title: Long-term safety of once-daily budesonide in patients with early-onset mild persistent asthma: results of the Inhaled Steroid Treatment as Regular Therapy in Early Asthma (START) study.
abstract: BACKGROUND
  The Inhaled Steroid Treatment as Regular Therapy in Early Asthma (START) study is a worldwide, randomized, prospective study to investigate early intervention with inhaled corticosteroids in recent-onset mild persistent asthma.
  
  
  OBJECTIVE
  To evaluate the safety and tolerability of long-term treatment with once-daily budesonide therapy in patients with mild persistent asthma.
  
  
  METHODS
  Patients aged 5 to 66 years with mild persistent asthma for fewer than 2 years and no previous regular corticosteroid treatment received budesonide or placebo once daily for 3 years, in addition to their usual asthma therapy. The daily budesonide dose was 200 microg for children younger than 11 years and 400 microg for those 11 years or older.
  
  
  RESULTS
  Overall, 7,221 patients were included in the safety analysis, and a total of 21,520 adverse events were reported (10,850 in the budesonide group and 10,670 in the placebo group). The most commonly reported events included respiratory infections, rhinitis, pharyngitis, bronchitis, viral infections, and sinusitis. The number of deaths and serious adverse events were similar for children and adults in both treatment groups. Fewer asthma-related serious adverse events were reported with budesonide (162) compared with placebo (276). Oral candidiasis was reported more frequently with budesonide (1.2%) than with placebo (0.5%); the frequencies of other adverse effects previously reported to be associated with inhaled corticosteroids (psychiatric disorders, skin disorders, and allergic reactions) were similar.
  
  
  CONCLUSIONS
  Three-year treatment with budesonide once daily (200 or 400 microg) is safe and well tolerated in children and adults with newly detected mild persistent asthma.
authors.affiliation: Allergy Immunology Section, Brigham & Women's Hospital, Boston, Massachusetts 02467, USA. asheffer@partners.org
authors.forename: Albert L
authors.initials: AL
authors.lastname: Sheffer
authors.forename: Mike
authors.initials: M
authors.lastname: Silverman
authors.forename: Ann J
authors.initials: AJ
authors.lastname: Woolcock
authors.forename: Patricia V
authors.initials: PV
authors.lastname: Díaz
authors.forename: Bengt
authors.initials: B
authors.lastname: Lindberg
authors.forename: Bertil
authors.initials: B
authors.lastname: Lindmark
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000188:drug therapy*; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D000893:Anti-Inflammatory Agents; D019819:Budesonide