Clinical trial NCT00504946: Pharmacological Modulations of Allergen-Specific Immunotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: allergen immunotherapy premedication
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2007-07-20
Enrollment: 85
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Regulatory T cell (CD4+CD25+Foxp3 positive) induction measured in peripheral blood mononuclear cells
timeFrame: First visit, second visit (after 3 months) and third visit (after 12 months of immunotherapy)
Secondary outcomes:
measure: Cytokine (IL-10, TGF-beta1, IL-4, IL-5, IL-13) determination in supernatants from peripheral blood mononuclear cells culture.
timeFrame: First visit, second visit (after 3 months) and third visit (after 12 months of immunotherapy)
measure: diary card evaluation with asthma free days estimation, lung function measurement and analysis of reduction of the inhaled corticosteroids dose
timeFrame: Visit first and third visit (after 12 months of immunotherapy)
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland
Study officials:
affiliation: Department of Pediatrics and Allergy, Medical University of Lodz, Poland
name: Paweł Majak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics and Allergy, Medical University of Lodz, Poland
name: Iwona Stelmach, MD, PhD
role: STUDY_CHAIR
References: