Determining the effectiveness of montelukast in children aged 5 to 14 years hospitalized with severe asthma attacks
Design
Controlled clinical trial, with parallel groups, double-blind, randomized, phase 4 on 72 patients. Randomization is performed with ras software.
Settings and conduct
The study will be conducted on children aged 5 to 14 years hospitalized with a severe asthma attack. The design is a randomized, double-blind clinical trial, and patients will be divided into two intervention and control groups. Blinding includes patients and outcome assessors.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 5 to 14 years
Admission with a diagnosis of severe asthma attack
Patients who had a history of salbutamol use in the past two weeks
Diagnosed history of moderate to severe persistent asthma
Not taking montelukast
Exclusion criteria: Lack of parental consent for study entry
Patients who were taking phenytoin, phenobarbital, or rifampicin (due to drug interactions)
Presence of any other possible diagnosis mimicking asthma symptoms
Presence of a clear contraindication to the administration of montelukast
Emergence of serious side effects and drug sensitivity to montelukast
Intervention groups
Patients will be divided into two intervention groups (routine treatment plus montelukast) and control (routine treatment plus placebo). Routine treatment includes oxygen therapy, methylprednisolone, and nebulized Deolin.
Main outcome variables
Primary outcomes: Length of stay; Need for adjuvant therapy.
Secondary outcomes: Drug side effects; Response by triggering agent.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251021067707N1
Registration date:2025-10-25, 1404/08/03
Registration timing:prospective
Last update:2025-10-25, 1404/08/03
Update count:0
Registration date
2025-10-25, 1404/08/03
Registrant information
Name
Saeed choupani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4625 4148
Email address
schoopany1373@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-22, 1404/09/01
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Efficacy of oral Montelukast in 5-14 year old children hospitalized with severe exacerbated asthma
Public title
Evaluating the Efficacy of oral Montelukast in 5-14 year old children hospitalized with severe exacerbated asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 5 to 14 years old
Hospitalized with a diagnosis of severe asthma attack
Patients who have used salbutamol in the past two weeks
A diagnosed history of moderate to severe persistent asthma
Not taking Montelukast
Exclusion criteria:
Parents' lack of consent to participate in the study
Patients who are taking phenytoin, phenobarbital, or rifampicin (due to drug interactions)
The presence of any other possible diagnoses that mimic asthma symptoms
There are clear contraindications for prescribing montelukast.
The occurrence of dangerous side effects and drug allergies to montelukast
Age
From 5 years old to 14 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two intervention groups using Excel software (36 patients, routine treatment regimen for moderate to severe asthma plus montelukast 5 mg orally/daily) and control (36 patients, routine treatment regimen for moderate to severe asthma plus oral placebo/daily).
Blinding (investigator's opinion)
Double blinded
Blinding description
Study participants will be blinded to the placebo, and the outcome assessor will be blinded to the group they are in.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Urmia University of Medical Sciences
Street address
Resalat Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2025-09-24, 1404/07/02
Ethics committee reference number
IR.UMSU.REC.1404.268
Health conditions studied
1
Description of health condition studied
Severe Exacerbation of Asthma
ICD-10 code
J45.51
ICD-10 code description
Severe Exacerbation of Asthma
Primary outcomes
1
Description
Length of hospital stay
Timepoint
The entire length of hospital stay
Method of measurement
Hospital file
2
Description
The need for adjunctive therapies such as magnesium sulfate
Timepoint
The entire length of hospital stay
Method of measurement
Hospital file
Secondary outcomes
1
Description
The occurrence of drug side effects including headache, nausea, diarrhea, and hives
Timepoint
The entire duration of hospitalization
Method of measurement
Taking a patient history
2
Description
Differences in response to treatment based on the type of triggering agent (infectious or non-infectious)
Timepoint
The entire duration of hospitalization
Method of measurement
Taking a patient history
Intervention groups
1
Description
Intervention group: Routine treatment regimen for moderate to severe asthma plus montelukast 5 mg orally/day
Category
Treatment - Drugs
2
Description
Control group: Control group: Routine moderate to severe asthma treatment regimen plus oral/daily placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Hospital, Urmia
Full name of responsible person
Saeed Choupani
Street address
Kashani Crossroads, Kashani Street
City
Urmia
Province
West Azarbaijan
Postal code
5714615463
Phone
+98 44 3223 4897
Email
motahari-h-urm@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saber gholizadeh
Street address
End of Jahad Street
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 1930
Email
research@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Saeed Choupani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No. 2, Kani 5, Kholafayeh Rashedin Boulevard, Andisheh Town
City
Boukan
Province
West Azarbaijan
Postal code
5716114819
Phone
+98 44 4625 4148
Fax
Email
schoopany1373@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saeed Choupani
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No. 2, Kani 5, Kholafayeh Rashedin Boulevard, Andisheh Town
City
Boukan
Province
West Azarbaijan
Postal code
5716114819
Phone
+98 44 4625 4148
Fax
Email
schoopany1373@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saeed Choupani
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No. 2, Kani 5, Kholafayeh Rashedin Boulevard, Andisheh Town
City
Boukan
Province
West Azarbaijan
Postal code
5716114819
Phone
+98 44 4625 4148
Fax
Email
schoopany1373@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