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.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 4 Weeks to 2 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Pakistan Institute of Medical Sciences Government |
| Locations | 1 site (Islamabad, Federal) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | August 18, 2026 |
| Trial ID | NCT07770464 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.