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Pharmacological Modulations of Allergen-Specific Immunotherapy

NCT00504946 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2008-04-11

No results posted yet for this study

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

Conditions

Interventions

DRUG

prednisone, lactose

Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy: 20mg prednisone+ 0.3mg lactose

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

DRUG

lactose

Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy: 0.3mg lactose

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

DRUG

lactose

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

Sponsors & Collaborators

  • Medical University of Lodz

    lead OTHER

Principal Investigators

  • Paweł Majak, MD, PhD · Department of Pediatrics and Allergy, Medical University of Lodz, Poland

  • Iwona Stelmach, MD, PhD · Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00504946 on ClinicalTrials.gov