Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 4 Weeks to 2

Montelukast for acute bronchiolitis in infants and young children

Official title: Evaluating The Role Of Montelukast In Management Of Acute Bronchiolitis

Run by Pakistan Institute of Medical Sciences · NCT07770464 · Data updated 2026-11-12

This study tests whether adding montelukast to standard care helps shorten hospital stays and relieve symptoms in indoor patients aged 4 weeks to 2 years with acute bronchiolitis.

More Bronchiolitis trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages4 Weeks to 2 Years
SexAll
Enrollment60 (estimated)
SponsorPakistan Institute of Medical Sciences
Government
Locations1 site (Islamabad, Federal)
StatusRecruiting
StartedJanuary 1, 2026
Main results expectedSeptember 30, 2026
Study endsSeptember 30, 2026
Registry record updatedAugust 18, 2026
Trial IDNCT07770464 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are hospitalized children aged 4 weeks to 2 years with acute bronchiolitis of less than 4 days duration, without asthma history or congenital heart disease and not currently on asthma medications.

Probably not a fit

Children with asthma history, prior respiratory hospitalizations, congenital heart disease, immunodeficiency, or radiographic pneumonia may derive less or no benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial compares montelukast to placebo in children aged 4 weeks to 2 years with acute bronchiolitis. Eligible participants must have symptom duration less than 4 days and meet clinical criteria for bronchiolitis without prior asthma or significant comorbidities. The study aims to determine if montelukast can shorten admission duration and improve clinical symptoms compared with placebo. Outcomes will be assessed during hospitalization and may inform future management strategies for acute bronchiolitis. The trial is conducted at the Pakistan Institute of Medical Sciences in Islamabad, led by the same institution.

Why it matters

Potential benefit: If successful, montelukast could shorten hospital stays and improve symptom relief for infants and toddlers with acute bronchiolitis.

How similar studies have gone: Previous trials outside this specific setting have explored leukotriene modifiers in bronchiolitis with mixed results, making this investigation relatively novel in its exact design.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Pakistan Institute of Medical Sciences, Islamabad
    Islamabad, Federal, Pakistan
    Recruiting

Study contacts

  • Principal investigator: Dr Haniyah Anwar — Pakistan Institute of Medical Sciences
  • Study coordinator: Dr Haniyah Anwar, M.B.B.S
  • Email: haniyahanwar@yahoo.com
  • Phone: +92334-8359647

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.