A double-blind comparison of inhaled budesonide, long-acting theophylline, and their combination in treatment of nocturnal asthma.

In 61 patients with nocturnal asthma, the effects of budesonide, an inhaled steroid (Pulmicort; 200 micrograms twice daily), long-acting theophylline (Theodur; 200 mg twice daily), and their combination were compared. After a 2-week placebo run-in period, the patients were entered into double-blind, crossover periods of 3 weeks. Patients were allowed to use inhaled beta 2-agonists as required throughout the study. Morning and evening peak expiratory flow rate (PEFR) (percentage of predicted normal +/- SEM) was significantly higher during the budesonide (morning 77 +/- 1%; evening 80 +/- 1%) and combination therapy (morning 79 +/- 1%; evening 81 +/- 1%) than the theophylline treatment (morning 74 +/- 1%; evening 76 +/- 1%; P < 0.01, respectively). Significantly fewer sleep disturbances and fewer nighttime inhalations of beta 2-agonists were required during budesonide and combination therapy than theophylline treatment. No statistically significant differences were seen between combined therapy and budesonide alone. Budesonide, an inhaled steroid, was significantly better than the bronchodilator, theophylline, in controlling nocturnal asthma, but no additional improvement in efficacy was seen when the drugs were used in combination.