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

Pulm Pharmacol Ther. 2007;20(6):691-700. doi: 10.1016/j.pupt.2006.08.003. Epub 2006 Sep 14.


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 microg budesonide (B) (n=29), 5 or 10 mg (according to age) montelukast (M) (n=29), 200 microg B + 5 or 10 mg M (n=29), 200 microg B + 9 microg 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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetates / therapeutic use
  • Adolescent
  • Airway Resistance / drug effects
  • Anti-Asthmatic Agents / therapeutic use*
  • Asthma / drug therapy*
  • Bronchodilator Agents / therapeutic use*
  • Budesonide / therapeutic use
  • Child
  • Cyclopropanes
  • Double-Blind Method
  • Drug Therapy, Combination
  • Ethanolamines / therapeutic use
  • Female
  • Forced Expiratory Volume / drug effects
  • Formoterol Fumarate
  • Humans
  • Male
  • Maximal Midexpiratory Flow Rate / drug effects
  • Plethysmography, Whole Body
  • Quinolines / therapeutic use
  • Respiratory Function Tests / methods
  • Sulfides


  • Acetates
  • Anti-Asthmatic Agents
  • Bronchodilator Agents
  • Cyclopropanes
  • Ethanolamines
  • Quinolines
  • Sulfides
  • Budesonide
  • montelukast
  • Formoterol Fumarate