Comparing the effectiveness of desloratadine plus montelukast combination therapy and desloratadine monotherapy on quality of life in patients with persistent allergic rhinitis
Determining and comparing the effect of combination therapy of des loratadine and montelukast with single drug treatment of des loratadine on the quality of life of patients with stable allergic rhinitis in the Kashan in 2020.
Design
Clinical trial with control group, with parallel group design, double-blind, randomized, phase 2 on 56 patients. For randomization from www. sealedenvelope.com/simple-randomiser/v1/lists and Balanced (permuted) block randomization method was used
Settings and conduct
Preliminary sampling is performed from the ENT clinic of Matini Hospital in Kashan. This study was prepared as double-blind by an expert who did not participate in the study. In such a way that two types of drug packages named A and B were prepared and delivered for using in the control and intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with allergic rhinitis who are symptomatic for more than 4 weeks and also more than 4 days a week; Existence of persistent allergic rhinitis during the last 2 years; Age of 65-18 years old.
Non inclusion criteria:
Reluctance to cooperate; Severe upper respiratory tract disease during the 6 weeks prior to study; Nasal polyp or nasal septum aberration; Acute or chronic rhinosinusitis; Smoking; Bronchial asthma; Antihistamine use in the last 1 month
Intervention groups
Control group: single drug treatment with des loratadine and placebo. In this group, 5 mg des loratadine tablets are used every night for 6 weeks. The placebo is also used similar to the Montelukast protocol.
Intervention group: Treatment with two drugs, des loratadine and montelukast. In this group, 5 mg tablets of des loratadine are used every night for 6 weeks. In this study, Montelukast is used one 10-mg tablet per night for 6 weeks.
Main outcome variables
Quality of life; Runny nose; stuffy nose; sneezing; itching
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200909048677N1
Registration date:2020-10-05, 1399/07/14
Registration timing:retrospective
Last update:2020-10-05, 1399/07/14
Update count:0
Registration date
2020-10-05, 1399/07/14
Registrant information
Name
Shayan Ramezanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
ramezanpour-sh@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of desloratadine plus montelukast combination therapy and desloratadine monotherapy on quality of life in patients with persistent allergic rhinitis
Public title
Comparing the effectiveness of combination therapy and monotherapy on quality of life in patients with persistent allergic rhinitis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with allergic rhinitis who are symptomatic for more than 4 weeks and also more than 4 days a week
Existence of persistent allergic rhinitis during the last 2 years
Age 18-65 years
Exclusion criteria:
unwillingness to cooperate
Severe upper respiratory tract disease during the 6 weeks prior to the study
Nasal polyps or deviation of the nasal septum
Acute or chronic rhinosinusitis
smoking
Bronchial asthma
Pregnancy or breastfeeding
Taking antihistamines during the last 1 month
Use of systemic or topical corticosteroids
History of allergies to Montelukast or Des Loratadine
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
To randomly assign each sample to intervention and control groups, first create a randomization list using the website www. sealedenvelope.com/simple-randomiser/v1/lists and was prepared by Balanced (permuted) block randomization method. According to the entry turn of each sample to the study and random sequence, the individuals are assigned to one of the two groups A (control group) and B (intervention group).
Blinding (investigator's opinion)
Double blinded
Blinding description
Two types of medication packages, called A and B, were designed by an expert who did not participate in the study. One package contained des loratadine tablets and Montelukast tablets. And the other package included des lortadine tablets and placebo.It should be noted that the placebo was quite similar to Montelukast in shape, color and size.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotb-e-Ravandi boulevard
City
kashan
Province
Isfehan
Postal code
8715973474
Approval date
2020-09-01, 1399/06/11
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1399.083
Health conditions studied
1
Description of health condition studied
allergic rhinitis
ICD-10 code
J30
ICD-10 code description
Vasomotor and allergic rhinitis
Primary outcomes
1
Description
Quality of life score
Timepoint
Once before starting treatment and once 6 weeks after starting treatment.
Method of measurement
mini-RQLQ checklist
Secondary outcomes
1
Description
Runny nose
Timepoint
Once before treatment and once 6 weeks after
Method of measurement
Nasal symptom score checklist. The severity of these symptoms is assessed based on the nasal symptom score. In this questionnaire, the patient scores the 4 main symptoms of allergic rhinitis from 0 (absence of the desired symptom) to 3 (severe).
2
Description
Sneezing
Timepoint
Once before treatment and once 6 weeks after.
Method of measurement
Nasal symptom score checklist. The severity of these symptoms is assessed based on the nasal symptom score. In this questionnaire, the patient scores the 4 main symptoms of allergic rhinitis from 0 (absence of the desired symptom) to 3 (severe).
3
Description
Nasal congestion
Timepoint
Once before treatment and once 6 weeks after.
Method of measurement
Nasal symptom score checklist. The severity of these symptoms is assessed based on the nasal symptom score. In this questionnaire, the patient scores the 4 main symptoms of allergic rhinitis from 0 (absence of the desired symptom) to 3 (severe).
4
Description
Itching
Timepoint
Once before treatment and once 6 weeks after.
Method of measurement
Nasal symptom score checklist. The severity of these symptoms is assessed based on the nasal symptom score. In this questionnaire, the patient scores the 4 main symptoms of allergic rhinitis from 0 (absence of the desired symptom) to 3 (severe)
Intervention groups
1
Description
Intervention group: The recipient group is a combination of desloratadine and Montelukast. In this study, 5 mg des loratadine tablets made by Abidi Pharmaceutical Company, 1 tablet every night for 6 weeks of intervention are used. In addition, 10 mg Montelukast tablets made by Abidi Pharmaceutical Company are used, 1 tablet every night for 6 weeks of intervention. During this period, the use of drugs is controlled by telephone.
Category
Treatment - Drugs
2
Description
Control group: group of des loratadine and placebo. In this study, 5 mg des loratadine tablets made by Abidi Pharmaceutical Company, 1 tablet every night for 6 weeks of intervention are used. In addition placebo which is quite similar to Abidi's Montelukast tablet and is made from the same company is used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Matini Hospital Clinic
Full name of responsible person
Shayan Ramezanpour
Street address
Amirkabir street
City
Kashan
Province
Isfehan
Postal code
87196 74591
Phone
+98 31 5534 2020
Email
info@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Seyyed Alireza Moraveji
Street address
Kashan University of Medical Sciences, Ghotb-e-Ravandi boulevard
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
info@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
personal
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Shayan Ramezanpour
Position
intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Kashan University of Medical Sciences, Ghotb-e-Ravandi boulevard
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5546 4950
Email
dr.sh.ramezanpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir Hossenin Ahsani Arani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Matini hospital, Amir kabir street
City
Kashan
Province
Isfehan
Postal code
87196 74591
Phone
+98 31 5534 2020
Email
amirhosein.ahsani1397@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Shayan Ramezanpour
Position
intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Kashan University of Medical Sciences, Ghotb-e-Ravandi boulevard
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
dr.sh.ramezanpour@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
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