A randomized, double-blind trial of the effect of anti-asthma treatment on lung function in children with asthma

Abstract Background Pulmonary function tests (PFTs) and especially spirometry measures are useful tools in evaluating early response to treatment of asthma in children mainly due to their worldwide availability. The aim of our study was to determine the effects of anti-asthma treatment in children, equally on FEV 1 , FEF25–75%, R int and SR aw values. Methods Children 6–18 years of age with moderate atopic asthma were randomized to 4-week, placebo-controlled, double-blind trial. Patients were randomly allocated to receive 200 μg budesonide (B) ( n =29), 5 or 10 mg (according to age) montelukast (M) ( n =29), 200 μg B+5 or 10 mg M ( n =29), 200 μg B+9 μg formoterol (F) ( n =29) or placebo ( n =27). FEV 1, FEF25–75%, R int , SR aw were measured before and after treatment. Results R int , SR aw , FEV 1 improved significantly in all active treatment groups while FEF25–75% improved significantly only in BM group and M group. Combination therapy, showed significantly greater effects on R int than monotherapy: BM group compared to B group ( P =0.01) and M group ( P =0.03) and BF group compared to B group ( P =0.01) and M group ( P =0.04). Conclusion This study shows that using single parameter for monitoring asthma can be misleading. Using combination of lung function techniques provides better assessment of treatment. Results of our study confirm this hypothesis. The best effect on large and small airways was achieved with combined anti-inflammatory therapy.