A Cochrane review [Abstract] 1 included 43 studies with a total of 2801 subjects. In non-oral steroid treated asthmatics, budesonide led to significant improvements in a number of measures of airway function. All high methdological quality studies demonstrated significant improvements compared to placebo. Risk of trial withdrawal due to asthma exacerbation was lower with budesonide compared to placebo (RR 0.17, 95% CI 0.09 to 0.33). Doses of 500-800 mcg/d appeared to have slightly larger effect sizes than lower doses, but no advantage for higher doses were apparent.
Another Cochrane review 2 (abstract , review [Abstract]) included 24 studies with a total of 3907 subjects. In mild to moderately severe asthma no clinically worthwhile differences in FEV1, morning PEFR, symptom scores or rescue beta2 agonist use were apparent across a dose range of 200-1600 mcg/d. However, in moderate to severe asthma there was a significant reduction in the likelihood of trial withdrawal due to asthma exacerbation with 800 mcg/d compared to 200 mcg/d (RR 3.93, 95% CI 1.4 to 10.9). In a single study in patients receiving oral corticosteroids, high dose budesonide (1600 mcg/d compared to 200 mcg/d) improved FEV1 and morning PEFR.
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