Double-Blind Study of Inhaled Salbutamol Versus Salbutamol Plus High-Dose Flunisolide in Exacerbation of Bronchial Asthma: A Pilot Study

Abstract

Objective

The effectiveness of inhaled flunisolide, in acute intermittent or mild persistent re-exacerbation of asthma.

Design

In a double-blind, randomized, controlled trial, the effects of high-dose flunisolide (600 μg three times daily for 15 days) plus salbutamol (1250 μg plus 2 mL of saline), via an electric nebulizer, were compared with the effect of 1250 μg of salbutamol plus 2 mL of saline and 1 mL of dummy drops.

Setting

The study was performed at the Children's Outpatient Department of the Pediatric Department of the University of Catania.

Patients

Thirty children aged 5–14 years (mean, 9 ± 2.5 years) with exacerbation of asthma. The patients had a decrease of 80% or more of their Fev₁ namely, forced vital capacity in the first second, and of 70% or more of their Fev_25-75 namely, forced vital capacity from 25 to 75 seconds, with respect to normal values at entry into the study. Two patients in the group treated with salbutamol voluntarily withdrew from the study and, therefore, the study involved a total of 28 children.

Results

Both treatments were effective in controlling symptoms (p =.01) and in producing a statistically significant improvement in respiratory function tests (p values from.05 to.01). In the flunisolide group a statistically significant difference was recognized for symptoms from the diary (p <.05) and in the percentage variation from the basal value of PEF (peak expiratory flow) in the morning of the 12th day of the study. In this group symptoms from the diary and the PEF, show a better "trend."

Conclusion

High-dose flunisolide seems to be beneficial in asthmatic exacerbations.