Investigating the effect of early montelukast use on the need for hospitalization, duration of hospitalization and clinical symptoms in children aged 2 to 15 years with the diagnosis of Hyperreactiv Airway Disease (HRAD)
Determining the effect of early use of Montelukast on the need for hospitalization, duration of hospitalization and clinical symptoms in children aged 2 to 15 years with the diagnosis of airway hyperreactivity
Design
A clinical trial with a control group, with a parallel group, a blind strain, randomized, phase 3 on 100 patients (two groups with 50 samples). Simple randomization method is used for randomization.
Settings and conduct
This research is a one-sided blind clinical study with random sampling on children aged 2 to 15 with HRAD referring to Asthma and Allergy Clinic of Imam Ali Clinic and selected patients admitted to the Pediatric Department of Hajar Shahrekord Hospital in 1402. .
The intervention group will receive standard treatment in addition to Montelukast and the control group will receive standard treatment. Standard treatment includes salbutamol and cetirizine. Then the clinical symptoms, the need for hospitalization and the length of hospitalization of the two groups will be compared.
Participants/Inclusion and exclusion criteria
Occurrence of clinical symptoms of HRAD and its clinical diagnosis by ;pediatric allergy specialist;
Age 2 to 15 years;
Other diagnoses, such as pneumonia, are not mentioned or ruled out;
The patient does not have known asthma;
Intervention groups
The intervention group (including 50 children aged 2 to 15 with HRAD with random selection) receiving standard treatment plus montelukast (airokast 5 mg chewable brand from Abidi Pharmaceutical Company) and the control group (including 50 children aged 2 to 15 with HRAD randomly selected) receiving standard treatment.
Standard treatment includes a short-acting beta-agonist (salbutamol) and an antihistamin (cetirizin).
Main outcome variables
Cough frequency;
Cough severity;
Pulmonary wheeze;
Nocturnal sleep disorder;
Arterial oxygen saturation;
Need to be hospitalized;
Length of hospitalization;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230930059560N1
Registration date:2024-01-17, 1402/10/27
Registration timing:prospective
Last update:2024-01-17, 1402/10/27
Update count:0
Registration date
2024-01-17, 1402/10/27
Registrant information
Name
Sadegh Khalilian Shalamzari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
st-khalilian@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of early montelukast use on the need for hospitalization, duration of hospitalization and clinical symptoms in children aged 2 to 15 years with the diagnosis of Hyperreactiv Airway Disease (HRAD)
Public title
Investigating the effect of early montelukast use on the need for hospitalization, duration of hospitalization and clinical symptoms in children aged 2 to 15 years with the diagnosis of Hyperreactiv Airway Disease (HRAD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with airway hyperreactivity between 2 years and 15 years who have not recently used systemic or inhaled corticosteroids and are not known to have asthma.
Absence of serious diseases that interfere with the research results (such as severe heart or lung diseases).
Has not recently used long-term bronchodilators or theophylline.
Exclusion criteria:
patient with known asthma
Other diagnoses such as pneumonia are relevant
Recent treatment with systemic or inhaled corticosteroids
Age
From 2 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The research samples are divided into the test group and the control group by simple randomization (in this way, based on the patient's arrival time, we prepare the list of patients and consider the even numbers as the test group and the odd numbers as the control group) .
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to blind the study, the data collector, clinical care provider and data analyst will be unaware of whether the patients received montelukast or not.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Parastar Ave, Shahrekord Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۸۵۴۶۳۳
Approval date
2023-10-16, 1402/07/24
Ethics committee reference number
IR.SKUMS.MED.REC.1402.054
Health conditions studied
1
Description of health condition studied
Hyperreactiv airway disease
ICD-10 code
J70.9
ICD-10 code description
Respiratory conditions due to unspecified external agent
Primary outcomes
1
Description
Need to be hospitalized
Timepoint
At the beginning of the study and then every 3 days until the end of 2 weeks
Method of measurement
Clinical examination: pulmonary auscultation with a stethoscope, measurement of arterial oxygen with a pulse oximeter
2
Description
Duration of hospitalization
Timepoint
From the time of admission to the hospital until discharge on a daily basis
Method of measurement
Counting the number of days of hospitalization
Secondary outcomes
1
Description
Cough severity
Timepoint
At the beginning of the study and then every 3 days until the end of 2 weeks
Method of measurement
Based on the scoring system of a standardized 5-question questionnaire
2
Description
Cough frequency
Timepoint
At the beginning of the study and then every 3 days until the end of 2 weeks
Method of measurement
Based on the scoring system of a standardized 5-question questionnaire
3
Description
Nocturnal sleep disorder
Timepoint
At the beginning of the study and then every 3 days until the end of 2 weeks
Method of measurement
Based on the scoring system of a standardized 5-question questionnaire
4
Description
Pulmonary wheezing
Timepoint
At the beginning of the study and then every 3 days until the end of 2 weeks
Method of measurement
Clinical examination: pulmonary auscultation with a stethoscope
5
Description
Arterial oxygen saturation
Timepoint
at the beginning of the research and then every 3 days until the end of 2 weeks
Method of measurement
Clinical examination: measurement of arterial oxygen with a pulse oximeter
Intervention groups
1
Description
Intervention group: including 50 children aged 2 to 15 years with HRAD diagnosis receiving standard treatment (including short-acting beta-agonist spray (salbutamol) and antihistamine (cetirizine)) plus Montelukast (Airokast 5 mg chewable brand from Abidi Pharmaceutical Company)
Category
Treatment - Drugs
2
Description
Control group: including 50 children aged 2 to 15 with HRAD diagnosis receiving standard treatment (including short-acting beta-agonist spray (salbutamol), antihistamine (cetirizine))
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord's specialized and super-specialized Imam Ali clinic
Full name of responsible person
Mohammad Ali Zamani
Street address
Shariati Avenue
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
87954684354
Phone
+98 38 3224 2696
Email
zamani.m@skums.ac.ir
2
Recruitment center
Name of recruitment center
Hajar Shahrekord educational-therapeutic center
Full name of responsible person
Mohammad Ali Zamani
Street address
Parastar Avenue
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 5505
Email
zamani.m@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Raeisi
Street address
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 2414
Email
elhamraeisi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Sadegh Khalilian Shalamzari
Position
Pediatric assistant
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Parastar Street, Hajar Shahrekord Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3222 0016
Fax
Email
st-khalilian@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Sadegh Khalilian Shalamzari
Position
Pediatric assistant
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Parastar Street, Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3222 0016
Fax
Email
st-khalilian@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Sadegh Khalilian Shalamzari
Position
Pediatric assistant
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Parastar Street, Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3222 0016
Fax
Email
st-khalilian@skums.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
To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published.
When the data will become available and for how long
The access period will start 6 months after the results are published.
To whom data/document is available
Our data will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Except for personal information about people, all of our data will be shared if certain requirements are met. Our data will only be used for comparable study and peer review by other researchers. Anyone working in universities or scientific institutions who wants to do similar study or confirm the accuracy of our data can access our data.
From where data/document is obtainable
All qualified individuals can collect data by referring to the project manager in order to acquire information. Contact information is available via email at st-khalilian@skums.ac.ir or the contact number 00989137210665
What processes are involved for a request to access data/document
To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most.