Effects of long-term treatment with inhaled cromoglycate and budesonide on bronchial hyperresponsiveness in patients with allergic asthma.

Twenty two allergic patients with bronchial asthma completed this study. Effects of long-term treatment with inhaled cromoglycate 4 x 2 mg.day-1 were compared to the effects of inhaled budesonide 4 x 0.1 mg.day-1 on symptoms, additional beta 2-agonist use, lung function and bronchial hyperresponsiveness measured by the provocation concentration of histamine producing a 20% fall in forced expiratory volume in one second (FEV1) (PC20 histamine) and exercise-induced fall in FEV1. The study was carried out in a double-blind way with a randomized crossover design using a double-dummy technique. After a single-blind placebo period, the two active treatment periods of 6 weeks were separated by a single-blind placebo period. Symptom score and beta 2-agonist use decreased during both active treatment periods, which showed no mutual differences. Morning and evening peak expiratory flow rates were significantly higher during treatment with budesonide versus placebo (p less than 0.01 and p less than 0.001), and also versus cromoglycate (p less than 0.02 and p less than 0.05). FEV1 showed improvement after a 6 week treatment with budesonide versus placebo (p less than 0.05), although there was no significant difference between the two active treatments. PC20 histamine did not change during treatment with cromoglycate. Budesonide showed a significant increase in PC20 histamine versus placebo (p less than 0.05) and was marginally significantly better than cromoglycate (p = 0.05). Exercise-induced fall in FEV1 was not changed by cromoglycate, but improved significantly during budesonide in comparison with placebo (p less than 0.01) and also with cromoglycate (p less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes