Objective: Subcutaneous immunotherapy with specific allergen in allergic rhinitis is the only effective approved procedure. Aim of this study is evaluation of inhibitory responses by subcutaneous immunotherapy in allergic rhinitis treatment.
Design: Inhibitory responses of regulatory cells are considered by evaluation of cytokines lymphocytes changes before and after the treatment by subcutaneous immunotherapy.
Setting and conduct: Lymphocyte changes for 23 patients with perennial allergic rhinitis are done before and after treatment of subcutaneous immunotherapy by real time PCR.
Participants: 23 patients of perennial allergic rhinitis ranged between 10 to 45 years old, residence in Mashhad, have positive skin test to the local common aeroallergens and are willing to cooperate in the project, are entered to study. Also patients with seasonal allergic rhinitis, history of autoimmune disease and allergic asthma are excluded the study.
Intervention: Subcutaneous injection of condensed allergens based on the approved protocol of American Academy of Asthma, Allergy and Immunology are performed for patients.
Main outcome: Lymphocytes changes of cytokines including IFN gamma, IL 10, IL 4, FOXP3, GITR and TGF beta before and after the treatment of subcutaneous immunotherapy are evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071623235N1
Registration date:2015-12-02, 1394/09/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-02, 1394/09/11
Registrant information
Name
Farahzad Jabbari Azad
Name of organization / entity
Allergy Research Center, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2770
Email address
jabbarif@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2010-05-23, 1389/03/02
Expected recruitment end date
2011-06-23, 1390/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Regulatory T cells in allergic rhinitis patients: before and after one year of immunotherapy
Public title
Immunological changes of Immmunotherapy in allergic rhinitis
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: All patients with persistent allergic rhinitis aged 45-10 years; Residence in Mashhad that have positive skin test to the local common aeroallergens and are willing to cooperate in the project.
Exclusion criteria:
Patients with seasonal allergic rhinitis, patients who have a history of autoimmune disease;Patients who consumed steroids or immunosuppressive drugs and effective on immune system; Pregnant women; Patients with immune deficiencies diseases, Patients with allergic asthma; Patients with malnutrition
Age
From 10 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Postal code
Approval date
2014-01-19, 1392/10/29
Ethics committee reference number
89019
Health conditions studied
1
Description of health condition studied
Allergic Rhinitis
ICD-10 code
J30.3
ICD-10 code description
Perennial allergic rhinitis
Primary outcomes
1
Description
Cytokines Variations
Timepoint
Comparison baseline and terminal sample, after one year of treatment course
Method of measurement
Measuring selective cytokines by Real time PCR
Secondary outcomes
1
Description
Systemic reactions to immunotherapy
Timepoint
Each immunotherapy session
Method of measurement
Clinical evaluation
Intervention groups
1
Description
Subcutaneous injection of condensed allergens based on the approved protocol of American Academy of Asthma, Allergy and Immunology
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Allergy Clinic of Ghaem Hospital
Full name of responsible person
Dr Mohammad Ali Zamani
Street address
Ghaem Hospital, Mashhad University of Medical Sciences
City
Mashhad
2
Recruitment center
Name of recruitment center
Allergy Clinic of Dr Reza Farid Hosseini
Full name of responsible person
Dr Reza Faridhosseini
Street address
Chamran 7, Jahanbani Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences, Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Zamani
Position
Fellowship of pediatric Allergy
Other areas of specialty/work
Street address
Allergy research Center, Ghaem Hospital, Ahmad Abad Avenue
City
Mashhad
Postal code
Phone
+98 51 3801 2770
Fax
Email
arc@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Allergy Research Center, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
Full name of responsible person
Dr Reza Farid Hosseini
Position
Professor of Immunology, Associate Professor of Clinical Immunology and Allergy
Other areas of specialty/work
Street address
Immunology and Allergy Department, Ghaem Hospital, Ahmad Abad Avenue, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3801 2738
Fax
Email
rfaridh@gmail.com, Jabbarif@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Immunology Research Center
Full name of responsible person
Hadis Yousefzadeh
Position
PhD by Research student of Immunology
Other areas of specialty/work
Street address
BuAli Research Institute, BuAli Square
City
Mashhad
Postal code
Phone
Fax
Email
yousefzadehh901@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)