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evaluate efficacy of intranasal Montelukast on the outcome of asthma attack in children

A randomized Clinical trial to evaluate efficacy of intranasal Montelukast on the outcome of asthma attack in 2-12years old children

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220119053760N2
Enrollment
68
Registered
2022-12-28
Start date
2022-12-22
Completion date
Unknown
Last updated
2023-02-07

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

Conditions

Severe asthma attack. Severe persistent asthma

Interventions

Intervention 1: Intervention group: Intranasal Montelukast drug using Montelukast powder from Aldrich Company, carboxymethyl cellulose as a suspending agent, methylparaben and propylparaben as antimic

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Morteza Sadi Nejad

Esfahan University of Medical Sciences

n.abrishami@hlth.mui.ac.ir+98 913 787 7646

Outcome results

None listed

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