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Completed

NCT Number: NCT00504946

Pharmacological Modulations of Allergen-Specific Immunotherapy

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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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Lodz, 93-513, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

prednisone, lactose

Drug

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

20mg prednisone+ 0.3mg lactose

Other names: Miflonide, Pulmicort

prednisone, colecalciferol, lactose

Drug

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

lactose

Drug

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

0.3mg lactose

Other names: Miflonide, Pulmicort

montelukast sodium

Drug

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

Primary outcomes

  1. 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

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jul 20, 2007
Registry last updated
Apr 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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