title: Safety of budesonide inhalation suspension in infants aged six to twelve months with mild to moderate persistent asthma or recurrent wheeze.
abstract: 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.
authors.affiliation: Allergy and Asthma Associates of Southern California, Mission Viejo, CA 92691, USA. Weberger@uci.edu
authors.forename: William E
authors.initials: WE
authors.lastname: Berger
authors.forename: Paul Y
authors.initials: PY
authors.lastname: Qaqundah
authors.forename: Kathryn
authors.initials: K
authors.lastname: Blake
authors.forename: Jose
authors.initials: J
authors.lastname: Rodriguez-Santana
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Irani
authors.forename: John
authors.initials: J
authors.lastname: Xu
authors.forename: Mitchell
authors.initials: M
authors.lastname: Goldman
mesh_terms: 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*
chemical_list: D001993:Bronchodilator Agents; D019819:Budesonide; D006854:Hydrocortisone