Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland
Lodz, 93-513, Poland
NCT Number: NCT00504946
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
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Notify Me6 year–18 year
All sexes
Interventional
Phase 3
Lodz, 93-513, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy:
20mg prednisone+ 0.3mg lactose
Other names: Miflonide, Pulmicort
Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy:
20mg prednisone + 1000j colecalciferol + 0.3mg lactose
Other names: Miflonide, Pulmicort
Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy:
0.3mg lactose
Other names: Miflonide, Pulmicort
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
Other names: Miflonide, Pulmicort
Time frame: First visit, second visit (after 3 months) and third visit (after 12 months of immunotherapy)
Time frame: First visit, second visit (after 3 months) and third visit (after 12 months of immunotherapy)
Time frame: Visit first and third visit (after 12 months of immunotherapy)
Medical University of Lodz
Other
The Effect of Glucocorticosteroid and Vitamin D3 Administration and Montelukast Treatment on Early Clinical and Immunological Effect of Allergen-Specific Immunotherapy in Asthmatic Children, Double-Blind, Placebo-Controlled Study
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