Pharmacological Modulations of Allergen-Specific Immunotherapy

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00504946
• Other study ID #: RNN-168-05-KE
• Status: Completed
• Phase: Phase 3
• First received: July 19, 2007
• Last updated: April 8, 2008
• Start date: September 2005
• Est. completion date: March 2007

Study information

• Verified date: April 2008
• Source: Medical Universtity of Lodz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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 ß2-agonist, leukotriene modifiers, ß-blockers (eye drops included) or oral corticosteroids within 6 month before the pre-study visit.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• prednisone, lactose
Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy: 20mg prednisone+ 0.3mg lactose
• prednisone, colecalciferol, lactose
Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy: 20mg prednisone + 1000j colecalciferol + 0.3mg lactose
• lactose
Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy: 0.3mg lactose
• montelukast sodium
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
• lactose
Allergen immunotherapy (build-up phase)premedication with 0,3mg lactose once daily at bedtime

Locations

Country	Name	City	State
Poland	Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland	Lodz

Sponsors (1)

Lead Sponsor	Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regulatory T cell (CD4+CD25+Foxp3 positive) induction measured in peripheral blood mononuclear cells		First visit, second visit (after 3 months) and third visit (after 12 months of immunotherapy)	Yes
Secondary	Cytokine (IL-10, TGF-beta1, IL-4, IL-5, IL-13) determination in supernatants from peripheral blood mononuclear cells culture.		First visit, second visit (after 3 months) and third visit (after 12 months of immunotherapy)	Yes
Secondary	diary card evaluation with asthma free days estimation, lung function measurement and analysis of reduction of the inhaled corticosteroids dose		Visit first and third visit (after 12 months of immunotherapy)	Yes