Objective: To determine whether initiation of maintenance treatment with the salmeterol (S)/fluticasone propionate (FP) combination (Seretide/Viani/Advair) is more effective than inhaled steroid alone in patients with asthma symptomatic on short-acting bronchodilator alone.
Design: 150 asthma patients with symptoms and prn use of short-acting bronchodilator at least once a week were randomised to 24 weeks' treatment with either S/FP 50/100 microg bd (n = 78) or FP 100 microg bd (n = 72). The primary endpoint was the percentage of symptom-free 'day + night's.
Results: The percentage of symptom-free 'day + night's increased significantly more for S/FP (20 to 64%) compared to FP (24 to 51%). The treatment difference was 15.3%, P = 0.008. In the sub-group of patients with mild asthma the treatment difference was also statistically significant in favour of S/FP (P = 0.0245, n = 74). S/FP was also significantly superior to FP alone for: lung function, salbutamol use prn, day symptom score, symptom-free days, and episode-free 'day + night's. Treatments were equally well tolerated.
Conclusion: Initial maintenance treatment with S/FP is significantly more effective than with inhaled steroid alone for patients symptomatic when treated with short-acting bronchodilator alone. This also apply to patients with mild persistent asthma.