Comparison of the therapeutic response of immunotherapy with aeroallergens and drug treatment in patients with allergic rhinitis referred to Imam Ali Clinic
Design
Double-blind randomized clinical trial with parallel and 2 intervention groups, with a sample size of 120
Settings and conduct
This study was performed on 120 patients with allergic rhinitis who referred to Imam Ali clinic in Shahrekord. Patients will be randomly assigned to one of the two intervention groups by selecting a code. Patients and researcher are unaware of the type of treatment that each group receives. A group received common drug treatment included inhaled glucocorticoids and antihistamines once a day for one month, and the other group after doing the prick test and if it was positive underwent immunotherapy with aeroallergens prepared by american Hollister animal husbandry company. Then, the response to treatment was measured based on the patient's satisfaction with symptom improvement.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 10 and over 10 years; Age less than 50 years; Lack of advanced and severe asthma; Negative pregnancy test for women; Lack of autoimmune disease; Lack of immunodeficiency disease; Lack of malignancy;
Exclusion criteria: Patient lack of cooperation; Continuous use of immunosuppressive drugs; Continuous use of antihistamines; Taking beta-blocker medications; History of allergy to each of the treatment groups
Intervention groups
Intervention groups include the group receiving the usual drug treatment, including inhaled glucocorticoids (fluticasone) and antihistamines, and the group under immunotherapy with allergens.
Main outcome variables
Clinical response, Patients' satisfaction with symptom therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N15
Registration date:2019-07-11, 1398/04/20
Registration timing:prospective
Last update:2019-07-11, 1398/04/20
Update count:0
Registration date
2019-07-11, 1398/04/20
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of immunotherapy with aeroallergens and drug treatment in patients with allergic rhinitis
Public title
Comparison of immunotherapy with aeroallergens and drug treatment in patients with allergic rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 10 and over 10 years
Age less than 50 years
Lack of advanced and severe asthma
Negative pregnancy test for women
Lack of autoimmune disease
Lack of immunodeficiency disease
Lack of malignancy
Exclusion criteria:
Patient lack of cooperation
Continuous use of immunosuppressive drugs
Continuous use of antihistamines
Taking beta-blocker medications
History of allergy to each of the treatment groups
Age
From 10 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize the study, simple randomization with individual unit was used, so that patients randomly selected one of the cards containing the code A or B so they entered one of the two treatment groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713492
Approval date
2018-07-22, 1397/04/31
Ethics committee reference number
IR.SKUMS.REC.1397.117
Health conditions studied
1
Description of health condition studied
Allergic rhinitis
ICD-10 code
J30.9
ICD-10 code description
Allergic rhinitis, unspecified
Primary outcomes
1
Description
Sneeze
Timepoint
Before intervention, 2 years after intervention
Method of measurement
Checklist containing clinical symptoms
2
Description
Cough
Timepoint
Before intervention, 2 years after intervention
Method of measurement
Checklist containing clinical symptoms
3
Description
Rhinorrhea
Timepoint
Before intervention, 2 years after intervention
Method of measurement
Checklist containing clinical symptoms
4
Description
Itchy eyes
Timepoint
Before intervention, 2 years after intervention
Method of measurement
Checklist containing clinical symptoms
5
Description
Itchy throat
Timepoint
Before intervention, 2 years after intervention
Method of measurement
Checklist containing clinical symptoms
6
Description
Post nasal discharge
Timepoint
Before intervention, 2 years after intervention
Method of measurement
Checklist containing clinical symptoms
7
Description
Nasal congestion
Timepoint
Before intervention, 2 years after intervention
Method of measurement
Checklist containing clinical symptoms
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients received the usual drug treatment, including inhaled glucocorticoids (Fluticasone) and antihistamines once a day for one month.
Category
Treatment - Drugs
2
Description
Intervention group: Patients who had a positive prick test underwent immunotherapy with allergen extract with three vials diluted 1: 10,000 pg per week for 10 sessions, 1: 1000 pg every other week for 10 sessions and then dilution of 1: 100 pg every month for 2 years.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Clinic
Full name of responsible person
Mohammad Ali Zamani
Street address
Shariati Blvd., Imam Ali Clinic
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816788640
Phone
+98 38 3224 2696
Email
Zamani.m@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. seyed Kamal Solati(Associate Professor of Psychology)
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
kamal_solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mohammad Ali Zamani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
zamani.m@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mohammad Ali Zamani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3227 4004
Email
zamani.m@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mohammad Ali Zamani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
zamani.m@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information on the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Kashani Hospital in Shahrekord, zamani.m@skums.ac.ir
What processes are involved for a request to access data/document
After the investigation of resercher request and presentation of required documents will be accessible.