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

This study has been completed.
Sponsor:
Information provided by:
Beijing Tongren Hospital
ClinicalTrials.gov Identifier:
NCT01291381
First received: January 25, 2011
Last updated: February 7, 2011
Last verified: January 2009
  Purpose

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.


Condition Intervention
Allergic Rhinitis
Effects of Immunotherapy
Drug: Dermatophagoides pteronyssinus
Drug: Pharmacotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Regulatory T Cells in the Response to SIT in Allergic Rhinitis.

Resource links provided by NLM:


Further study details as provided by Beijing Tongren Hospital:

Primary Outcome Measures:
  • Symptom evaluation [ Time Frame: Clinical results were based on the patient self-evaluation scores obtained at the beginning and after 3, 6 and 12 months of treatment. ] [ Designated as safety issue: No ]
    Symptoms of AR children were assessed by the Total 5 Symptom Score (T5SS), which includes rhinorrhea, sneezing, nasal congestion, and nasal and ocular pruritus. Each symptom was scored on a scale of 0-3 (0 = none, 3 = severe).


Enrollment: 50
Study Start Date: February 2009
Study Completion Date: October 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dermatophagoides pteronyssinus extract
Children undergoing subcutaneous immunotherapy were given Dermatophagoides pteronyssinus extract (Alutard SQ, ALK-Abello, Hørsholm, Denmark) according to a cluster protocol
Drug: Dermatophagoides pteronyssinus
Children undergoing subcutaneous immunotherapy were given Dermatophagoides pteronyssinus extract (Alutard SQ, ALK-Abello, Hørsholm, Denmark) according to a cluster protocol
Active Comparator: Pharmacotherapy
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.
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   9 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Allergic rhinitis
  • Han nationality
  • Had a history of HDM-induced moderate or severe rhino-conjunctivitis of at least three years duration
  • Had a positive skin prick test (SPT) result for Der p (ALK-Abello', Hørsholm, Denmark) with a wheal diameter of at least 6 mm
  • Were positive for specific immunoglobulin E (IgE) to Der p (Pharmacia CAP System, Pharmacia Diagnostics, Uppsala, Sweden), with a RAST value of at least 0.7 kU/L

Exclusion Criteria:

  • Clinical diagnosis of asthma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291381

Locations
China
the allergy clinic of Beijing TongRen Hospital
Beijing, China, 100730
Sponsors and Collaborators
Beijing Tongren Hospital
Investigators
Principal Investigator: Luo Zhang, M.D Beijing Institiute of Otolaryngology
  More Information

No publications provided

Responsible Party: Professor Luo Zhang, Capital Medical University
ClinicalTrials.gov Identifier: NCT01291381     History of Changes
Other Study ID Numbers: 2011-BIO-01, 81025007
Study First Received: January 25, 2011
Last Updated: February 7, 2011
Health Authority: China: Beijing Municipal Science and Technology Commission

Keywords provided by Beijing Tongren Hospital:
allergic rhinitis
peripheral tolerance
regulatory T cells
specific immunotherapy
Tr1 cells

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Histamine Antagonists
Histamine H1 Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014