evaluate efficacy of intranasal Montelukast on the outcome of asthma attack in 2-12years old children
Design
A community-based, practice-oriented, parallel-group, single-blind, randomized controlled clinical trial
Settings and conduct
The samples were selected as available method at Imam Hossein Hospital of Isfahan. Then, completely randomly and based on the children's national number, using spss software, they were randomly assigned to two intervention and placebo groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Children 2 to 12 years old
Hospitalization due to an acute asthma attack with a pulmonary index score between 7 and 11 (moderate attack) and a score greater than 12 (severe attack)
Exclusion Criteria:
Simultaneous treatment with systemic corticosteroids or antileukotrienes within 4 weeks before admission
Other possible causes for the patient's symptoms such as pneumonia
Having a history of chronic lung diseases and anatomical airway problems and congenital heart disease
History of taking anticonvulsant and immunosuppressive drugs
Intervention groups
In the intervention group, the intranasal Montelukast drug using Montelukast powder from Aldrich Company, carboxymethyl cellulose as a suspending agent, methylparaben and propylparaben as antimicrobial and antifungal preservatives and phosphate buffer to adjust ph by a pharmaceutical specialist It was prepared clinically in the laboratory of the Faculty of Pharmacy of Isfahan University of Medical Sciences and was given to the patient in the form of a fixed dose intranasal spray in a special package. In the placebo group, the drug package containing all the ingredients of the original formula except Montelukast and in the same packaging was used.
Main outcome variables
The severity of the asthma attack
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220119053760N2
Registration date:2022-12-28, 1401/10/07
Registration timing:registered_while_recruiting
Last update:2022-12-28, 1401/10/07
Update count:0
Registration date
2022-12-28, 1401/10/07
Registrant information
Name
Neda Abrishami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 8089
Email address
n.abrishami@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized Clinical trial to evaluate efficacy of intranasal Montelukast on the outcome of asthma attack in 2-12years old children
Public title
evaluate efficacy of intranasal Montelukast on the outcome of asthma attack in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 2 to 12 years old
Hospitalization due to an acute asthma attack with a pulmonary index score (PIS) between 7 and 11 (moderate attack) or a score greater than 12 (severe attack)
Exclusion criteria:
Simultaneous treatment with systemic corticosteroids or antileukotrienes within 4 weeks before admission
Other possible causes for the patient's symptoms such as pneumonia
Having a history of chronic lung diseases and anatomical airway problems and congenital heart disease
History of taking anticonvulsant and immunosuppressive drugs
Age
From 2 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were selected as available from Imam Hossein Hospital of Isfahan. Then, completely randomly and based on the children's national number, using spss software, they were randomly assigned to two intervention and placebo groups. After the child entered the hospital, if the entry and exit criteria were met, the children's national number was registered in the software and by choosing the exact ratio of 50% of the children, they were assigned to two randomized groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Both groups received the standard drug. In the intervention group, in addition to the standard drug, montelukast nasal was used, and in the placebo group, placebo was used in the same amount and the same appearance of the drug.
Placebo
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
Isfahan University of Medical Sciences , Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-05-11, 1401/02/21
Ethics committee reference number
IR.MUI.MED.REC.1401.190
Health conditions studied
1
Description of health condition studied
Severe asthma attack
ICD-10 code
J45.5
ICD-10 code description
Severe persistent asthma
Primary outcomes
1
Description
The severity of the asthma attack
Timepoint
On the first day of hospitalization, every 4 hours and on the following days of hospitalization, once a day, patients based on PIS score (pulmonary index score)
Method of measurement
According to the reference, a moderate attack is defined based on the need for auxiliary oxygen-nebulizer albuterol and systemic glucocorticoid, and a severe attack is defined based on the need for auxiliary oxygen-nebulizer salbutamol and ipratropium-systemic glucocorticoid-magnesium sulfate.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intranasal Montelukast drug using Montelukast powder from Aldrich Company, carboxymethyl cellulose as a suspending agent, methylparaben and propylparaben as antimicrobial and antifungal preservatives and phosphate buffer to adjust ph by a clinical pharmacy specialist in the faculty laboratory. Pharmacy of Isfahan University of Medical Sciences is prepared and given to the patient in a special package as a spray with a fixed dose inside the nose. The drug is used once a day.
Category
Treatment - Drugs
2
Description
Control group: The combination of carboxymethyl cellulose as a suspending agent, methyl paraben and propyl paraben as an antimicrobial and antifungal preservative and a phosphate buffer to adjust pH was prepared by a clinical pharmacy specialist in the laboratory of the Faculty of Pharmacy of Isfahan University of Medical Sciences and packaged in a special spray form. It is given to the patient with a fixed intranasal dose. The drug is used once a day.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Dr. Morteza Sadi Nejad
Street address
Imam Khomeini street
City
Isfahan
Province
Isfehan
Postal code
3759153111
Phone
+98 31 5631 0619
Email
n.abrishamy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Vice Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
research@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
Dr. Morteza Sadi Nejad
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam Hossein Children's Hospital, Imam Khomeini St
City
Isfahan
Province
Isfehan
Postal code
3759153111
Phone
+98 913 787 7646
Email
n.abrishami@hlth.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Neda Abrishami
Position
Student
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Isfahan University of Medical Sciences, School of Medicine
City
Isfahan
Province
Isfehan
Postal code
817671111
Phone
+98 31 3778 8089
Fax
Email
n.abrishami@hlth.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Neda Abrishami
Position
Student
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Isfahan University of Medical Sciences, School of Medicine
City
Isfahan
Province
Isfehan
Postal code
817671111
Phone
+98 31 3778 8089
Fax
Email
n.abrishami@hlth.mui.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
Information and data will be available to applicants one year after obtaining the results.
When the data will become available and for how long
Information and data will be available to applicants one year after obtaining the results.
To whom data/document is available
Doctors
Under which criteria data/document could be used
Comparison of new drug combination with another new drug
From where data/document is obtainable
Send a message to dean@med.mui.ac.ir
What processes are involved for a request to access data/document