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Rush Immunotherapy effects on the gene expression of IL- 4, FoxP3, TGF-β, IL-17, IL-10 and IFN-γ in the perennial allergic rhinitis patients

Protocol summary

Summary
The aim of this study was detection of the effects of Rush Immunotherapy on the gene expression of IL- 4, FoxP3, TGF-β, IL-17, IL-10 and IFN-γ in the perennial allergic rhinitis patients. The study involved 16 patients with perennial allergic rhinitis ranged in age from 15 to 51 years referred to Ghaem Hospital, allergy ward, Mashhad University of Medical Sciences, Mashhad, Iran. Sixteen patients received rush immunotherapy. Quality of life and clinical symptoms of all patients before and after 3 months immunotherapy were completed in questionnaires namely Mini RQLQ and SNOT22, respectively. Blood samples were collected before and after 3 months of immunotherapy. RNA extraction and cDNA synthetize were performed to evaluate the gene expression of FoxP3, TGF-β, IL-17, IL-10, IL-4 and IFN-γ by Real time RT-PCR. Inclusion criteria: the patients with perennial allergic rhinitis between the ages of 15-51 years who had a positive skin test with aero allergens were enrolled to the study. Exclusion criteria: the patients who had history of autoimmune disease, Consumption of immunosuppressive drugs for reasons other than allergic diseases, pregnant women, immunocompromised patients, patients who had uncontrolled allergic asthma and patients who suffered from malnutrition were excluded. Intervention: Injection of concentrated extracts of allergens (salt grass, combined weeds) for immunotherapy was performed by allergist. The main consequence of the study was the evaluation of the gene expression related to FoxP3, TGF-β, IL-17, IL-10, IL-4 and IFN-γ following the rush immunotherapy in patients with allergic rhinitis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017050723235N10
Registration date: 2017-11-04, 1396/08/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-04, 1396/08/13
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
Mashhad University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Rush Immunotherapy effects on the gene expression of IL- 4, FoxP3, TGF-β, IL-17, IL-10 and IFN-γ in the perennial allergic rhinitis patients
Public title
The impact of rapid desensitization in gene expression mediated by the immune system
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The risk of perennial allergic rhinitis; Positive skin test to allergens in the air; Clinical signs associated with skin test Exclusion criteria: History of autoimmune disease; Patients with systemic corticosteroids or immunosuppressive drugs for reasons other than allergic disease on the immune system use to be effective; Pregnancy; Immunocompromised patients, patients who have uncontrolled allergic asthma; Patients with malnutrition; Patients who received beta-blocker drugs; Patients with a history of anaphylaxis; patients With coexisting cardiovascular disease; During treatment, patients who are experiencing systemic reactions; Patients with mental disorders
Age
From 15 years old to 51 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 16
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 commitie of Mashahd University of Medical Sciences
Street address
Ghoreishi building Ethics Committee of Mashahd University of Medical Science
City
Mashhad
Postal code
Approval date
2016-11-12, 1395/08/22
Ethics committee reference number
IR.MUMS.REC.1395.398

Health conditions studied

1

Description of health condition studied
Perennial allergic rhinitis
ICD-10 code
J30.3
ICD-10 code description
Other allergic rhinitis

Primary outcomes

1

Description
Changes in the expression of IL- 4, FoxP3, TGF-β, IL-17, IL-10 and IFN-γ genes in peripheral blood of allergic rhinitis patients
Timepoint
Befor & 3 months after the trial
Method of measurement
Real Time-PCR Technique

2

Description
Quality of life
Timepoint
Befor and 3 months after Rush immunotherapy
Method of measurement
Questionnaires SNOT22 and Mini RQLQ

Secondary outcomes

1

Description
Systemic reactions to immunotherapy
Timepoint
At every turn immunotherapy
Method of measurement
Clinical

Intervention groups

1

Description
Subcutaneous immunotherapy with the Aero allergens
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Allergy Clinic Ghaem Hospital
Full name of responsible person
Amirabass Salmani
Street address
Ghaem Hospital, Ahmad Abad Street, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Ghoreishi,Daneshgah Ave, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
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
Mashahd University of Medical Sciences
Full name of responsible person
Amirabass Salmani
Position
Msc
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmad Abad Ave
City
Mashhad
Postal code
Phone
+98 51 3801 2770
Fax
Email
salmaniaa941@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
Farahzad Jabbari Azad
Position
Associate Professor
Other areas of specialty/work
Street address
Allergy Research Center, Ghaem Hospital , Ahmadabad Ave, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3801 2770
Fax
Email
jabbarif@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Amirabass Salmani
Position
MSC
Other areas of specialty/work
Street address
City
Mashhad
Postal code
Phone
00
Fax
Email
salmaniaa941@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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