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Comparison of the effectiveness of intranasal budesonide, oral montelukast and their combination in patients with allergic rhinitis

Protocol summary

Study aim
Determination and comparison of the effectiveness of intranasal budesonide, oral montelukast and their combination in patients with allergic rhinitis
Design
Three parallel group randomized trial, phase 2-3 on 135 patients. Random allocation software was used for randomization.
Settings and conduct
This study will be performed on patients referred to the ENT clinic of hospitals affiliated to Isfahan University of Medical Sciences with the criteria of allergic rhinitis in the SFAR questionnaire. Individuals are randomly divided into three groups: treatment with budesonide nasal spray, treatment with montelukast tablets, and combination therapy. All patients before, 3 weeks, 6 weeks and 12 weeks after starting treatment are evaluated and compared in terms of symptom severity by VAS and SNOT22 questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having allergic rhinitis and age over 15 years; Exclusion criteria: smoking, pregnancy, asthma, nasal polyps, severe nasal deviation, nasal tumor or mass, sinusitis, receiving any treatment for allergic rhinitis within a week before admission, severe underlying disease, and having Churg-Strauss
Intervention groups
A group treated with intranasal budesonide spray (1 puff of spray 64 micrograms per nose, morning and evening; a total of 256 micrograms per day); The other group was treated with montelukast tablets (1 tablet of montelukast 10 mg daily, in the evening) and the last group received combination therapy with budesonide spray (1 puff of spray 64 micrograms per nose, in the morning only; a total of 128 micrograms per day). In addition, they will receive montelukast tablets (1 montelukast tablet 10 mg in the evening).
Main outcome variables
Runny nose score, Sneezing score, Nasal congestion score, Nasal itching score, Complications

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171030037093N41
Registration date: 2020-11-01, 1399/08/11
Registration timing: prospective

Last update: 2020-11-01, 1399/08/11
Update count: 0
Registration date
2020-11-01, 1399/08/11
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-10, 1399/08/20
Expected recruitment end date
2021-05-15, 1400/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of intranasal budesonide, oral montelukast and their combination in patients with allergic rhinitis
Public title
Effect of budesonide, montelukast and their combination in allergic rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having allergic rhinitis Age over 15 years
Exclusion criteria:
smoking Pregnancy Asthma Nasal polyps Severe nasal deviation Nasal tumor or mass Sinusitis Get any treatment for allergic rhinitis within a week before the visit Existence of severe underlying disease Having Churg-Strauss
Age
From 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 135
Randomization (investigator's opinion)
Randomized
Randomization description
Patients included in the study are randomly assigned into three groups using Random allocation computer software with the simple method.
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 Isfahan University of Medical Sciences
Street address
Isfahn University of Medical Sciences, Hezar Jarib st, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2020-10-12, 1399/07/21
Ethics committee reference number
IR.MUI.MED.REC.1399.596

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
Runny nose score
Timepoint
Before intervention, 3 weeks, 6 weeks and 12 weeks after treatment
Method of measurement
Visual Analogue Scale and Sino-nasal Outcome Test questionnaires

2

Description
Sneezing score
Timepoint
Before intervention, 3 weeks, 6 weeks and 12 weeks after treatment
Method of measurement
Visual Analogue Scale and Sino-nasal Outcome Test questionnaires

3

Description
Nasal congestion score
Timepoint
Before intervention, 3 weeks, 6 weeks and 12 weeks after treatment
Method of measurement
Visual Analogue Scale and Sino-nasal Outcome Test questionnaires

4

Description
Itchy nose score
Timepoint
Before intervention, 3 weeks, 6 weeks and 12 weeks after treatment
Method of measurement
Visual Analogue Scale and Sino-nasal Outcome Test questionnaires

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: treated with budesonide nasal spray by Jaber Ibn Hayyan Company (1 puff of spray 64 micrograms per nose, morning and evening; a total of 256 micrograms per day) for 3 months
Category
Treatment - Drugs

2

Description
Second intervention group: treated with montelukast tablets produced by Tehran Daru company (1 montelukast tablet 10 mg in the evening) for 3 months
Category
Treatment - Drugs

3

Description
Third intervention group: under combination treatment with budesonide spray by Jaber Ibn Hayyan (1 puff of spray 64 micrograms per nose, only in the morning; a total of 128 micrograms per day) plus montelukast tablets produced by Tehran Daroo Company (1 montelukast tablets 10 mg in the evening) for 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Ahmad Rezaeian
Street address
Al-Zahra Hospital, Sofeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
dr.ahmadrezaeian@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Rezaeian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Isfahan University Of Medical Science, Hezar Jerib Avenue, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7539
Email
dr.ahmadrezaeian@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Rezaeian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Isfahan University Of Medical Science, Hezar Jerib Avenue, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7539
Email
dr.ahmadrezaeian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Rezaeian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Isfahan University Of Medical Science, Hezar Jerib Avenue, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7539
Email
dr.ahmadrezaeian@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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 5 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Al-Zahra Hospital, Dr. Ahmad Rezaeian - dr.ahmadrezaeian@gmail.com
What processes are involved for a request to access data/document
After the investigation of the researcher request and presentation of required documents will be accessible.
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