The Effect of Glucocorticosteroid and Vitamin D3 Administration and Montelukast Treatment on Early Clinical and Immunological Effect of Allergen-Specific Immunotherapy in Asthmatic Children

Condition(s) targeted: Asthma

Intervention: prednisone, lactose (Drug); prednisone, colecalciferol, lactose (Drug); lactose (Drug); montelukast sodium (Drug); lactose (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Medical Universtity of Lodz

Official(s) and/or principal investigator(s):
Paweł Majak, MD, PhD, Principal Investigator, Affiliation: Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Iwona Stelmach, MD, PhD, Prof, Study Chair, Affiliation: Department of Pediatrics and Allergy, Medical University of Lodz, 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. 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

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Secondary outcome:

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

diary card evaluation with asthma free days estimation, lung function measurement and analysis of reduction of the inhaled corticosteroids dose

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.

Minimum age: 6 Years. Maximum age: 18 Years. Gender(s): Both.

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.

Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland, Lodz 93-513, Poland

Starting date: September 2005
Ending date: March 2007
Last updated: July 20, 2007