Addition of salmeterol to fluticasone propionate treatment in moderate-to-severe asthma

This study was designed to determine whether the benefit of adding salmeterol was superior to doubling the dose of fluticasone propionate (FP) over 6 months, compared to a control group who remained on a lower dose of FP The multi-centre, double-blind, parallel group study involved 496 symptomatic asthmatic patients with a history of exacerbations on 500-800 micrograms ( mug) inhaled corticosteroids (ICS) twice daily (b.d) in a broadly representative group of 100 hospitals and general practices in six countries. Two doses of FP-250 mug b.d. (FP250) or 500 mug b.d. (FP500)-were compared with the lower dose of FP plus a long-acting beta(2)-agonist, salmeterol 50 mug b.d. (SM/FP250). Patients symptomatic on the run-in dose of FP250 alone formed the control group in the treatment period. Over 6 months, SM/FP250 significantly improved mean morning peak expiratory flow rates (amPEF) by 42.11/min, more than twice the improvement achieved with either dose of FP alone. SM/FP250 also resulted in more symptom-free days and nights (P < 0.002) and days and nights with no relief medication (P < 0.001). The number of severe exacerbations was low: 3, 6 and 8% in the SM/FP250, low- and high-dose FP groups, respectively This study confirms that adding salmeterol to low-dose inhaled FP offers greater improvements than either maintaining or doubling the dose of FP Significant benefit was gained from adding salmeterol in a group of patients who appeared to have been at the top of their steroid dose-response curve receiving FP250,There was no evidence of tolerance and a low incidence of exacerbations in all treatment groups. (C) 2003 Published by Elsevier Science Ltd.