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Treatment helped reduce dose of inhaled corticosteroids while maintaining asthma control

ercent while maintaining asthma control in patients requiring fluticasone propionate (FP) 250 mcg twice daily for asthma stability. This equivalence study also indicated that even though patients had stable asthma at randomization, there were numerical improvements in pulmonary function, percent of days with no asthma symptoms and need for supplemental albuterol in patients taking Advair Diskus 100/50 BID compared with patients taking FP 250 mcg BID. Confidence intervals for these clinical measures fell within the pre-defined margins of equivalence, demonstrating equivalence between treatment groups. Study results follow:

*p <0.045 Advair vs. FP

"Advair 100/50 BID allowed patients currently using higher doses of inhaled corticosteroids alone to reduce their dose of inhaled corticosteroids, as treatment guidelines recommend, while maintaining overall asthma control," said Steven A. Sahn, MD, professor of pulmonary and critical care medicine at the Medical University of South Carolina and one of the study's lead investigators. "The fact that Advair has both an inhaled corticosteroid and an inhaled long-acting bronchodilator in the same device made this a convenient treatment option as well."

The study was a randomized, double blind, double dummy, parallel group trial. Adolescent and adult patients, ages 12 and over, using medium doses of inhaled corticosteroids (FP 220 mcg BID or equivalent) had to complete two run-in periods prior to randomization. In the first run-in period, patients had to show clinical asthma instability on FP 100 mcg BID, followed by clinical stability on FP 250 mcg during the second run-in period. Thus, unlike other inhaled corticosteroid-sparing trials, the minimum effective dose of inhaled corticosteroids was established in all patients prior to randomization, and only patients who required FP 250 mcg BID for asthma stability were allowed to continue. Randomized patients had a mean baseline FEV1 (a measure
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6-Nov-2002


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