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Regulatory Lymphocytes in Patients Treated With Specific Immunotherapy

NCT01475188 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2011-11-21

No results posted yet for this study

Summary

The purpose of this study is to determine whether specific subcutaneous immunotherapy affects fractions of regulatory T lymphocytes and histamine H2 receptor expression and ZAP70 in regulatory T lymphocytes.

Conditions

  • Immunotherapy
  • Seasonal Allergic Rhinitis

Interventions

DRUG

Allergovit

commercially available grass pollen allergoid (100%), concentration A (1000 TU/ml, therapeutic units/ml)concentration B (10000 TU/ml).Patients were given subcutaneous injections with initial dose of 0.1 ml (concentration A) was increased once a 7 (+7) days until the highest tolerated dose (0.6, concentration B) was reached and SIT was continued with injections once every 4 - 6 weeks up to two years.

OTHER

placebo

placebo administered with the same scheme and doses as specific subcutaneous immunotherapy

Sponsors & Collaborators

  • Ministry of Science and Higher Education, Poland

    lead OTHER_GOV

Principal Investigators

  • Paweł Górski, Prof, MD, PhD · Department of Pneumonology and Allergy, Medical University of Lodz, Poland

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2010-10-31
Completion
2010-12-31

Countries

  • Poland

Study Locations

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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 NCT01475188 on ClinicalTrials.gov