title: Daily or intermittent budesonide in preschool children with recurrent wheezing.
abstract: BACKGROUND
  Daily inhaled glucocorticoids are recommended for young children at risk for asthma exacerbations, as indicated by a positive value on the modified asthma predictive index (API) and an exacerbation in the preceding year, but concern remains about daily adherence and effects on growth. We compared daily therapy with intermittent therapy.
  
  
  METHODS
  We studied 278 children between the ages of 12 and 53 months who had positive values on the modified API, recurrent wheezing episodes, and at least one exacerbation in the previous year but a low degree of impairment. Children were randomly assigned to receive a budesonide inhalation suspension for 1 year as either an intermittent high-dose regimen (1 mg twice daily for 7 days, starting early during a predefined respiratory tract illness) or a daily low-dose regimen (0.5 mg nightly) with corresponding placebos. The primary outcome was the frequency of exacerbations requiring oral glucocorticoid therapy.
  
  
  RESULTS
  The daily regimen of budesonide did not differ significantly from the intermittent regimen with respect to the frequency of exacerbations, with a rate per patient-year for the daily regimen of 0.97 (95% confidence interval [CI], 0.76 to 1.22) versus a rate of 0.95 (95% CI, 0.75 to 1.20) for the intermittent regimen (relative rate in the intermittent-regimen group, 0.99; 95% CI, 0.71 to 1.35; P=0.60). There were also no significant between-group differences in several other measures of asthma severity, including the time to the first exacerbation, or adverse events. The mean exposure to budesonide was 104 mg less with the intermittent regimen than with the daily regimen.
  
  
  CONCLUSIONS
  A daily low-dose regimen of budesonide was not superior to an intermittent high-dose regimen in reducing asthma exacerbations. Daily administration led to greater exposure to the drug at 1 year. (Funded by the National Heart, Lung, and Blood Institute and others; MIST ClinicalTrials.gov number, NCT00675584.).
authors: Department of Allergy, Kaiser Permanente Southern California, San Diego, CA 92111, USA. robert.s.zeiger@kp.org
authors: Robert S
authors: RS
authors: Zeiger
authors: David
authors: D
authors: Mauger
authors: Leonard B
authors: LB
authors: Bacharier
authors: Theresa W
authors: TW
authors: Guilbert
authors: Fernando D
authors: FD
authors: Martinez
authors: Robert F
authors: RF
authors: Lemanske
authors: Robert C
authors: RC
authors: Strunk
authors: Ronina
authors: R
authors: Covar
authors: Stanley J
authors: SJ
authors: Szefler
authors: Susan
authors: S
authors: Boehmer
authors: Daniel J
authors: DJ
authors: Jackson
authors: Christine A
authors: CA
authors: Sorkness
authors: James E
authors: JE
authors: Gern
authors: H William
authors: HW
authors: Kelly
authors: Noah J
authors: NJ
authors: Friedman
authors: Michael H
authors: MH
authors: Mellon
authors: Michael
authors: M
authors: Schatz
authors: Wayne J
authors: WJ
authors: Morgan
authors: Vernon M
authors: VM
authors: Chinchilli
authors: Hengameh H
authors: HH
authors: Raissy
authors: Elizabeth
authors: E
authors: Bade
authors: Jonathan
authors: J
authors: Malka-Rais
authors: Avraham
authors: A
authors: Beigelman
authors: Lynn M
authors: LM
authors: Taussig
mesh_terms: D000280:Administration, Inhalation; D000284:Administration, Oral; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects; D002675:Child, Preschool; D004334:Drug Administration Schedule; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D008297:Male; D011239:Prednisolone / Q000627:therapeutic use; D012135:Respiratory Sounds / Q000187:drug effects; D012720:Severity of Illness Index; D017211:Treatment Failure
chemical_list: D001993:Bronchodilator Agents; D005938:Glucocorticoids; D019819:Budesonide; D011239:Prednisolone