Effect of high starting dose of budesonide inhalation suspension on serum cortisol concentration in young children with recurrent wheezing episodes.
BACKGROUND
There are no available data on the safety of recommended schedules for the initiation of treatment with budesonide inhalation suspension in children with recurrent wheezing episodes. We compared the safety of high and low starting dose of budesonide by measuring their effect on plasma cortisol concentration.


METHODS
A randomized double-blind, placebo-controlled design was used. Twenty-nine children ages 6 months to 3 years were divided into three groups: (1) high starting dose: 1 mg budesonide inhalation suspension twice daily followed by a stepwise decrease of 25% every second day for 8 days (n = 11); (2) low starting dose: 0.25 mg twice daily for 8 days (n = 11); (3) placebo (n = 7). The 8 AM (fasting) and 1-hour post-ACTH stimulation plasma cortisol concentrations were measured before and 10 days after initiation of budesonide treatment.


RESULTS
Before treatment and after 8-10 days of treatment, there was no significant difference in mean serum cortisol concentration in the high starting dose, low-dose and placebo groups, either at 8 AM or at 1 hour after ACTH stimulation.


CONCLUSIONS
The administration of nebulized suspension of budesonide at a high starting dose (2 mg/day for 2 days) followed by a rapid stepwise decrease over 8 days was safe, causing similar changes in serum cortisol levels to low-dose budesonide suspension or placebo.
Volovitz
Benjamin
B
Asthma Clinic, Department of Pediatrics C, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. volovtiz@post.tau.ac.il
Nussinovitch
Moshe
M
D000280:Administration, Inhalation; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D019819:Budesonide / Q000008:administration & dosage* / Q000627:therapeutic use; D002675:Child, Preschool; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood*; D007223:Infant; D008297:Male; D009330:Nebulizers and Vaporizers; D012008:Recurrence; D012135:Respiratory Sounds / Q000503:physiopathology; D012449:Safety; D013997:Time Factors
D001993:Bronchodilator Agents; D019819:Budesonide; D006854:Hydrocortisone