Safety of budesonide inhalation suspension in infants aged six to twelve months with mild to moderate persistent asthma or recurrent wheeze.
OBJECTIVE
To compare the safety of budesonide inhalation suspension (BIS) with placebo in infants 6 to 12 months of age with mild to moderate persistent asthma or recurrent wheeze.


METHODS
In this multicenter, randomized, double-blinded, parallel-group, placebo-controlled study, 141 patients received 0.5 mg BIS (n = 48), 1.0 mg BIS (n = 44), or placebo (n = 49) once daily for 12 weeks. The primary variable was adrenal function, based on cosyntropin-stimulated plasma cortisol levels. Spontaneous adverse events and clinical laboratory findings also were monitored.


RESULTS
Overall, the types and frequencies of adverse events reported during the study were comparable across treatment groups. The response to cosyntropin stimulation was similar across treatment groups, with no significant difference between BIS treatment and placebo.


CONCLUSIONS
The safety profile of BIS was similar to that of placebo, with no suppressive effect on adrenal function in patients 6 to 12 months of age with mild to moderate persistent asthma or recurrent wheeze.
Berger
William E
WE
Allergy and Asthma Associates of Southern California, Mission Viejo, CA 92691, USA. Weberger@uci.edu
Qaqundah
Paul Y
PY
Blake
Kathryn
K
Rodriguez-Santana
Jose
J
Irani
Anne-Marie
AM
Xu
John
J
Goldman
Mitchell
M
D000280:Administration, Inhalation; D000311:Adrenal Glands / Q000187:drug effects / Q000378:metabolism; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D007223:Infant; D008297:Male; D009330:Nebulizers and Vaporizers; D012135:Respiratory Sounds / Q000187:drug effects*
D001993:Bronchodilator Agents; D019819:Budesonide; D006854:Hydrocortisone