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

医学 布地奈德 哮喘 雾化器 恶化 吸入 色甘酸钠 随机对照试验 麻醉 吸入器 儿科 内科学
作者
Jeffrey Leflein,Stanley J. Szefler,Kevin R. Murphy,Sherahe Fitzpatrick,Mario Cruz‐Rivera,Christopher J. Miller,Joseph A. Smith
出处
期刊:Pediatrics [American Academy of Pediatrics]
卷期号:109 (5): 866-872 被引量:78
标识
DOI:10.1542/peds.109.5.866
摘要

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.

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