Purpose of the Study
To assess the effects of long-term treatment with inhaled budesonide (BUD) on total body bone mineral density (BMD), total body bone mineral capacity (BMC), total body calcium (TBC), and body composition in children with asthma.
One hundred fifty-seven asthmatic children treated with inhaled BUD at a mean daily dose of 504 μg (range, 189–1322 μg) for 3 to 6 years (mean, 4.5 years).
Dual energy x-ray absorptiometry (DEXA Scan) was performed and measurements compared with those of 111 age-matched children also suffering from asthma but who had never been treated with exogenous corticosteroids for more than 14 days (control group).
There were no statistically significant differences between the two groups in BMD (BUD = 0.915 g/cm2, controls = 0.917 g/cm2), BMC (BUD = 1378 g, controls = 1367 g), TBC (BUD = 524 g, controls = 519 g), or body composition (lean body weight = 27 600 g [BUD] and 26 923 g [control], % body fat = 20.1% [BUD] and 20.3% [control]). There was no correlation between any of these parameters and duration of treatment, accumulated or current dose of budesonide.
Three to 6 years of treatment with inhaled BUD at an average daily dose of 504 μg has no adverse effect on total BMD, total BMC, TBC, or body composition in children with chronic asthma.
This study is reassuring in providing much needed information on relatively safe doses of an inhaled steroid, in this case budesonide. The investigators conducted this study under open-label conditions in a nonrandomized manner. They took several steps to monitor adherence to the treatment program and compared their results with a suitable control group. Similar information is needed for the other inhaled steroids and their respective delivery devices, especially those recommended in the treatment of asthmatic children.