Determining the effectiveness of intranasal corticosteroids in adults with idiopathic urticaria and positive prick test with airborne allergens
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 69 patients. The rand function of Excel software was used for randomization.
Settings and conduct
This study is conducted in asthma and allergy clinics affiliated to Shiraz University of Medical Sciences. Researchers and patients will not be aware of the type of treatment or placebo. The sealed envelope method will be used.
Participants/Inclusion and exclusion criteria
The participants in this study will include adult patients aged 18 years and older who have been diagnosed with idiopathic urticaria based on clinical criteria and have tested positive for air allergens in the prick test. Participants will be randomly selected from adult allergy clinics. Informed consent will be obtained from the participants. Patients who cannot participate during six months. Patients who have serious side effects due to the use of corticosteroids before the start of the study. Patients who have serious side effects due to the use of corticosteroids during the study period will be excluded from the study.
Intervention groups
The intervention group will be treated with Nasal Budesonide (with a dose of 32 micrograms per spray) twice a day. Participants in this group will be instructed on the correct method of administration and compliance will be monitored throughout the study period.The control group will receive a placebo spray.
The effect of intranasal corticosteroids in adults with chronic idiopathic urticaria and positive prick test with aeroallergens
Public title
The effect of intranasal corticosteroids on chronic idiopathic urticaria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients must be older than eighteen years.
Patients must have a diagnosis of idiopathic urticaria and positive prick test results for airborne antigens.
Patients must choose from adult allergy clinics and declare their informed consent to participate in the study.
Exclusion criteria:
Patients who are under treatment other than antihistamines by a doctor specializing in asthma and allergies.
Patients who cannot participate during six months.
Patients who had serious side effects due to corticosteroids before the start of the study.
Patients who have serious side effects caused by the use of corticosteroids during the study period.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
69
Randomization (investigator's opinion)
Randomized
Randomization description
1. generation of Allocation Sequence : A unique identification number is assigned to each participant upon enrollment. A computer generates a randomization code for each participant using a random number generator, ensuring that each code is independent of the others.
2. Preparation of Allocation Envelopes: Each randomization code is enclosed in a sequentially numbered, opaque envelope, concealing the allocation. The envelopes are identical in appearance and are thoroughly mixed to ensure unpredictability.
3. Participant Allocation: When a participant is ready to be assigned to a study group, an independent researcher not involved in participant recruitment or data collection selects an envelope at random and allocates the participant to the corresponding group as specified by the code within the envelope, ensuring concealment of the allocation until this point. This process is continued for each subsequent participant, guaranteeing impartial assignment to the intervention or control group based solely on chance.
Blinding (investigator's opinion)
Double blinded
Blinding description
Allocation to treatment or placebo is concealed from researchers, participants, and their families to ensure blinding.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand st, Shiraz university of medical sciences
City
Shiraz
Province
Fars
Postal code
7196878971
Approval date
2023-11-06, 1402/08/15
Ethics committee reference number
IR.SUMS.MED.REC.1402.367
Health conditions studied
1
Description of health condition studied
Idiopathic urticaria
ICD-10 code
L50.1
ICD-10 code description
Idiopathic urticaria
Primary outcomes
1
Description
Primary outcome measures include the frequency and severity of urticaria symptoms, which are evaluated using valid scoring systems such as the Urticaria Activity Score and the Urticaria Severity Score.
Timepoint
At the beginning of the study (before the start of the intervention) and six months after the start of corticosteroid use
Method of measurement
Urticaria severity and activity questionnaire
Secondary outcomes
1
Description
Secondary outcome measures will include the impact of urticaria on quality of life and daily activities, which will be evaluated using age-appropriate validation questionnaires.
Timepoint
At the beginning of the study (before the start of the intervention) and six months later
Method of measurement
Questionnaire of the effect of urticaria on the quality of life
Intervention groups
1
Description
Intervention group: The intervention group will be treated with Nasal Budesonide (with a dose of 32 micrograms per spray) twice a day. The specific corticosteroid and dose will be determined based on previous studies and standard clinical practice. Participants in this group will be instructed on the correct method of administration and compliance will be monitored throughout the study period.
Category
Treatment - Drugs
2
Description
Control group: 0.9% sodium chloride spray as a placebo, which looks and smells similar to budesonide nasal spray. Two sprays in each nostril twice a day for up to six months, the patient will be visited on the first day and after six months, the nasal corticosteroid will be at a dose of 32 micrograms per spray. The form of spray and placebo will be the same.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza clinic
Full name of responsible person
Hossein Esmaeilzadeh
Street address
Nemazee square, Emam Reza clinic
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3647 4673
Email
esmailzadeh_ho@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Zand st
City
Shiraz
Province
Fars
Postal code
7196878971
Phone
+98 71 3636 5898
Email
hashempour@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Hassan Mohtadi
Position
Asthma fellowship candidate
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Zand st, Shiraz university of medical sciences
City
Shiraz
Province
Fars
Postal code
7196878971
Phone
+98 71 3636 5895
Email
Hasanmohtadi@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hassan Mohtadi
Position
Asthma fellowship candidate
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Zand st, Shiraz university of medical sciences
City
Shiraz
Province
Fars
Postal code
7196878971
Phone
+98 71 3636 5895
Email
Hasanmohtadi@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hassan Mohtadi
Position
Asthma fellowship candidate
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Zand st, Shiraz university of medical sciences
City
Shiraz
Province
Fars
Postal code
7196878971
Phone
+98 71 3636 5895
Email
Hasanmohtadi@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
It can be provided by reasonable request from the corresponding author.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Only researchers working in academic institutions
Under which criteria data/document could be used
With a reasonable request from the responsible author, any analysis can be done.
From where data/document is obtainable
It can be provided with a reasonable request from the responsible author. Identification and verification information of the center where they work is required.
What processes are involved for a request to access data/document
It can be provided by reasonable request thorough E-Mail from the corresponding author.