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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)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230930059560N1
Enrollment
100
Registered
2024-01-17
Start date
2024-01-21
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperreactiv airway disease. Respiratory conditions due to unspecified external agent

Interventions

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

Sponsors

Shahre-kord University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 15 Years

Inclusion 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

Exclusion criteria: patient with known asthma Other diagnoses such as pneumonia are relevant Recent treatment with systemic or inhaled corticosteroids

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSadegh Khalilian Shalamzari

Shahre-kord University of Medical Sciences

st-khalilian@skums.ac.ir+98 38 3222 0016

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026