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Could a common asthma drug shorten bronchiolitis hospital stays?

NCT ID NCT07770464

Disease control Sponsor: Pakistan Institute of Medical Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial tests whether montelukast, a drug used for asthma, can help infants hospitalized with acute bronchiolitis recover faster. About 60 children aged 4 weeks to 2 years will receive either montelukast or a placebo alongside standard care. Researchers will measure changes in symptom severity over 72 hours and how long each child stays in the hospital.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Montelukast, an oral drug that may reduce airway inflammation, given as a 4 mg sachet once daily at night.
What this could lead to
If effective, montelukast could become a standard add-on treatment to shorten hospital stays and speed recovery in infants with bronchiolitis.
What could go wrong
This is a small, early-stage trial, so results may not apply broadly. Montelukast may not improve symptoms or shorten stays, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 weeks to 2 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute bronchiolitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute bronchiolitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Pakistan Institute of Medical Sciences, Islamabad

    RECRUITING

    Islamabad, Federal, 44000, Pakistan

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