A COMPARISON OF TRIAMCINOLONE ACETONIDE MDI WITH A BUILT-IN TUBE EXTENDER AND BECLOMETHASONE DIPROPIONATE MDI IN ADULT ASTHMATICS

Study objective: In this study, the efficacy and safety of triamcinolo ne acetonide (TA) metered-dose inhaler with a built-in tube extender a nd beclomethasone dipropionate (BDP) metered-dose inhaler without a sp acer device were compared. Both treatments were dosed at their most co mmonly used daily doses (within labeling). Design: A 56-day, randomize d, double-blind, double-dummy placebo-controlled trial. Setting: Seven teen asthma/allergy centers. Patients: We enrolled 339 patients 18 to 65 years of age, with a documented history of bronchial asthma (FEV1, 50 to 90% of predicted value) for greater than or equal to 2 years who required inhaled corticosteroid therapy. Interventions: Patients were randomized to receive BDP 336 mu g/d (4 puffs bid) plus TA placebo (4 puffs bid), TA 800 mu g/d (4 puffs bid) plus BDP placebo (4 puffs bid ), or TA and BDP placebos (4 puffs of each bid). The only other asthma medication permitted was inhaled albuterol that was used as a rescue medication. All medications were administered via the closed-mouth inh alation technique. Measurements and results: At 8 weeks and at study e nd point, both active treatment groups had statistically significant a nd comparable improvements in FEV1 relative to baseline, and statistic ally significant increases relative to placebo. At study end point, im provements in forced expiratory flow (FEF25-75%), clinic peak expirato ry flow (PEFR), and FYC were statistically significant for the active treatment groups compared with placebo. At end point, the mean differe nce between BDP and TA for mean change in FEV1 from baseline in the ef ficacy population was 0.02 and the 95% confidence interval was -0.11, 0.15. Asthma symptoms recorded at clinic visits showed statistically s ignificant improvements for the BDP and TA groups compared with the pl acebo group. Treatment-related adverse events occurred with similar fr equency in all patient groups-25.5% of placebo-treated patients, 22.3% of BDP patients, and 20.4% of TA patients. The incidence of oropharyn geal adverse events, including cough, thrush, and dysphonia, was not s tatistically different between the two active treatment groups. Conclu sion: In this randomized, double-blind, placebo-controlled study of ad ult asthmatics treated with either BDP without a spacer or TA with its built-in tube extender, BDP and TA were comparable in efficacy as mea sured by FEV1 and other pulmonary function tests, and by improvement i n asthma symptoms. Both active treatments were significantly more effe ctive than placebo. All treatment groups were comparable in safety as measured by the incidence of adverse events.