Nebulized budesonide inhalation suspension compared with cromolyn sodium nebulizer solution for asthma in young children: results of a randomized outcomes trial.
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.
Leflein
Jeffrey G
JG
Allergy & Immunology Associates of Ann Arbor, Ann Arbor, Michigan 48106, USA. mhurw78081@aol.com
Szefler
Stanley J
SJ
Murphy
Kevin R
KR
Fitzpatrick
Sherahe
S
Cruz-Rivera
Mario
M
Miller
Christopher J
CJ
Smith
Joseph A
JA
D000280:Administration, Inhalation; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D019819:Budesonide / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004205:Cromolyn Sodium / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006296:Health Services / Q000706:statistics & numerical data; D006801:Humans; D015993:Life Tables; D008297:Male; D009330:Nebulizers and Vaporizers; D013535:Suspensions; D016896:Treatment Outcome
D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents; D013535:Suspensions; D019819:Budesonide; D004205:Cromolyn Sodium