COMPARATIVE CLINICAL-STUDY OF INHALED BECLOMETHASONE DIPROPIONATE ANDTRIAMCINOLONE ACETONIDE IN PERSISTENT ASTHMA

At this time, no placebo-controlled studies in the clinical literature compare the efficacy and safety of the most widely prescribed oral in haled corticosteroids when dosed at their recommended daily doses. Thi s study compared the efficacy and safety of beclomethasone dipropionat e (BDP) 336 mu g/day administered by metered dose inhaler (MDI) alone, and triamcinolone acetonide (TA) 800 mu g/day by MDI with a built-in tube extender in adults with persistent asthma. Methods: This 56-day, randomized, double-blind, double-dummy, placebo-controlled, multicente r trial was conducted in 328 adults with mild to moderately severe ast hma (FEV1 50% to 90% of predicted while maintained on inhaled corticos teroids). Patients were seen at a baseline visit and on study days 28 and 56. Efficacy variables included pulmonary function tests, physicia n and patient assessments of asthma condition, and use of rescue medic ation. Results: Statistically significant improvements from baseline i n most efficacy measures were demonstrated for both active treatments versus placebo, and with the following exception were the same between active treatments: mean increase in FEV1 in the beclomethasone diprop ionate group was statistically significantly greater than in the triam cinolone acetonide group on day 28. Throughout the study, BDP was stat istically superior to TA with respect to mean change from baseline in total asthma symptom scores and for 3 of 8 weeks in reducing the mean average weekly use of rescue albuterol (the two active treatments were comparable for this variable at all other time points). Beclomethason e dipropionate and TA were comparable in safety. Conclusion: In adult patients with mild to moderately severe persistent asthma, treatment w ith BDP consistently conferred greater improvement from baseline in me an FEV1 than TA. This difference achieved statistical significance aft er 28 days of therapy but was not maintained to endpoint. Decreases in overall asthma symptom scores and in the use of rescue albuterol were statistically significantly greater for the BDP group compared with t he TA group. Based on these findings, we conclude that BDP is at least as effective as TA in the treatment of persistent asthma in adults, a nd judged by some measures, may be superior.