NCT00490243

Effect of Different Anti-Asthmatic Treatments on Lung Function and on Exercise-Induced Bronchoconstriction in Children With Asthma

A Randomized, Double-Blind Trial of the Effect of Different Anti-Asthmatic Treatments on Lung Function and on Exercise-Induced Bronchoconstriction in Children With Asthma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Medical University of Lodz · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The present study was conducted to determine the effects of four week treatment with budesonide, montelukast, budesonide with montelukast and budesonide with formoterol in children with atopic asthma on lung function: forced expiratory volume in one second, mid-expiratory flow, peak expiratory flow rate, resistance by the interrupter technique, plethysmographic specific airway resistance, exercise-induced bronchial hyperreactivity and clinical symptoms.

Detailed description

Asthma is one of the most common chronic disease worldwide, imposing a substantial social burden on children. Allergic inflammation is responsible for all clinical symptoms of asthma. The effects of allergic inflammation are: bronchial muscle constriction, excessive mucus production, and edema of mucosa, all elements of "asthmatic triad" causing bronchial obturation. Normal lung function is one of the goals of asthma management. In most of the studies the effect of monotherapy on the symptom scores, lung function parameters and bronchial hyperreactivity was assessed. The present study was conducted to determine the effects of four week treatment with budesonide, montelukast, budesonide with montelukast and budesonide with formoterol in children with atopic asthma on lung function: forced expiratory volume in one second, mid-expiratory flow, peak expiratory flow rate, resistance by the interrupter technique, plethysmographic specific airway resistance, exercise-induced bronchial hyperreactivity and clinical symptoms.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	budesonide and montelukast
DRUG	budesonide and formoterol
DRUG	montelukast
DRUG	budesonide
DRUG	placebo

Timeline

• Start date: 2003-07-01
• Completion: 2006-10-01
• First posted: 2007-06-22
• Last updated: 2007-06-28

Locations

1 site across 1 country: Poland