COMPARISON OF ADDITION OF SALMETEROL TO INHALED STEROIDS WITH DOUBLING OF THE DOSE OF INHALED STEROIDS

A study was done to compare the efficacy and safety of the coprescript ion of salmeteros 50 mu g twice daily or 100 mu g twice daily with bec lomethasone dipropionate (BDP) 500 mu g twice daily (SALM 50 and SALM 100) with BDP 1,000 mu g twice daily (BDP 1,000) in patients with asth ma not controlled by BDP 500 mu g twice daily (or the equivalent). Fol lowing a run-in period, 738 patients at 72 centers were randomized to treatment for 24 wk in a double-blind, parallel-group study during whi ch they maintained a daily record of peak expiratory flow rates (PEFRs ) and symptom scores. At about 40 of the centers, bronchial hyperrespo nsiveness (BHR) to histamine was measured during and at 3 and 14 d aft er stopping treatment. Both groups taking salmeterol showed an improve ment of more than 45 L/min in their morning PEFR and 30 L/min in their evening PEFR, compared with respective improvements of 16 L/min and 6 L/min in the group taking BDP 1,000. Both the SALM 50 and SALM 100 gr oups had a significantly increased percentage of symptom-free and resc ue-free days and nights compared with the BDP 1,000 group, and there w as no difference between the two salmeterol groups. None of the treatm ents altered BHR. Exacerbation rates did not differ among the three gr oups. We conclude that in this selected group of symptomatic patients taking BDP 500 mu g twice daily, the addition of salmeterol provides b etter improvement in lung function and symptom control, without alteri ng BHR or increasing exacerbation rates, than does doubling the dose o f BDP.