title: Asthma control can be maintained after fixed-dose, budesonide/ formoterol combination inhaler therapy is stepped down from medium to low dose.
abstract: BACKGROUND
  In cases using a budesonide/formoterol combination inhaler, many patients are started on fixed-dose treatment at 640/18μg (4 puffs) daily, but there are no guidelines yet regarding the step-down method when control has been maintained.
  
  
  METHODS
  Patients with moderate asthma treated with either budesonide 400μg and salmeterol 100μg (GINA step3 group) or salmeterol/fluticasone 250 at 2 puffs (GINA step4 group) were enrolled and started on therapy of budesonide/formoterol 4 puffs. Thereafter, step-down to 2 puffs was performed if either of the following criteria was met at 8-week intervals: fractional exhaled nitric oxide (FeNO) ≤ 28 ppb plus asthma control test (ACT) score ≥ 22, or ACT score ≥ 24 at 3 consecutive visits regardless of FeNO level. Thereafter, changes in ACT score, the number of acute exacerbations and reliever use, and FeNO level were monitored through 48th week.
  
  
  RESULTS
  Fifty-one patients, 27 in step3 group and 24 in step4 group, underwent step-down. ACT scores and the number of reliever use remained stable in both groups even after step-down. In contrast, FeNO levels increased gradually in step4 group, whereas in the step3 group they increased immediately after step-down. Step-down was considered to be safely performed because the numbers of reliever use and those of moderate or more severe exacerbations during the 48-week period has not changed significantly compared to before step-down.
  
  
  CONCLUSIONS
  If complete control of asthma, not only of clinical symptoms but also airway inflammation, is achieved by 3-6 months of fixed-dose budesonide/formoterol 4 puffs/day, it should be possible to safely perform step-down to 2 puffs/day.
authors.affiliation: Division of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan. mhojo@hosp.ncgm.go.jp
authors.forename: Masayuki
authors.initials: M
authors.lastname: Hojo
authors.forename: Tomonori
authors.initials: T
authors.lastname: Mizutani
authors.forename: Motoyasu
authors.initials: M
authors.lastname: Iikura
authors.forename: Satoshi
authors.initials: S
authors.lastname: Hirano
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Kobayashi
authors.forename: Haruhito
authors.initials: H
authors.lastname: Sugiyama
mesh_terms: D000280:Administration, Inhalation; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D019819:Budesonide / Q000008:administration & dosage*; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage*; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D009569:Nitric Oxide / Q000032:analysis; D012307:Risk Factors; D013147:Spirometry; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D000893:Anti-Inflammatory Agents; D004338:Drug Combinations; D004983:Ethanolamines; D009569:Nitric Oxide; D019819:Budesonide; D000068759:Formoterol Fumarate