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IRCT20230930059560N1 IRCT 2024-01-17 Shahre-kord University of Medical Sciences 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) 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) 2024-01-21 anticipated 100 Complete https://irct.ir/trial/73469 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Hyperreactiv airway disease. Intervention 1: 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). Intervention 2: Control group: including 50 children aged 2 to 15 with HRAD diagnosis receiving standard treatment (including short-acting beta-agonist spray (salbutamol), antihistamine (cetirizine)). Yes - There is a plan to make this available What will be shared: 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 access period will start 6 months after the results are published. To whom: Our data will only be available to researchers working in academic and scientific institutions Conditions: 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. Where to obtain: 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 How to obtain: 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. Comments:
public Sadegh Khalilian Shalamzari
Parastar Street, Hajar Shahrekord Hospital
Shahrekord Iran (Islamic Republic of) ۸۸۱۵۷۱۳۴۷۱ +98 38 3222 0016 st-khalilian@skums.ac.ir Shahre-kord University of Medical Sciences scientific Sadegh Khalilian Shalamzari
Parastar Street, Hajar Hospital
Shahrekord Iran (Islamic Republic of) ۸۸۱۵۷۱۳۴۷۱ +98 38 3222 0016 st-khalilian@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 2 years 15 years Both patient with known asthma Other diagnoses such as pneumonia are relevant Recent treatment with systemic or inhaled corticosteroids J70.9 Respiratory conditions due to unspecified external agent Treatment - Drugs Treatment - Drugs 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) Control group: including 50 children aged 2 to 15 with HRAD diagnosis receiving standard treatment (including short-acting beta-agonist spray (salbutamol), antihistamine (cetirizine)) 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. 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. 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. 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. 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. 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. 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. Shahre-kord University of Medical Sciences Approved 2023-10-16 Ethics committee of Shahrekord University of Medical Sciences Parastar Ave, Shahrekord Hajar Hospital Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)