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Distinct Response of CD4+CD25+Foxp3+ and IL-10-secreting Type I T Regulatory Cells to Cluster Specific Immunotherapy in Allergic Rhinitis Children

NCT01291381 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-02-08

No results posted yet for this study

Summary

While allergen specific immunotherapy (SIT) is highly effective for allergic diseases in children, the underlying immunological mechanisms are unclear. Regulatory T (Treg) cells may be crucial in induction of tolerance.

Our aim was to investigate the role of CD4+CD25+Foxp3+ T cells and IL-10-secreting type I T regulatory (Tr1) cells in the response to one year of cluster SIT to Dermatophagoides pteronyssinus for allergic rhinitis in children.

CD4+CD25+Foxp3+regulatory T cells and IL-10-secreting type I T regulatory (Tr1) cells were analyzed in children allergic to Dermatophagoides pteronyssinus during one year cluster specific immunotherapy (SIT) in a prospective and randomized study. Peripheral blood mononuclear cells (PBMCs) were collected from 25 children receiving SIT and 21 receiving pharmacotherapy. The frequencies of CD4+CD25+Foxp3+ T cells and allergen-specific IL-10+IL-4-, IFN-γ+IL-4-, IL-4+IFN-γ-CD4+ T cells were measured by flow cytometry. Production of IL-4, IFN-r, and IL-10 in supernatants from allergen-stimulated PBMC culture was measured by ELISA. Finally, the suppressive effect of CD4+CD25highTreg cells from both groups was estimated.

Conditions

  • Allergic Rhinitis
  • Effects of Immunotherapy

Interventions

DRUG

Dermatophagoides pteronyssinus

Children undergoing subcutaneous immunotherapy were given Dermatophagoides pteronyssinus extract (Alutard SQ, ALK-Abello, Hørsholm, Denmark) according to a cluster protocol

DRUG

Pharmacotherapy

For patients randomized to non-SIT group, persistent rhinitis was managed with pharmacotherapy including intranasal steroids and oral antihistamines. Intranasal steroids were kept at the same dose during the study and antihistamines were used as required.

Sponsors & Collaborators

  • Beijing Tongren Hospital

    lead OTHER

Principal Investigators

  • Luo Zhang, M.D · Beijing Institiute of Otolaryngology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-02-28
Completion
2010-10-31

Countries

  • China

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 NCT01291381 on ClinicalTrials.gov