DOUBLE-BLIND-STUDY OF INHALED SALBUTAMOL VERSUS SALBUTAMOL PLUS HIGH-DOSE FLUNISOLIDE IN EXACERBATION OF BRONCHIAL-ASTHMA - A PILOT-STUDY

Objective: The effectiveness of inhaled flunisolide, in acute intermit tent or mild persistent re-exacerbation of asthma. Design: In a double -blind, randomized, controlled trial, the effects of high-dose fluniso lide (600 mu g three times daily for 15 days) plus salbutamol (1250 mu g plus 2 mt of saline), via an electric nebulizer, were compared with the effect of 1250 mu g of salbutamol plus 2 mt of saline and 1 mt of dummy drops.Setting: The study was performed at the Children's Outpat ient Department of the Pediatric Department of the University of Catan ia. Patients: Thirty children aged 5-14 years (mean, 9 +/- 2.5 years) with exacerbation of asthma. The patients had a decrease of 80% or mor e of their Fev(1) namely, forced vital capacity in the first second, a nd of 70% or more of their Fev(25-75) namely, forced vital capacity fr om 25 to 75 seconds, with respect to normal values at entry into the s tudy. Two patients in the group treated with salbutamol voluntarily wi thdrew from the study and, therefore, the study involved a total of 28 children. Results: Both treatments were effective in controlling symp toms (p = .01) and in producing a statistically significant improvemen t in respiratory function tests Or values from .05 to .01). In the flu nisolide group a statistically significant difference was recognized f or symptoms from the diary (p < .05) and in the percentage variation f rom the basal value of PEP (peak expiratory flow) in the morning of th e 12th day of the study. In this group symptoms from the diary and the PEP, show a better ''trend.'' Conclusion: High-dose flunisolide seems to be beneficial in asthmatic exacerbations.