Infants and young children are often unable to use many formulations of inhaled glucocorticosteroids because of technical problems with delivery of the medication. Budesonide inhalation suspension, which can be administered at therapeutic concentrations by nebulization, has been shown to improve asthma in young children, but studies have not been performed in young children to compare different dosages and frequencies against placebo. Baker and colleagues evaluated the efficacy and safety of different dosing regimens in 481 infants and children with moderate persistent asthma.

The 12-week, double-blind, placebo-controlled study included boys and girls between six months and eight years of age. Eligibility criteria included use of at least one asthma medication every day and use of a rescue bronchodilator medication periodically during the three months before the study. Exacerbations of cough or wheezing during the six months before the study were also required. Patients old enough to perform spirometry had to be able to achieve a forced expiratory volume in one second (FEV₁) of at least 50 percent of the predicted value, with 15 percent reversibility demonstrated after a standard dose of an inhaled bronchodilator.

Patients were randomized to receive either placebo or one of the following treatment regimens: (1) 0.25 mg of budesonide inhalation suspension every morning and placebo every evening; (2) 0.25 mg of budesonide inhalation suspension twice daily; (3) 0.5 mg of budesonide inhalation suspension twice daily; or (4) 1.0 mg of budesonide inhalation suspension every morning and placebo every evening. Albuterol was available for use as a rescue medication. The five groups were similar at baseline with respect to duration of asthma and symptom scores, and the number of subjects in each group ranged from 95 to 99.

Physical examination, interval history and spirometry (when possible) were completed periodically throughout the study period. The childrens' parents kept daily records of asthma severity, rating the symptoms on a scale of zero to 3.

Asthma symptom scores showed significant improvement with budesonide dosages of 0.25 mg twice daily, 0.5 mg twice daily and 1.0 mg once daily, compared with placebo. However, a dosage of 0.25 mg once daily did not result in significant improvement compared with placebo. In children who were able to perform the maneuvers for pulmonary function testing, FEV₁ showed numerical improvement in all treatment groups, but a statistically significant improvement occurred only in the group that received a dosage of 0.5 mg twice daily. The average reduction in the number of days on which rescue medication was required was 4.4 days with 0.25 mg daily, 5.2 days with 0.25 mg twice daily, 4.9 days with 0.5 mg twice daily and 4.4 days with 1.0 mg daily.

The authors conclude that budesonide inhalation suspension offers a safe and effective means of providing corticosteroid therapy to even very young children with asthma. This formulation can be given twice daily or even once daily.