Inhaled Corticosteroid Reduction and Elimination in Patients With Persistent Asthma Receiving SalmeterolA Randomized Controlled Trial

Abstract

Research from JAMA — Inhaled Corticosteroid Reduction and Elimination in Patients With Persistent Asthma Receiving Salmeterol — A Randomized Controlled Trial — ContextInhaled long-acting β2-agonists improve asthma control when added to inhaled corticosteroid (ICS) therapy.ObjectiveTo determine whether ICS therapy can be reduced or eliminated in patients with persistent asthma after adding a long-acting β2-agonist to their treatment regimen.Design and SettingA 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.ParticipantsOne 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 µg twice per day).InterventionPatients continued triamcinolone therapy and were randomly assigned to receive add-on therapy with either placebo (placebo-minus group, n = 21) or salmeterol xinafoate, 42 µg 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).Main Outcome MeasureTime to asthma treatment failure in patients receiving salmeterol.ResultsTreatment 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).ConclusionsOur 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.