Objectives: The study aimed to determine the effect of montelukast on clinical symptoms of children with asthma compared with inhaled steroids
Design: In this randomized double-blind clinical trial, after explaining the study and obtaining informed consent from patients, 100 eligible subjects were selected through convenience sampling and then fell into intervention group (a) and active control group (B) by randomized block design. The block size will be considered to be 4. Group A will receive conventional drug (inhaled steroids). Group B will receive montelukast.
Methodology: Every treatment period takes 3 months. The dosage of montelukast is one capsule daily in healthy subjects. A questionnaire consisted of two parts is used to collect data. The first part is related to demographic characteristics (gender, age, education level, etc.) and the second part is related to the patient's condition and clinical symptoms which are collected using standard questionnaires VAS and ChildACT. This questionnaire will be filled in at zero time, at the end of the first month, at the end of the second month and at the end of the third month (actually, the answers to the questionnaire VAS as scoring from 0 to 10 will be weekly provided). Asthma severity and the control of asthma symptoms will be assessed according to GINA recommendations. Participants included children of 4-11 years old with asthma according to GINA criterion
Interventions: giving montelukast to the patients
Main consequences: patients’ clinical symptoms
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050723046N3
Registration date:2017-05-31, 1396/03/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-31, 1396/03/10
Registrant information
Name
Mehdi Gholamzadeh Baeis
Name of organization / entity
Qom Branch Of Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 61 3391 8586
Email address
dr.m.gholamzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Qom Branch Of Islamic Azad University
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of montelukast compared with inhaled steroids on clinical symptoms in children with asthma in 2017
Public title
The effect of montelukast compared with inhaled steroids on clinical symptoms in children with asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 4-11 years old; having asthma (according to GINA criterion); patients with mild persistent asthma (according to GINA criterion).
Exclusion criteria: any medical disease that affects the study results, such as Bacterial or Viral Infections of the Respiratory Tract and uncontrolled asthma (peak expiratory flow<20%); taking antibiotics during the month before entering the study; non-compliance of taking drug: the participants’ compliance will be determined from the number of montelukasts not taken at the end of each month (montelukast has been taken for more than 24 days per month).
Age
From 4 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Qom branch of Islamic Azad University
Street address
School of Medicine, Islamic Azad University, 15 Khordad street, Qom
City
Qom
Postal code
Approval date
2016-11-27, 1395/09/07
Ethics committee reference number
IR.IAU.Qom.REC.1395.37
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Clinical signs asthma(cough, wheezing, dyspnea)
Timepoint
efore intervention, the end of the first month, the end of second month, the end of the third month
Method of measurement
According to GINA questionnaire and Child ACT
Secondary outcomes
1
Description
Severe of Asthma
Timepoint
Before intervention, the end of the first month, the end of second month, the end of the third month
Method of measurement
According to need for treatment as recommended by GINA
Intervention groups
1
Description
The intervention group: Take the medication montelukast to patients. Each treatment period of 3 months. Drug dosage is one capsule daily.
Category
Treatment - Drugs
2
Description
Control group: an inhaled steroid drugs to patients. Each treatment period of 3 months. Two puffs daily drug dosage
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gulpaigani Hospital
Full name of responsible person
Mehdi Gholamzadeh Baeis
Street address
Hospital Gulpaigani, Motahari Square
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Of Qom Branch Of Islamic Azad University
Full name of responsible person
Dr Mohammad Javad Qasemzadeh
Street address
School of Medicine, Islamic Azad University, 15 Khordad street, Qom
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Of Qom Branch Of Islamic Azad University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qom Branch Of Islamic Azad University
Full name of responsible person
Mehdi Gholamzadeh Baeis
Position
Student Of M.D
Other areas of specialty/work
Street address
School of Medicine, Islamic Azad University, 15 Khordad street, Qom
City
Qom
Postal code
Phone
+98 25 3280 8080
Fax
Email
Dr.M.Gholamzadeh@Gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qom Branch Of Islamic Azad University
Full name of responsible person
Dr Mohammad Javad Qasemzadeh
Position
Pediatrician
Other areas of specialty/work
Street address
School of Medicine, Islamic Azad University, 15 Khordad street, Qom
City
Qom
Postal code
Phone
+98 25 3280 8080
Fax
Email
Qasemzade.M@Gmail.Com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qom Branch Of Islamic Azad University
Full name of responsible person
Mehdi Gholamzadeh Baeis
Position
Student Of M.D
Other areas of specialty/work
Street address
School of Medicine, Islamic Azad University, 15 Khordad street, Qom
City
Qom
Postal code
Phone
+98 25 3280 8080
Fax
Email
Dr.M.Gholamzadeh@Gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)