Inhaled budesonide at different doses for chronic asthma (Cochrane Review)

A substantive amendment to this systematic review was last made on 04 December 1999. Cochrane reviews are regularly checked and updated if necessary.

Background: Inhaled budesonide (BUD) is available in a range of doses for treating chronic asthma.

Objectives: To assess the efficacy and safety of budesonide at different doses in order to establish whether a clinically significant dose response profile exists.

Search strategy: A search was carried out for Controlled Clinical Trials using the Cochrane Airways Group trial register.

Selection criteria: Randomised trials in children and adults comparing one dose of budesonide to a second dose in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and methodological quality.

Data collection and analysis: One reviewer extracted data; authors were contacted to clarify missing information. Quantitative analyses where undertaken using Review Manager 4.0.4 with MetaView 3.1.

Main results: 24 studies met the inclusion for the review (3907 subjects). In non-oral steroid treated, 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 a significant reduction in the likelihood of trial withdrawal due to asthma exacerbation was apparent when treating patients with BUD 800 mcg/d compared to 200 mcg/d: Relative Risk 3.93 (95% confidence interval, 1.4 to 10.9). This result was weighted largely by a single, large, high quality RCT. In severe asthma significant improvements favouring high dose BUD (1600 mcg/d) over low dose (200 mcg/d) were apparent for FEV1 but not morning PEFR. This finding was based on two large RCTs of good quality. In oral steroid treated asthmatics no dose dependent oral steroid sparing effect was apparent for BUD 1600 mcg/d v 800 or 400 mcg/d. Statistically significant, dose dependent suppression of 24 hour urinary free cortisol excretion and serum cortisol post synthetic ACTH infusion over the dose range 800-3200 mcg/d was apparent but the clinical significance of these findings is unclear.

Reviewers' conclusions: Budesonide exhibits a significant dose response effect between low and high dose for improvement in FEV1 in severe asthma and reduction of exacerbations in moderate to severe asthma. No significant dose dependent improvements in FEV1, PEFR or symptoms are evident in non-oral steroid treated asthmatics with mild to moderate disease. Dose dependent alterations in sensitive measures of hypothalamic-pituitary-adrenal function were evident but the clinical significance of these changes is unclear.

Citation: Adams N, Bestall J, Jones P. Inhaled budesonide at different doses for chronic asthma (Cochrane Review). In: The Cochrane Library, Issue 3, 2003. Oxford: Update Software.

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This is an abstract of a regularly updated, systematic review prepared and maintained by the Cochrane Collaboration. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).

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File Reference: AB003271.htm