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Background The increased use of inhaled corticosteroids in the management of asthma raises concern about the safety of these drugs in children. We sought to determine the safety of long-term administration of inhaled budesonide in young children with asthma.
Methods We studied 15 children 2 to 7 years old who had severe perennial asthma. They inhaled 100 µg of budesonide twice daily for three to five years. Efficacy was assessed by serial evaluation of respiratory symptoms and the need for other medications, and safety by serial evaluation of height, height velocity, weight, bone age, and pituitary-adrenal function.
Results The severity of asthma decreased within the first month after the initiation of therapy, as demonstrated by a 58 percent reduction in the number of days with symptoms of asthma and a 75 percent decrease in the use of bronchodilators. This improvement was maintained thereafter. The growth pattern of all patients, including their height, weight, and bone age, was normal (as compared with standard normal values) throughout the treatment period. Pituitary-adrenal function was not adversely affected by the treatment, as demonstrated by normal serum cortisol concentrations in the morning and 60 minutes after stimulation with corticotropin, normal 24-hour serum cortisol concentrations (mean [±SD] of samples collected at 30-minute intervals for 24 hours, 8.4 ±4.2 µg per deciliter [232 ±116 nmol per liter]), and normal urinary cortisol excretion (34 ±9 µg [95 ±25 nmol] per day).
Conclusions Prolonged administration of 200 µg of inhaled budesonide daily to young children with severe asthma does not impair growth or pituitary-adrenal function.
Source Information
Presented in part at the 14th International Congress of Allergology and Clinical Immunology, Kyoto, Japan, October 13-18, 1991.
From the Department of Pediatrics, Hasharon Hospital, Golda Medical Center, P.O.B. 121, Petach-Tiqva 49372, Israel, where reprint requests should be addressed to Dr. Volovitz.
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