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PEDIATRICS Vol. 109 No. 5 May 2002, pp. 866-872

Nebulized Budesonide Inhalation Suspension Compared With Cromolyn Sodium Nebulizer Solution for Asthma in Young Children: Results of a Randomized Outcomes Trial

Jeffrey G. Leflein, MD^*, Stanley J. Szefler, MD, Kevin R. Murphy, MD, Sherahe Fitzpatrick, MD^a, Mario Cruz-Rivera, PhD, MPH^¶, Christopher J. Miller, MStat^¶ and Joseph A. Smith, MD^¶

^* Allergy & Immunology Associates of Ann Arbor, Ann Arbor, Michigan
Helen Wohlberg & Herman Lambert Chair in Pharmacokinetics, Division of Clinical Pharmacology and Allergy/Immunology, National Jewish Medical and Research Center and the Departments of Pediatrics and Pharmacology, University of Colorado Health Sciences Center, Denver, Colorado
Midwest Allergy & Asthma Clinic, Midwest Childrens Chest Physicians, Omaha, Nebraska
^¶ AstraZeneca LP, Wilmington, Delaware

--> Objective. The availability of antiinflammatory asthma medications for infants and young children has been limited. The objective of this study was to compare effects of nebulized budesonide inhalation suspension and cromolyn sodium nebulizer solution on asthma-related health outcomes in young children with asthma.

Methods. We conducted a randomized, parallel-group, 52-week, open-label study in 36 US clinical sites. Patients included 335 children who were 2 to 6 years of age and had persistent asthma that had been treated with at least 1 long-term control medication; 287 children (86%) completed the study. Patients received budesonide inhalation suspension, 0.5 mg daily (n = 168), or cromolyn sodium nebulizer solution, 20 mg 4 times daily (n = 167), for 8 weeks, followed by dose titration at the investigator’s discretion. The main outcome measure was the rate of asthma exacerbations over 52 weeks. Secondary measures included times to first asthma exacerbation and first use of additional asthma therapy, asthma symptom scores, rescue medication use, and health care resource use.

Results. The budesonide group had a mean (median) asthma exacerbation rate of 1.23 (0.99) per year compared with 2.41 (1.85) for the cromolyn group, significantly longer times to first exacerbation and first use of additional long-term asthma medication, greater improvements in asthma symptom scores, reduced use of rescue medication, and fewer urgent care visits. Both treatments were well tolerated.

Conclusions. Budesonide inhalation suspension was more effective than nebulized cromolyn sodium in young children with persistent asthma. Both treatments were well tolerated with similar adverse event profiles.

Key Words: budesonide inhalation suspension • Pulmicort Respules • cromolyn sodium • nebulizer therapy

Abbreviations: ICS, inhaled corticosteroid • ACTH, adrenocorticotropic hormone • ANOVA, analysis of variance

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Received for publication Oct 5, 2001; Accepted Jan 31, 2002.

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