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Montelukast effect in the prevention of respiratory infections

Comparison of Montelukast and placebo in the prevention of upper respiratory infections in children 1 to 5 years

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012103111339N1
Enrollment
380
Registered
2012-12-06
Start date
2012-11-21
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Common cold. Acute nasopharyngitis [common cold]

Interventions

Intervention 1: In this randomized, double-blind study 190 children from 1 to 5 years old referred to Pediatric Clinic of arak Amir Kabir Hospital from 21/11/2012 to 19/2/2013 who do not have hyper re
Prevention
In this randomized, double-blind study 190 children from 1 to 5 years old referred to Pediatric Clinic of arak Amir Kabir Hospital from 21/11/2012 to 19/2/2013 who do not have hyper reactive airway di

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 5 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Lack of hyper reactive airway disease;No history of allergic rhinitis;Not taking any medication for a chronic;Absence of chronic heart disease or chronic respiratory disease: Exclusion criteria Hyper reactive airway disease (previously treated with bronchodilators in the last three months, Or more than once treatment in the past year or hospitalization for treatment or prophylaxis in recent years with Monteluckast or steroids);History of allergic rhinitis;Taking any medication for a chronic; Chronic heart disease or chronic respiratory disease;Known hypersensitivity to Montelukast;Active URI within one week ago

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Number of uri attacks. Timepoint: Weekly to 12 weeks. Method of measurement: Call and complete symptom checklist.

Secondary

MeasureTime frame
Otitis media, Pneumonia, Tonsillitis, Pharyngitis. Timepoint: Weekly to 12 weeks. Method of measurement: Call and complete symptom cheklist.;The number of weeks that a child has a fever. Timepoint: Weekly to 12 weeks. Method of measurement: Call and complete symptom cheklist.;The use of antibiotics or anti-fever. Timepoint: Weekly to 12 weeks. Method of measurement: Call and complete symptom cheklist.;Doctor visits. Timepoint: Weekly to 12 weeks. Method of measurement: Call and complete symptom cheklist.;Absences from child care. Timepoint: Weekly to 12 weeks. Method of measurement: Call and complete symptom cheklist.;Absent parents. Timepoint: Weekly to 12 weeks. Method of measurement: Call and complete symptom cheklist.;Hospitalization. Timepoint: Weekly to 12 weeks. Method of measurement: Call and complete symptom cheklist.;Drug reaction. Timepoint: Weekly to 12 weeks. Method of measurement: Call and complete symptom cheklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Fatemeh Dorreh

Arak University of Medical Sciences

esmaelie.m@arakmu.ac.ir+98 86 1313 5075

Outcome results

None listed

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