Inhaled corticosteroid reduction and elimination in patients with persistent asthma receiving salmeterol - A randomized controlled trial

Context Inhaled long-acting beta (2)-agonists improve asthma control when a dded 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. Design and Setting A 24-week randomized, controlled, blinded, double-dummy, parallel-group trial conducted at 6 National Institutes of Health-sponsore d, university-based ambulatory care centers from February 1997 through Janu ary 1999. Participants One hundred seventy-five patients aged 12 through 65 years wit h persistent asthma that was suboptimally controlled during a 6-week run-in period of treatment with inhaled triamcinolone acetonide (400 mug twice pe r day). Intervention Patients continued triamcinolone therapy and were randomly ass igned to receive add-on therapy with either placebo (placebo-minus group, n =21) or salmeterol xinafoate, 42 mug twice per day (n = 154) for 2 weeks. T he entire placebo-minus group was assigned and half of the salmeterol group (salmeterol-minus group) was randomly assigned to reduce by 50% (for 8 wee ks) then eliminate (for 8 weeks) triamcinolone treatment. The other half of the salmeterol group (salmeterol-plus group) was randomly assigned to cont inue both salmeterol and triamcinolone for the remaining 16 weeks (active c ontrol group). Main Outcome Measure 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%-5 9%) of the salmeterol-minus group 8 weeks after triamcinolone therapy was e liminated 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 triamci nolone elimination phase in the salmeterol-minus group was 4.3 (2.0-9.2) co mpared with the salmeterol-plus group (P<.001). Conclusions Our results indicate that in patients with persistent asthma su boptimally controlled by triamcinolone therapy alone but whose asthma sympt oms 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 significan t deterioration in asthma control and, therefore, cannot be recommended.