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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, chosen markers of inflammation, induction of regulatory lymphocytes, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SIT in children with asthma.
Specific immunotherapy is the only one causal treatment method of atopic diseases including bronchial asthma in children.
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, chosen markers of inflammation, induction of regulatory lymphocytes, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SIT in children with asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | subcutaneous immunotherapy (House Dust Mites) |
|
| 2 | Placebo Comparator | placebo of subcutaneous immunotherapy (House Dust Mites) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| subcutaneous immunotherapy (House Dust Mites) | Biological | subcutaneous immunotherapy (House Dust Mites) |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical symptoms, reliever drugs usage, controller medication usage, quality of life, lung function, chosen markers of inflammation (ECP, specific IgE, specific IgG) induction of regulatory lymphocytes (Treg) - Foxp3 mRNA expression | baseline (first visit), after 3 months (second visit), 12 months (third visit), 24 months (fourth visit) |
| Measure | Description | Time Frame |
|---|---|---|
| bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SIT (skin prick tests) | after 24 months from first visit (fourth visit) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dorota Jurałowicz, MD | Contact | 00 48 42 6895972 | alergol@kopernik.lodz.pl |
| Name | Affiliation | Role |
|---|---|---|
| Iwona Stelmach, MD, PhD, Prof | Department of Pediatrics and Allergy, Medical University of Lodz, Poland | Study Chair |
| Dorota Jurałowicz, MD | Department of Pediatrics and Allergy, Medical University of Lodz, Poland |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics and Allergy, Medical University of Lodz | 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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| placebo of subcutaneous immunotherapy (House Dust Mites) | Other | placebo of subcutaneous immunotherapy (House Dust Mites) |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |