1)Evaluation the quality of life in moderate to severe allergic rhinitis via SNOT22 questionnaire; 2) Evaluation the quality of life in patients with moderate to severe allergic rhinitis in three groups after treatment with Montelukast and nasal corticosteroids and after treatment with azalastine and nasal corticosteroids and nasal corticosteroids alone with SNOT22; 3)Evaluation the effect of each treatment on the control of underlying asthma, if exists
Design
Three groups of 22 patients with moderate to severe allergic rhinitis were divided into three groups based on the clinic file number. Phase 3 clinical trial was performed to evaluate the effectiveness of each treatment.
Settings and conduct
This study is performed on patients referred to the Allergy Clinic of Imam Reza Clinic in Shiraz. First, patients' information is recorded and then the SNOT22 questionnaire is filled in by them. Depending on the intervention group, treatment is started and the forms are filled out again within three months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) age of patients under 6 years and over 50 years old; 2) moderate to severe allergic rhinitis.
Exclusion criteria: 1) drug allergy; 2) infectious rhinitis; 3) patients with chronic diseases; 4) taking other drugs and immunotherapy
Intervention groups
The first group consisted of 22 patients will receive montelukast and budesonide nasal spray .The second group with 22 patients will receive intranasal antihistamines (Azelastine) with a dose of one puff twice a day for patients between 6 and 12 years and two puffs twice a day for patients older than 12 years and a nasal spray and budsonide. The third group consisted of 22 patients will use only the intranasal corticosteroid budesonide.
Main outcome variables
Patients' quality of life (SNOT22 questionnaire score), spirometry variables in case of asthma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200906048642N1
Registration date:2020-09-16, 1399/06/26
Registration timing:registered_while_recruiting
Last update:2020-09-16, 1399/06/26
Update count:0
Registration date
2020-09-16, 1399/06/26
Registrant information
Name
Nasrin Mortazavi Far
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4334
Email address
nasrinmortazavi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of montelukast and intranasal antihistamine in treatment of moderate to severe allergic rhinitis in Shiraz Emam Reza Clinic in 2020
Public title
Comparison of montelukast and intranasal antihistamine in allergic rhinitis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate to severe allergic rhinitis
Seasonal and perennial allergic rhinitis
Exclusion criteria:
Mild or intermittent allergic rhinitis
Chronic diseases under treatment(chronic kidney disease,hypertension,diabetes mellitus)
History of drug reaction
Immunotherapy
Infectious rhinosinusitis
Age
From 6 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
According to clinic reception number, the patients divided respectively to two intervention and one control group
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 Shiraz University of Medical Sciences
Street address
Shiraz university of Medical Science, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2020-07-20, 1399/04/30
Ethics committee reference number
IR.SUMS.MED.REC.1399.242
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
Quality of life via SNOT22
Timepoint
Monthly up to 3 months
Method of measurement
SNOT22 questionnaire
Secondary outcomes
1
Description
Patient symptoms
Timepoint
Monthly to 3 months
Method of measurement
SNOT22 questionnaire
Intervention groups
1
Description
Intervention group: Treatment group with Montelukast and Budesonide nasal spray in this group consisting of 22 patients.Montelukast Dr.Abidi factory with a dose of 5 mg per day to patients aged 6 to 14 years and 10 mg per day to patients older than 14 years and budesonide nasal spray twice a day, one puff is prescribed for patients over 6years and once a day, one intranasal puff to patients aged6-14 years. Treatment lasts for three months. The patient's symptoms are checked monthly.
Category
Treatment - Drugs
2
Description
Intervention group: Azelastine nasal spray and budesonide nasal spray. Treatment group with azalastine nasal spray and budesonide nasal spray with 22patients receiving intranasal antihistamine (Azelastine) with a dose of one puff twice a day for patients between 6 to 12 years and two puffs twice a day for patients older than 12 years and budsonide nasal spray is prescribed. Azalastine (Zelex ) spray produced by World Health Pharmaceutical Company, which was prescribed for three months of treatment.
Category
Treatment - Drugs
3
Description
Control group: nasal spray budesonide (Naxonella spray 64 micrograms / dose 120 puffs) which is administered two puff intranasal twice daily for older than 12years and for6-12 years twice daily one puff intranasally. Standard treatment for moderate to severe allergic rhinitis is nasal corticosteroid spray which in this study is budesonide and the same dose is used in all groups.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza clinic of Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Mortazavi Far
Street address
Imam Reza Clinic, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 2127 0000
Email
motahari@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezayian Zade
Street address
Shiraz University of Medical Science ,Zand street,Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?