Concurrent use of salmeterol with inhaled corticosteroids is more effective than inhaled corticosteroid dose increases

This randomized double-blind, parallel, multi-center study was designed to determine whether the addition of salmeterol to existing inhaled corticosteroid therapy provides greater therapeutic benefit than doubling the dose of inhaled corticosteroids in symptomatic patients with asthma. A total of 514 adults were randomized to either beclomethasone 168 mu g plus salmeterol 42 mu g twice daily or beclomethasone 336 mu g twice daily for 24 weeks. Both treatments resulted in significantly improved symptom control and increased pulmonary function. However, beclomethasone pills salmeterol provided greater improvements than doubling the dose of beclomethasone (p less than or equal to 0.05) in FEV, and in daily-recorded measurements of morning (38 L/minute versus 20 L/minute after treatment with higher dose beclomethasone) and evening peak expiratory flow, asthma symptom scores, symptom-fi-ee days, supplemental albuterol use, and days and nights not requiring albuterol. There were no sigificant differences between treatment groups in the number of patients with abnormal response to corticotropin stimulation at Treatment Week 24. Na treatment differences in asthma exacerbation and adverse event frequency rates were seen. Beclomethasone 168 mu g piles salmeterol 42 mu g administered twice daily was superior to beclomethasone 336 mu g taken twice daily in patients symptomatic on beclomethasone 168 mu g, with no added safety risks.