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

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 FEV1, FEF25-75%, R-int and SRaw 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 mu g budesonide (B) (n = 29), 5 or 10 mg (according to age) montelukast (M) (n = 29), 200 mu g B + 5 or 10 mg M (n = 29), 200 mu g B + 9 mu g formoterol (F) (n = 29) or placebo (n = 27). FEV1, FEF25-75%, R-int, SRaw were measured before and after treatment. Results: R-int, SRaw, FEV1 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. (C) 2006 Elsevier Ltd. All rights reserved.