CLINICAL TRIAL
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JOURNAL ARTICLE
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The comparison of the effects of fluticasone propionate and budesonide on clinical indices and on bone mineral density in the asthmatic patients: a one year treatment study.

BACKGROUND: it is well accepted that the inhaled administration of steroids is efficacious and has fewer side effects than the systemic use. Among them fluticasone propionate (FP) has been said to cause the similar antiasthma effect without unfavorable side effect at half the dose of the other ICS. The aim of the study was to compare the effects of FP 500 microg/day and budesonide (BUD) 800 microg/day as a pressurized metered dose inhaler (pMDI) for one year on clinical indices determined by FEV1 and diurnal variation of PEFR (peak expiratory flow rates) and on laboratory indices determined by serum cortisol and bone mineral density (BMD).

METHODS: a total of 30 nonsmoking mild to moderate asthmatic patients were recruited the study. 15 patients were given 800 microg/day BUD and 15 patients were given 500 microg/day FP as a pMDI. BMD measurements were done with dual energy X-ray absorbtiometry (DEXA) before and after the treatment at the lumbar area of the spine (L1-4) and left hip (trocanter major, neck of femur, intertrocanteric region and Ward's triangle). 10 patients of BUD group and 13 of FP group completed the study. After a year of treatment period, patients were compared on the basis of clinical indices (FEV1 and variability of PEFR), on serum cortisol levels and on BMD in both groups.

RESULTS: after the treatment, variability of PEFR (in BUD group p < 0,01, in FP group p < 0,001) and FEV1 (in BUD group p < 0,05, in FP group p < 0,05) were both improved in the groups. Serum cortisol levels and BMD of the patients in both groups were not changed significantly (p > 0,05).

CONCLUSIONS: the results suggested that FP 500 microg/d and BUD 800 microg/d as a pMDI results in a similar antiasthma effect without causing any adverse effect on BMD in mild and moderate asthmatics after one year treatment period.

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