Evaluation of the effect and side effects of desloratadine in comparison with fexofenadine on allergic rhinitis in patients referred to Masih Daneshvari Hospital
Design
This study is a double-blind clinical trial and randomized groups with simple randomization and phase 2 method on 65 patients with allergic rhinitis. In the first group, patients are treated with desloratadine, and in the second group, they are treated with fexofenadine.
Settings and conduct
Patients with allergic rhinitis referred to Masih Daneshvari Hospital in Tehran are randomly divided into two groups. In group A, patients will receive desloratadine at a dose of 5 mg daily for 4 weeks, and in group B, they will receive 120 mg daily fexofenadine for 4 weeks. Both groups will not receive medication for two weeks. Group A is then given fexofenadine and group B is given desloratadine for four weeks. The study is two-blind, and medications are given to the patient in labeled packages, and patients are kept blind to group assignments. Also, the drug distributor colleague is not aware of this labeling.
Participants/Inclusion and exclusion criteria
Age over 12 years, history of allergic rhinitis or diagnosis at the first visit, written consent
Intervention groups
The first group was treated with 5 mg of desloratadine daily for 4 weeks and the second group was treated with 120 mg of fexofenadine daily for 4 weeks. After stopping the drug for two weeks, the first group received fexofenadine for 4 weeks and the second group received desloratadine for 4 weeks.
Main outcome variables
Clinical symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160516027929N11
Registration date:2021-09-25, 1400/07/03
Registration timing:registered_while_recruiting
Last update:2021-09-25, 1400/07/03
Update count:0
Registration date
2021-09-25, 1400/07/03
Registrant information
Name
Atefeh Fakharian
Name of organization / entity
National research institute of tuberculosis and lung diseases
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2541
Email address
afakharian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-12-06, 1400/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy and side effects of desloratadine with fexofenadine on allergic rhinitis in patients referred to Masih Daneshvari Hospital
Public title
Comparison of the efficacy and side effects of desloratadine with fexofenadine on allergic rhinitis in patients referred to Masih Daneshvari Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 12 years
History of allergic rhinitis or diagnosis at first visit
Written consent to participate in the study
Exclusion criteria:
Sensitivity, allergy or adverse reaction to desloratadine and fexofenadine
Patients who have previously been treated with two or more drugs
pregnancy and breastfeeding
Age
From 12 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple randomization, randomization unit: individual, randomization tool: table of random numbers, To construct a random sequence with the help of a random number table and by the statistical consultant, patients accidentally had one of the even and odd codes. Patients who were assigned even numbers were in the first group and patients with odd codes were in the second group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs are placed in bags that are similar in appearance and are labeled as groups A and B. The patient is unaware of this labeling (aware of receiving medication but kept blind to group assignments). Also, the project partner who distributes the medicine is not aware of this labeling. To avoid any possible complications, the lead researcher is aware of the assignment of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Before starting treatment and 10 weeks after starting treatment
Method of measurement
Rhinitis Quality of Life Questionnaire
2
Description
The severity of eye symptoms
Timepoint
Rhinitis Quality of Life Questionnaire
Method of measurement
Rhinitis Quality of Life Questionnaire
3
Description
Severe itching in the nose
Timepoint
Rhinitis Quality of Life Questionnaire
Method of measurement
Rhinitis Quality of Life Questionnaire
4
Description
sleep disorders
Timepoint
Rhinitis Quality of Life Questionnaire
Method of measurement
Rhinitis Quality of Life Questionnaire
Secondary outcomes
1
Description
Evaluation of the clinical symptoms of allergic rhinitis
Timepoint
Before starting treatment and 10 weeks after starting treatment
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: In the first group, patients receive 5 mg of desloratadine daily for 4 weeks.After 2 weeks of no drug treatment, they are treated with fexofenadine 120 mg daily for 4 weeks.
Category
Treatment - Drugs
2
Description
Intervention group: In the second group, patients received 120 mg of fexofenadine daily for 4 weeks. After two weeks of no drug treatment, they are treated with desloratadine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Atefeh Fakharian
Street address
Darabadو Shahid Bahonar St. (Niavaran)
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
fakharian_2005@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Abbas Arabi St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
198396411
Phone
+98 21 2243 9781
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Fakharian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
(Niavaran), Darabad, Shahid Bahonar St.
City
: Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
fakharian_2005@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Fakharian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
(Niavaran), Darabad, Shahid Bahonar St.
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
fakharian_2005@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Fakharian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
(Niavaran), Darabadو Shahid Bahonar St.
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
fakharian_2005@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is currently no program
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
Undecided - It is not yet known if there will be 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