A multi-centers Non-inferiority clinical trials for evaluating the efficacy of inhalant and food allergic extracts made from domestic sources by skin prick testing in comparison of their matched commercial extracts on a group of patients with history of allergic diseases visiting allergy clinics
Comparison of the efficacy of domestic extracts and their matched commercial extracts in skin prick testing
Comparison of the sensitivity of domestic extracts and their matched commercial extracts in skin prick testing
Comparison of the specificity of domestic extracts and their matched commercial extracts in skin prick testing
Comparison of the side effects of domestic extracts and their matched commercial extracts in skin prick testing
Design
A non-inferiority clinical trial with parallel group , no randomized, not blinded, , phase 2 , on 102 patients with history of allergy
Settings and conduct
This trial will conducted in several allergy clinics in different cities including Birjand, Shiraz and Mashhad. Allergic patients who are candidate for skin prick testing will be informed about the aims of the study and after their approval for participating in the study and receiving consent form, skin prick test will be performed with commercial allergenic extracts and the results will be recorded. After that, skin prick test will be performed with 5 to 10 of matched domestic extracts on the patient's other hand and the results will be recorded as well. The result of skin reactivity to commercial and domestic extracts as well as immediate and late (during the first 24 hours) side effects for both extracts will be evaluated and compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: History of respiratory or food allergy
Exclusion criteria: History of anaphylaxis or uncontrolled asthma
Intervention groups
Patients with history of respiratory or food allergy who should perform skin prick test with commercial extracts will tested with matched domestic extracts as well
Main outcome variables
positive skin reaction; Negative skin reaction, side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181216042006N1
Registration date:2020-12-07, 1399/09/17
Registration timing:prospective
Last update:2020-12-07, 1399/09/17
Update count:0
Registration date
2020-12-07, 1399/09/17
Registrant information
Name
Mohammad Fereidouni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3243 3004
Email address
dr.m.fereidouni@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A multi-centers Non-inferiority clinical trials for evaluating the efficacy of inhalant and food allergic extracts made from domestic sources by skin prick testing in comparison of their matched commercial extracts on a group of patients with history of allergic diseases visiting allergy clinics
Public title
Comparison of the efficacy of domestic allergenic extracts with matched commercial imported extracts
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
patients with history of allergy to inhalant or food allergens who visit allergy clinics and are candidate of performing skin prick test by specialist
Exclusion criteria:
Having serious health problems such as cancer, immunodeficiency, autoimmunity, cardiac disease and severe infection
Pregnancy or breastfeeding
History of anaphylaxis or uncontrolled asthma
Current dermatographism or urticaria
History of allergy immunotherapy during the last 5 years
Using medicine which interfere with skin prick test such as antihistamines, oral corticosteroids, narcotics or sedatives during the last week
Age
From 2 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
107
More than 1 sample in each individual
Number of samples in each individual:
10
Up to five food extracts and up to 10 inhalant extracts can be tested in each case
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Birjand University of Medical Sciences
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
9717686735
Approval date
2020-03-03, 1398/12/13
Ethics committee reference number
IR.BUMS.REC.1398.376
Health conditions studied
1
Description of health condition studied
Allergic rhinitis
ICD-10 code
J30.1
ICD-10 code description
Allergic rhinitis due to pollen
2
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
3
Description of health condition studied
Atopic dermatitis
ICD-10 code
L20
ICD-10 code description
Atopic dermatitis
4
Description of health condition studied
Food allergy
ICD-10 code
Z91.01
ICD-10 code description
Food allergy status
Primary outcomes
1
Description
positive skin reactivity to domestic extracts in comparison to commercial extracts
Timepoint
15 minutes after doing skin prick test
Method of measurement
Area of wheal created by extracts in square milometers
Secondary outcomes
1
Description
Side effects of skin prick testing with commercial or domestic extracts including large local reactions or systemic reactions
Timepoint
during the first 24 hours after doing skin prick test
Method of measurement
A design questionnaire
Intervention groups
1
Description
Intervention group: allergic patients who are referred to allergy clinic and are candidate of skin prick test with commercial extracts from Stallergen or Greer Companies. Based on the patient's history and symptoms, skin prick test usually performs with a battery of 20 -30 allergenic extracts from plants' pollen, foods or animals. one drop of each allergenic extracts placed on volar surface of patient's hand and after a small scratch with sterile lancet, the area of wheal and flare recorded after 15 minutes.
Category
Diagnosis
2
Description
Intervention group: allergic patients who are referred to allergy clinic and are candidate of skin prick test and the prick test performed with commercial extracts from Stallergen or Greer Companies, will be tested with domestic extracts on their other hand and after finishing testing with commercial extracts. Based on the patient's history and symptoms, skin prick test usually performs with a battery of 20 -30 allergenic extracts from plants' pollen, foods or animals. one drop of each allergenic extracts placed on volar surface of patient's hand and after a small scratch with sterile lancet, the area of wheal and flare recorded after 15 minutes. After doing skin prick test with commercial extracts and receiving consent form from patients, skin prick test with some of the match domestic extracts will performed on the patient's other hand and the result will be recorded. Domestic extracts were prepared from pollen of some common allergenic plants in Iran as well as food allergens. In case of pollen's extracts, during pollination season, the pollens were collected and with using specific sieves and sedimentation methods, pure pollen achieved and the purity was approved by microscopic evaluation. after that, 1 gram of pure pollen was mixed with 9 milliliters of aqueous buffer for 24 hours and after centrifugation and filtering, total amount of protein in the extracts was measured. In the next step and to evaluate the pattern of allergenic bands in the extracts, SDS-PAGE was performed and finally the sterilization process was done and microbial cultured approved the sterility of the extracts. For stability testing, the extracts were stored either at 37 centigrade degree for 2 months or at 25 centigrade degree for 6 months and after that the quantity and quality of extracts were measured. In case of good stability and sterility the extracts were mixed with equal amount of sterile glycerol and after packaging and labeling will be used for skin prick testing. The result of skin sensitivity and side effects with both commercial and domestic extracts were compared by using proper statistical tests.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized Clinic of Emam Reza Hospital, Birjand University of Medical Sciences
Full name of responsible person
Mohammad Fereidouni
Street address
Taleghani 9 street
City
Birjand
Province
South Khorasan
Postal code
9717686735
Phone
+98 56 3222 2600
Email
htgbirjand@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tooba Kazemi
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
9717686735
Phone
+98 56 3238 1500
Email
htgbirjand@gmail.com
Grant name
Grant code / Reference number
5147
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Fereidouni
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Allergy
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
9717686735
Phone
009856323381500
Email
dr.m.fereidouni@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Fereidouni
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Ghaffari street, Birjand Univeristy of Medical Sciences, Birjand, Iran
City
Birjand
Province
South Khorasan
Postal code
9717686735
Phone
+98 56 3243 3004
Fax
Email
dr.m.fereidouni@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Fereidouni
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medicine
Street address
Ghaffari street, Birjand Univeristy of Medical Sciences, Birjand, Iran
City
Birjand
Province
South Khorasan
Postal code
9717686735
Phone
+98 56 3243 3004
Fax
Email
dr.m.fereidouni@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Some data will be released
When the data will become available and for how long
Starting 6 months after publishing the results
To whom data/document is available
Medical universities affiliates
Under which criteria data/document could be used
Will evaluate on demand
From where data/document is obtainable
Responsible person
What processes are involved for a request to access data/document
Written request with including the purpose of request