title: Inhaled corticosteroid reduction and elimination in patients with persistent asthma receiving salmeterol: a randomized controlled trial.
abstract: BACKGROUND
  Inhaled long-acting beta(2)-agonists improve asthma control when added to inhaled corticosteroid (ICS) therapy.
  
  
  OBJECTIVE
  To determine whether ICS therapy can be reduced or eliminated in patients with persistent asthma after adding a long-acting beta(2)-agonist to their treatment regimen.
  
  
  METHODS
  A 24-week randomized, controlled, blinded, double-dummy, parallel-group trial conducted at 6 National Institutes of Health-sponsored, university-based ambulatory care centers from February 1997 through January 1999.
  
  
  METHODS
  One hundred seventy-five patients aged 12 through 65 years with persistent asthma that was suboptimally controlled during a 6-week run-in period of treatment with inhaled triamcinolone acetonide (400 microg twice per day).
  
  
  METHODS
  Patients continued triamcinolone therapy and were randomly assigned to receive add-on therapy with either placebo (placebo-minus group, n = 21) or salmeterol xinafoate, 42 microg twice per day (n = 154) for 2 weeks. The entire placebo-minus group was assigned and half of the salmeterol group (salmeterol-minus group) was randomly assigned to reduce by 50% (for 8 weeks) then eliminate (for 8 weeks) triamcinolone treatment. The other half of the salmeterol group (salmeterol-plus group) was randomly assigned to continue both salmeterol and triamcinolone for the remaining 16 weeks (active control group).
  
  
  METHODS
  Time to asthma treatment failure in patients receiving salmeterol.
  
  
  RESULTS
  Treatment failure occurred in 8.3% (95% confidence interval [CI], 2%-15%) of the salmeterol-minus group 8 weeks after triamcinolone treatment was reduced compared with 2.8% (95% CI, 0%-7%) of the salmeterol-plus group during the same period. Treatment failure occurred in 46.3% (95% CI, 34%-59%) of the salmeterol-minus group 8 weeks after triamcinolone therapy was eliminated compared with 13.7% (95% CI, 5%-22%) of the salmeterol-plus group. The relative risk (95% CI) of treatment failure at the end of the triamcinolone elimination phase in the salmeterol-minus group was 4.3 (2.0-9.2) compared with the salmeterol-plus group (P<.001).
  
  
  CONCLUSIONS
  Our results indicate that in patients with persistent asthma suboptimally controlled by triamcinolone therapy alone but whose asthma symptoms improve after addition of salmeterol, a substantial reduction (50%) in triamcinolone dose can occur without a significant loss of asthma control. However, total elimination of triamcinolone therapy results in a significant deterioration in asthma control and, therefore, cannot be recommended.
authors.affiliation: University of Wisconsin Children's Hospital, 600 Highland Ave, K4/916-9988, Madison, WI 53792, USA. rfl@medicine.wisc.edu
authors.forename: R F
authors.initials: RF
authors.lastname: Lemanske
authors.forename: C A
authors.initials: CA
authors.lastname: Sorkness
authors.forename: E A
authors.initials: EA
authors.lastname: Mauger
authors.forename: S C
authors.initials: SC
authors.lastname: Lazarus
authors.forename: H A
authors.initials: HA
authors.lastname: Boushey
authors.forename: J V
authors.initials: JV
authors.lastname: Fahy
authors.forename: J M
authors.initials: JM
authors.lastname: Drazen
authors.forename: V M
authors.initials: VM
authors.lastname: Chinchilli
authors.forename: T
authors.initials: T
authors.lastname: Craig
authors.forename: J E
authors.initials: JE
authors.lastname: Fish
authors.forename: J G
authors.initials: JG
authors.lastname: Ford
authors.forename: E
authors.initials: E
authors.lastname: Israel
authors.forename: M
authors.initials: M
authors.lastname: Kraft
authors.forename: R J
authors.initials: RJ
authors.lastname: Martin
authors.forename: S A
authors.initials: SA
authors.lastname: Nachman
authors.forename: S P
authors.initials: SP
authors.lastname: Peters
authors.forename: J D
authors.initials: JD
authors.lastname: Spahn
authors.forename: S J
authors.initials: SJ
authors.lastname: Szefler
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000627:therapeutic use*; D000328:Adult; D000420:Albuterol / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012129:Respiratory Function Tests; D000068299:Salmeterol Xinafoate; D018709:Statistics, Nonparametric; D017211:Treatment Failure; D014222:Triamcinolone Acetonide / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D000318:Adrenergic beta-Agonists; D000893:Anti-Inflammatory Agents; D000068299:Salmeterol Xinafoate; D014222:Triamcinolone Acetonide; D000420:Albuterol