Effect of inhaled beclomethasone dipropionate and budesonide dry powder on pulmonary function and serum eosinophil cationic protein in adult asthmatics

The aim of this study was to determine whether the effects of inhaled beclomethasone dipropionate and budesonide dry powder on pulmonary function correlate with those on measurement of serum eosinophil cationic protein (sECP). Thirty-two asthmatic adults in a stable phase, treated daily with 1,000 mu g beclomethasone dipropionate metered-dose inhaler, completed a P-week wash-out period and were then randomized to receive a 200 mu g/dose q.i.d. of either drug, over an 8-week period. Pulmonary function tests (FEV1, FVC, PEFR, FEF25-75% and MEF50) were measured at study entry, before and after every 2 weeks of treatment, while PEFR (morning and evening), symptom scores and salbutamol use PRN were recorded daily on a diary card, sECP was measured at baseline and after 4 and 8 weeks of treatment. Safety variables included adverse reactions, morning serum cortisol and vital signs (heart rate and blood pressure). FEV1, FVC, PEFR, FEF25-75% , MEF50 and morning PEFR significantly increased (p <0.05) over baseline in the beclomethasone group, while only FEV1 at week 6 and evening PEFR significantly increased (p <0.05) in the budesonide group; no significant differences between groups were reported sECP significantly decreased (p <0.01) in the beclomethasone group at week 4 and 8 (p <0.05 between groups). Evidence of statistically significant negative correlation between the FEV1 percent predicted and sECP was assessed at baseline (correlation coefficient r = -0.60, p <0.05) in the total patient sample, and in the results, expressed as percent change over baseline, obtained at both week 4 and 8 (p <0.01). A significant decrease in salbutamol use PRN symptom score and number of daily bronchospasm attacks was also reported in the beclomethasone group (p <0.05). No adverse reactions or relevant changes in morning cortisol and vital signs were reported in either group. It was concluded that sECP proved to be a reliable marker for monitoring inflammatory events in asthma; inhaled beclomethasone dipropionate dry powder was at least as effective as budesonide in improving lung function and the underlying asthma inflammation.