NCT01291381

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 8, 2011

Completed
Last Updated

February 8, 2011

Status Verified

January 1, 2009

Enrollment Period

1 year

First QC Date

January 25, 2011

Last Update Submit

February 7, 2011

Conditions

Allergic RhinitisEffects of Immunotherapy

Keywords

allergic rhinitisperipheral toleranceregulatory T cellsspecific immunotherapyTr1 cells

Outcome Measures

Primary Outcomes (1)

  • Symptom evaluation

    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).

    Clinical results were based on the patient self-evaluation scores obtained at the beginning and after 3, 6 and 12 months of treatment.

Study Arms (2)

Dermatophagoides pteronyssinus extract

ACTIVE COMPARATOR

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

Drug: Dermatophagoides pteronyssinus

Pharmacotherapy

ACTIVE COMPARATOR

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

Interventions

Dermatophagoides pteronyssinusDRUG

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

Dermatophagoides pteronyssinus extract
PharmacotherapyDRUG

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.

Pharmacotherapy

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Clinical diagnosis of asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the allergy clinic of Beijing TongRen Hospital

Beijing, 100730, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Antigens, DermatophagoidesDrug Therapy

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AntigensBiological FactorsTherapeutics

Study Officials

  • Luo Zhang, M.D

    Beijing Institiute of Otolaryngology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2011

First Posted

February 8, 2011

Study Start

February 1, 2009

Primary Completion

February 1, 2010

Study Completion

October 1, 2010

Last Updated

February 8, 2011

Record last verified: 2009-01

Locations

CN(1)