Pharmacological Modulations of Allergen-Specific Immunotherapy

Medical University of Lodz85 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Asthma

Interventions

prednisone, lactoseDRUG

Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy: 20mg prednisone+ 0.3mg lactose

prednisone, colecalciferol, lactoseDRUG

Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy: 20mg prednisone + 1000j colecalciferol + 0.3mg lactose

lactoseDRUG

Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy: 0.3mg lactose

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * allergic asthma with regular symptoms requiring long-term treatment with inhaled corticosteroids * disease duration of at least 2 years * sensitisation only to house dust mites * resting FEV1 of more or equal 70% Exclusion Criteria: * sensitization to allergens other than house dust mites * discontinuation of SIT from any reasons * need of a daily dose below 200 or above 800 mcg of budesonide or equivalent * other chronic disease including vitamin D3 deficiency and/or resistance which could influence the results of the study or the patient's ability to participate in the study as judged by the investigator * medications that resulted in patient exclusion included: inhaled long acting β2-agonist, leukotriene modifiers, β-blockers (eye drops included) or oral corticosteroids within 6 month before the pre-study visit.

Locations (1)

Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland

Lodz, Poland

Outcomes

Primary Outcomes

Regulatory T cell (CD4+CD25+Foxp3 positive) induction measured in peripheral blood mononuclear cells

Time frame: First visit, second visit (after 3 months) and third visit (after 12 months of immunotherapy)

Secondary Outcomes

Cytokine (IL-10, TGF-beta1, IL-4, IL-5, IL-13) determination in supernatants from peripheral blood mononuclear cells culture.

Time frame: 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

Time frame: Visit first and third visit (after 12 months of immunotherapy)

Data from ClinicalTrials.gov

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