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Pharmacological Modulations of Allergen-Specific Immunotherapy

NCT ID: NCT00504946

Last Updated: 2008-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-03-31

Brief Summary

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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

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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.

Conditions

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Asthma

Keywords

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allergen immunotherapy premedication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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I

Group Type ACTIVE_COMPARATOR

prednisone, lactose

Intervention Type DRUG

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

20mg prednisone+ 0.3mg lactose

II

Group Type ACTIVE_COMPARATOR

prednisone, colecalciferol, lactose

Intervention Type DRUG

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

20mg prednisone + 1000j colecalciferol + 0.3mg lactose

III

Group Type PLACEBO_COMPARATOR

lactose

Intervention Type DRUG

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

0.3mg lactose

A

Group Type ACTIVE_COMPARATOR

montelukast sodium

Intervention Type 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

B

Group Type PLACEBO_COMPARATOR

lactose

Intervention Type DRUG

Allergen immunotherapy (build-up phase)premedication with 0,3mg lactose once daily at bedtime

Interventions

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prednisone, lactose

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

20mg prednisone+ 0.3mg lactose

Intervention Type DRUG

prednisone, colecalciferol, lactose

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

20mg prednisone + 1000j colecalciferol + 0.3mg lactose

Intervention Type DRUG

lactose

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

0.3mg lactose

Intervention Type DRUG

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

Intervention Type DRUG

lactose

Allergen immunotherapy (build-up phase)premedication with 0,3mg lactose once daily at bedtime

Intervention Type DRUG

Other Intervention Names

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Miflonide Pulmicort Miflonide Pulmicort Miflonide Pulmicort Miflonide Pulmicort Miflonide Pulmicort

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Lodz

OTHER

Sponsor Role lead

Responsible Party

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Department of Pediatrics and Allergy

Principal Investigators

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Paweł Majak, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Iwona Stelmach, MD, PhD

Role: STUDY_CHAIR

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

Locations

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

Lodz, , Poland

Site Status

Countries

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Poland

Other Identifiers

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RNN-168-05-KE

Identifier Type: -

Identifier Source: org_study_id