12-week, randomized, double-blind, placebo-controlled, parallel-group study

involving 178 children (age range, 4 to 8 years) at 17 centers in the United States. Budesonide
inhalation suspension doses of 0.25 mg, 0.50 mg, or 1.0 mg twice daily were administered by means
of a jet nebulizer and air compressor system. Efficacy was assessed by recording at home nighttime
and daytime asthma symptom scores, use of rescue medication, pulmonary function tests, and
treatment discontinuation because of worsening symptoms. Safety was assessed by reported adverse
events and changes in baseline and adrenocorticotrophic hormone-stimulated plasma cortisol levels
in a subset of patients.

Results: Baseline demographics, symptom scores, and pulmonary function data were similar across
treatment groups. All doses of budesonide inhalation suspension were superior to placebo in
improving nighttime and daytime asthma symptom scores (P </=.026), reducing use of breakthrough
medication (P </=.032), and improving morning peak expiratory flow (P </=.030). The number of
dropouts because of worsening asthma was also significantly fewer in the budesonide groups (P
</=.015). There were no differences between doses of budesonide. Adverse events and basal and
adrenocorticotrophic hormone-stimulated cortisol responses were not different between budesonide
and placebo groups.

Conclusion: Budesonide inhalation suspension, 0.25 mg, 0.50 mg, and 1.0 mg twice daily, is an
effective and safe treatment for young children with inhaled steroid-dependent, persistent asthma.

Comment in

1 of 2 2/9/2021, 7:21 PM
Efficacy and safety of budesonide inhalation suspension (Pulmicort Resp... https://pubmed.ncbi.nlm.nih.gov/9819296/

Early intervention for childhood asthma: inhaled glucocorticoids as the "preferred"

medication.
Szefler SJ.
J Allergy Clin Immunol. 1998 Nov;102(5):719-21. doi: 10.1016/s0091-6749(98)70009-0.
PMID: 9819286 No abstract available.

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