A MULTICENTER, PLACEBO-CONTROLLED STUDY OF TWICE-DAILY TRIAMCINOLONE ACETONIDE (800 MU-G PER DAY) FOR THE TREATMENT OF PATIENTS WITH MILD-TO-MODERATE ASTHMA

Background: National and international guidelines recommend the use of inhaled antiinflammatory medications in patients with all but the mil dest forms of asthma. Twice daily dosing may increase compliance with therapy. Objective: We sought to evaluate the safety and efficacy of 4 00 mu g twice daily triamcinolone acetonide (TAA) compared with placeb o in adult patients with mild-to-moderate asthma who were poorly contr olled by beta(2)-agonist therapy.Methods: We performed a multicenter, randomized, double-blind, placebo-controlled study, including a screen ing visit, a 7- to 21-day pretreatment baseline phase, and a 6-week do uble-blind treatment phase. Efficacy was measured by weekly spirometry and daily diary recordings of peak flow rates, asthma symptom scores, and albuterol use. Eligible patients used albuterol four or more time s per day, had total asthma symptom scores of 15 or greater (possible total, 60) over 5 of 7 baseline days, and had FEV1 measurements of 60% of predicted value or greater. Results: One hundred twenty-one patien ts were randomized to treatment. TAA was superior to placebo for all e fficacy measures, with significant improvements in asthma symptoms, al buterol use, morning and evening peak flow rates, and forced vital cap acity evident at Treatment Week 1. Significant improvements in other p ulmonary function measurements were observed after 2 or more weeks. Al l efficacy variables improved progressively throughout the study. Conc lusions: Twice daily TAA (400 mu g) decreased asthma symptoms and impr oved lung function in patients with mild-to-moderate asthma compared w ith placebo. Therapeutic benefit was evident within 1 week and increas ed throughout treatment.