Pharmacological Modulations of Allergen-Specific Immunotherapy

Medical University of Lodz

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: prednisone, colecalciferol, lactose; Drug: lactose; Drug: montelukast sodium; Drug: prednisone, lactose

Study type: Interventional

Funder types: Other

Identifiers

NCT00504946

RNN-168-05-KE

Details and patient eligibility

About

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

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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85 participants in 5 patient groups, including a placebo group

I

Active Comparator group

Treatment:

Drug: prednisone, lactose

II

Active Comparator group

Treatment:

Drug: prednisone, colecalciferol, lactose

III

Placebo Comparator group

Treatment:

Drug: lactose

Drug: lactose

A

Active Comparator group

Treatment:

Drug: montelukast sodium

B

Placebo Comparator group

Treatment:

Drug: lactose

Drug: lactose