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Evaluating the Efficacy of oral Montelukast in 5-14 year old children hospitalized with severe exacerbated asthma

Evaluating the Efficacy of oral Montelukast in 5-14 year old children hospitalized with severe exacerbated asthma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251021067707N1
Enrollment
72
Registered
2025-10-25
Start date
2025-11-22
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Severe Exacerbation of Asthma. Severe Exacerbation of Asthma

Interventions

Intervention 1: Intervention group: Routine treatment regimen for moderate to severe asthma plus montelukast 5 mg orally/day. Intervention 2: Control group: Control group: Routine moderate to severe a

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 14 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Length of hospital stay. Timepoint: The entire length of hospital stay. Method of measurement: Hospital file.;The need for adjunctive therapies such as magnesium sulfate. Timepoint: The entire length of hospital stay. Method of measurement: Hospital file.

Secondary

MeasureTime frame
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.;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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeed Choupani

Oroumia University of Medical Sciences

schoopany1373@gmail.com+98 44 4625 4148

Outcome results

None listed

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