STUDY OFFERS NEW APPROACH FOR INFANTS AND YOUNG CHILDREN WITH ASTHMA

A once-daily treatment regimen using a nebulized inhaled corticosteroid, budesonide, improved the control of asthma in infants and young children, according to the results of a newly published study in the September issue of the Annals of Allergy, Asthma and Immunology.

In the U.S. there are currently no inhaled corticosteroids approved for use in asthmatic children under age four. The nebulized form of budesonide, developed by AstraZeneca LP, is known as budesonide inhalation suspension and is marketed in Europe as Pulmicort RespulesTM. This medication is currently under review by the U.S. Food and Drug Administration for the treatment of asthma in infants and young children.

The 12-week study, entitled, "Once-daily budesonide inhalation suspension for the treatment of persistent asthma in infants and young children," evaluated the efficacy and safety of nebulized budesonide used once daily in children six months to eight years old who had mild persistent asthma and were not being treated with inhaled corticosteroids. Authors noted that in preliminary studies budesonide inhalation suspension, administered twice daily, had reduced asthma symptoms in infants and young children. On the basis of this data, the potential to administer treatments once daily was investigated.

The study was conducted as a randomized, double-blind, placebo-controlled, parallel-group study involving 359 pediatric patients at 26 centers in the United States. Patients received once-daily doses of budesonide inhalation suspension (0.25, 0.5, 1.0 mg) or placebo. Each treatment administration lasted approximately five minutes per day. Following the 12 weeks of therapy, all of the budesonide inhalation suspension doses produced significant improvements in nighttime and daytime asthma symptoms and significant decreases in the use of bronchodilators (rescue medications used to relieve asthma attacks) compared to placebo. Treatment with the nebulized budesonide was also associated with improved lung function in those patients capable of consistently performing pulmonary function tests.

Adverse events and basal and ACTH-stimulated cortisol levels were similar among all groups, including the placebo group. The most frequently reported adverse events were respiratory infection, fever, sinusitis and rhinitis. There were no serious adverse events attributed to the study medication during the 12-week study period.

Authors concluded that the once-daily use of budesonide inhalation suspension was well-tolerated in infants and young children with mild persistent asthma not adequately controlled with bronchodilators or non-steroidal anti-inflammatory treatments and demonstrated clinical benefits for this study population.

About Childhood Asthma and Treatment in the U.S.

Asthma is the most common chronic pediatric disease and affects nearly five million children in the U.S.  [1] with as many as 80% demonstrating symptoms before age five  [2]. Currently, the available medications used to treat asthmatic infants and young children are limited to oral and nebulized formulations of bronchodilators, oral steroids and nebulized non-steroidal anti-inflammatory treatments.

The U.S. National Institutes of Health consider inhaled corticosteroids to be the most effective long-term treatments for controlling persistent asthma. However, current corticosteroids available in the U.S. are contained in delivery devices that require a level of coordination and understanding that young children generally lack given their developmental stage. The study medication, budesonide inhalation suspension, was delivered by a nebulizer, a device that transforms the liquid-based medication into a mist that is then inhaled without requiring coordination or active deep inhalation. At present, there are no approved nebulized formulations of corticosteroids in the U.S.