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The aim of the study is to assess the effect of specific immunotherapy (SIT) to dust mites on clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function, bronchial hyperreactivity with methacholine, and presence and type of allergy after three years of SIT in children with asthma.
According to Global Initiative for Asthma treatment of asthma is based on avoidance of allergens, pharmacological treatment, and specific immunotherapy.
The aim of the study is to assess the effect of specific immunotherapy (SIT) to dust mites on clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function, bronchial hyperreactivity with methacholine, and presence and type of allergy after three years of SIT in children with asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | No Intervention | no intevention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novo Helisen Depot, Phostal | Biological | subcutaneous immunotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function | baseline (first visit), 12 months (second visit), 24 months (third visit), 36 months (fourth visit) |
| Measure | Description | Time Frame |
|---|---|---|
| bronchial hyperreactivity with methacholine, and presence and type of allergy after tree years of SIT in children with asthma. | after 36 months (fourth visit) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agnieszka Sobocińska, MD | Contact | 00 48 42 6895972 | alergol@kopernik.lodz.pl |
| Name | Affiliation | Role |
|---|---|---|
| Agnieszka Sobocińska, MD | Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland | Principal Investigator |
| Iwona Stelmach, MD PhD Prof | Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics and Allergy, Medical University of Lodz, Poland | Recruiting | Lodz | 93-513 | Poland |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C014135 | Novo-Helisen Depot |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |