A RANDOMIZED DOUBLE-BLIND-STUDY COMPARING INHALED BECLOMETHASONE WITHLONG-ACTING THEOPHYLLINE FOR THE FIRST-LINE TREATMENT OF MODERATE ASTHMA

Although current international guidelines recommend use of inhaled cor ticosteroids for the first-line treatment of mild persistent asthma, l ong-acting theophylline is a reasonable alternative. Beclomethasone di propionate (BDP) is appropriate for mild to moderate asthma requiring symptomatic treatment on a daily basis. A multicenter, randomized, dou ble-blind, double-dummy trial was conducted to compare the efficacy an d safety of BDP in a dose of 1000 mu g per day and of oral sustained-r elease theophylline in a dose of 600 mg per day. Most study patients w ere from private practices. After a three-day wash-out period, 227 pat ients with moderate asthma were treated for eight weeks. Mean age was 42.3 years. Patients were evaluated after four and eight weeks. The st atistical analysis included 194 patients. At completion of the eight-w eek treatment, improvements in FEV(1) and FEF(25-75) were significantl y greater in the BDP group than in the theophylline group (p < 0.01 an d p < 0.001, respectively). The number of episodes of respiratory disc omfort or asthma attacks decreased by 37% in the BDP group versus 11% in the theophylline group. Decreases in use of rescue bronchodilator m edications were similar in the two groups. as were numbers of adverse events. Self-evaluated visual analog scale scores for respiratory comf ort were higher in the BDP group (p < 0.05). These data demonstrate th at both treatments were effective and safe but that clinical and funct ional improvements were greater in the BDP group, further supporting u se of inhaled corticosteroids for first-line therapy in moderate asthm a as recommended by international guidelines.