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There is mounting evidence that successful allergen immunotherapy (SIT) functions through the induction of different subset of Treg including Foxp3 positive cells, therefore additional strategies to enhance this property are highly attractive. Based on previous findings we assumed that combine allergen immunotherapy with non-specific treatments such as glucocorticosteroids and vitamin D3 as well as montelukast sodium treatment might enhanced allergen tolerance induction and improved clinical effectiveness of allergen-specific immunotherapy
There is mounting evidence that successful allergen immunotherapy (SIT) functions through the induction of different subset of Treg including Foxp3 positive cells, therefore additional strategies to enhance this property are highly attractive. Since corticosteroids directly induce the development of an IL-10-synthesizing regulatory T-cell population (Tr1) and this effect can be greatly increased with vitamin D3 treatment we , we assumed that combine allergen immunotherapy with non-specific treatments such as glucocorticosteroids and vitamin D3 as well as montelukast sodium treatment might enhanced allergen tolerance induction and improved clinical effectiveness of allergen-specific immunotherapy, therefore we conducted the stud comparing the effect of glucocorticosteroid, glucocorticosteroid with vitamin D3 or montelukast sodium on early immunological and clinical effect of allergen-specific immunotherapy in asthmatic children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Active Comparator |
| |
| II | Active Comparator |
| |
| III | Placebo Comparator |
| |
| A | Active Comparator |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prednisone, lactose | Drug | Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy: 20mg prednisone+ 0.3mg lactose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Regulatory T cell (CD4+CD25+Foxp3 positive) induction measured in peripheral blood mononuclear cells | First visit, second visit (after 3 months) and third visit (after 12 months of immunotherapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokine (IL-10, TGF-beta1, IL-4, IL-5, IL-13) determination in supernatants from peripheral blood mononuclear cells culture. | First visit, second visit (after 3 months) and third visit (after 12 months of immunotherapy) | |
| diary card evaluation with asthma free days estimation, lung function measurement and analysis of reduction of the inhaled corticosteroids dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paweł Majak, MD, PhD | Department of Pediatrics and Allergy, Medical University of Lodz, Poland | Principal Investigator |
| Iwona Stelmach, MD, PhD | 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 Lodz, Poland | 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 |
|---|---|
| D011241 | Prednisone |
| D007785 | Lactose |
| D019819 | Budesonide |
| D002762 | Cholecalciferol |
| C093875 | montelukast |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| prednisone, colecalciferol, lactose | Drug | Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy: 20mg prednisone + 1000j colecalciferol + 0.3mg lactose |
|
|
| lactose | Drug | Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy: 0.3mg lactose |
|
|
| montelukast sodium | Drug | Allergen immunotherapy (build-up phase)premedication with montelukast sodium. Children 6-14 years received 5 mg of montelukast and children > 14 years old received 10mg oral tablet once daily at bedtime |
|
|
| lactose | Drug | Allergen immunotherapy (build-up phase)premedication with 0,3mg lactose once daily at bedtime |
|
|
| Visit first and third visit (after 12 months of immunotherapy) |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |