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Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing

Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing in Infants 3 to 12 Months of Age in Bandar Abbas Children' Hospital

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01370187
Enrollment
146
Registered
2011-06-09
Start date
2010-07-31
Completion date
2011-06-30
Last updated
2011-06-14

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

Conditions

Bronchiolitis, Cough, Wheezing

Keywords

Bronchiolitis, Postbronchiolitis wheezing, Montelukast

Brief summary

The aim of the current study is to evaluate the effect of Montelukast in treatment of acute bronchiolitis and postbronchiolitis viral induced wheezing of infants 3 to 12 months of age in Bandar Abbas Children' hospital.

Detailed description

All the patients will be evaluated at the baseline, during hospitalization (daily) and at 2 months and 6 months after starting the intervention.

Interventions

DRUGMontelukast

Montelukast 4mg daily for 2 months

Sponsors

Hormozgan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Months to 12 Months
Healthy volunteers
No

Inclusion criteria

* infant in 3-12 months of age with first episode of wheezing or bronchiolitis * written informed consent by parents

Exclusion criteria

* Previous wheezing episode or confirmed asthma or bronchiolitis * recent bronchodilator use * immune deficient * immunosuppressive drug use * croup or pneumonia diagnosis * loss of follow up

Design outcomes

Primary

MeasureTime frameDescription
Respiratory Distress Severity Score (RDSS)participants will be followed for the duration of hospital stay, an expected average of 3 daysRDSS is measured by wheezing (0, 1, 2)+ Cough (0, 1, 2)+Retraction (0, 1,2)+Respiratory rate(0,1,2)+ Oxygen saturation(0,1,2) scores

Secondary

MeasureTime frameDescription
average number of cough daily= as expressed parents during visits6 monthsnone= No cough, Mild=less than 10 daily, Severe=More than 10 daily
Wheezing severity in the physical examination by physician6 MonthsNone= no wheezing, Mild= mild expiratory, Severe= inspiratory and expiratory

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026