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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| budesonide and montelukast | Drug | |||
| budesonide and formoterol | Drug | |||
| montelukast | Drug | |||
| budesonide | Drug | |||
| placebo | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline (second visit) and after 4 weeks of treatment (third visit) |
| Measure | Description | Time Frame |
|---|---|---|
| symptoms score | baseline (second visit) and after 4 weeks of treatment (third visit) |
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Inclusion Criteria:
Exclusion Criteria:
Study exclusions included:
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| Name | Affiliation | Role |
|---|---|---|
| Tomasz Grzelewski, MD, PhD | Department of Pediatrics and Allergy, Medical University of Lodz, Poland | Principal Investigator |
| Iwona Stelmach, MD, PhD, Prof | Department of Pediatrics and Allergy, Medical University of Lodz, Poland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics and Allergy, Medical University of Lodz, Poland | Lodz | 93-513 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17046300 | Result | Stelmach I, Grzelewski T, Bobrowska-Korzeniowska M, Stelmach P, Kuna P. 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| C093875 | montelukast |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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