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NCT Number: NCT07770464

Evaluating The Role Of Montelukast In Management Of Acute Bronchiolitis

This study aims to evaluate the role of Montelukast in management of acute Bronchiolitis in indoor patient and how this drug shortens the duration of admission and improves symptoms

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Key information

Conditions

Acute Bronchiolitis

Age range

4 week–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pakistan Institute of Medical Sciences, Islamabad

Islamabad, Federal, 44000, Pakistan

Location status: Recruiting

Location contact

Dr Haniyah Anwar, M.B.B.S

CONTACT

[email protected]

+92334-8359647

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 4 weeks to 2 years
  • Both genders
  • Duration of respiratory symptoms less than 4 days
  • Clinical diagnosis of acute bronchiolitis according to the operational definition provided in the study protocol

Exclusion criteria

  • History of asthma
  • Previous hospital admissions for respiratory illness
  • Use of asthma medications
  • Congenital heart disease
  • Bronchopulmonary dysplasia
  • Immunodeficiency
  • Immunosuppression
  • Radiological evidence of pneumonia, including infiltrates or patches on chest X-ray

Treatment and study plan

Montelukast

Drug

Administrating montelukast to experimental group and monitoring response

Placebo

Drug

Placebo sugar granules administered orally once daily at night according to the same schedule as montelukast 4 mg sachet, in addition to standard supportive care for acute bronchiolitis

Primary outcomes

  1. Change in Clinical Severity Score from Baseline to 72 Hours

    Time frame: Baseline (hospital admission) and 72 hours after initiation of treatment

    Change in the study-defined Clinical Severity Score from baseline at hospital admission to 72 hours after initiation of treatment. The score ranges from 0 to 12 and is calculated from heart rate, wheezing, respiratory rate, dyspnea, respiratory support, and feeding difficulties, with each component scored from 0 to 2. Higher scores indicate greater clinical severity. The change in score will be compared between the montelukast and placebo groups

Secondary outcomes

  1. Length of Hospital Stay

    Time frame: From baseline (hospital admission;day 1) through hospital discharge ( day 7)

    Length of hospital stay measured in hours from hospital admission until hospital discharge. Discharge is defined by resolution of symptoms, including improved feeding, absence of respiratory distress, a clinical severity score less than 3, and respiratory rate within the normal range for age.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Haniyah Anwar, M.B.B.S

CONTACT

[email protected]

+92334-8359647

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Medical Sciences

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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