Effect of Different Anti-Asthmatic Treatments on Lung Function and on Exercise-Induced Bronchoconstriction in Children With Asthma
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|ClinicalTrials.gov Identifier: NCT00490243|
Recruitment Status : Completed
First Posted : June 22, 2007
Last Update Posted : June 28, 2007
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: budesonide and montelukast Drug: budesonide and formoterol Drug: montelukast Drug: budesonide Drug: placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Study Start Date :||July 2003|
|Actual Study Completion Date :||October 2006|
- FEF25-75%, Rint, sRaw, FEV1, PEFR, maximum percentage fall in FEV1 after exercise test, the area under the curve (AUC) for the FEV1 values over the 20-min period from exercise [ Time Frame: baseline (second visit) and after 4 weeks of treatment (third visit) ]
- symptoms score [ Time Frame: baseline (second visit) and after 4 weeks of treatment (third visit) ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490243
|Department of Pediatrics and Allergy, Medical University of Lodz, Poland|
|Lodz, Poland, 93-513|
|Principal Investigator:||Tomasz Grzelewski, MD, PhD||Department of Pediatrics and Allergy, Medical University of Lodz, Poland|
|Study Chair:||Iwona Stelmach, MD, PhD, Prof||Department of Pediatrics and Allergy, Medical University of Lodz, Poland|