Clinical need for a nebulized corticosteroid.

Asthma is a leading cause of morbidity in children, leading to frequent emergency room visits and hospitalizations. In recent years, a steady increase in the number of cases of pediatric asthma has been observed. Mortality rates among children also have increased. The diagnosis of asthma in infants and young children relies on symptoms, and most children become symptomatic before the age of 2 years. The prognosis of an individual child is difficult to predict because of a lack of clear markers; however, respiratory symptoms that begin at, or persist through, the ages of 3 to 4 years are significantly associated with future asthma. The inflammatory nature of asthma has prompted recommendations for the routine use of inhaled corticosteroids for all patients with persistent asthma. Studies have indicated that early initiation of corticosteroid therapy can reduce airway inflammation and may prevent more serious asthma or irreversible obstruction in later years. Although treatment guidelines recommend the use of inhaled corticosteroids in infants and children younger than 5 years of age, metered-dose and dry-powder inhalers may be difficult for this population to use because of a lack of coordination or understanding. In addition, there are no commercially available inhaled corticosteroids for use in children younger than 4 years of age in the United States.