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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

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ClinicalTrials.gov Identifier: NCT01291381
Recruitment Status : Completed
First Posted : February 8, 2011
Last Update Posted : February 8, 2011
Sponsor:
Information provided by:
Beijing Tongren Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Allergic Rhinitis Effects of Immunotherapy Drug: Dermatophagoides pteronyssinus Drug: Pharmacotherapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Regulatory T Cells in the Response to SIT in Allergic Rhinitis.
Study Start Date : February 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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. ]
    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).



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Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Professor Luo Zhang, Capital Medical University
ClinicalTrials.gov Identifier: NCT01291381     History of Changes
Other Study ID Numbers: 2011-BIO-01
81025007 ( Other Grant/Funding Number: the National Science Fund )
First Posted: February 8, 2011    Key Record Dates
Last Update Posted: February 8, 2011
Last Verified: January 2009

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

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
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
Physiological Effects of Drugs