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Could a common antibiotic ease severe wheezing in young children?

NCT ID NCT04669288

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study investigates whether a 5-day course of oral azithromycin can reduce wheezing severity in preschool children (18 months to under 5 years) who come to the emergency department with a severe wheezing episode. Children are randomly assigned to receive either azithromycin or a placebo, and parents track symptoms daily using a validated diary. The goal is to see if the antibiotic improves recovery and reduces the need for further medical care.

What this could mean

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

Active substance
azithromycin
What this could lead to
If effective, azithromycin could become a standard short-term treatment to ease severe wheezing episodes in young children, reducing symptoms and hospital stays.
What could go wrong
This is a Phase 3 trial, but results may vary by child. Azithromycin is an antibiotic, so overuse could contribute to resistance, and it may not work for all wheezing causes.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

840 people

The number who actually took part.

Started

Nov 2021

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 60 months

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 18 months to \<60 months. * The presence of expiratory wheezing as ascertained by a physician or nurse practitioner at admission to the ED. * A Pediatric Respiratory Assessment Measurement (PRAM) score of greater than or equal to 4 at any time during the ED admission. Exclusion Criteria: * Presence of acute infection that requires systemic antibiotics, as determined by the physician. * Current or previous use of systemic antibiotics within the last 2 weeks. * Current or previous use of a steroid for wheezing within the last 2 weeks. * Suspected foreign body induced aspiration during the last 2 weeks. * A known systemic illness (other than allergy) including but not limited to: * Recurrent seizures * Gastroesophageal reflux (GER) requiring medical treatment * Major congenital anomalies * Physical and intellectual delay * Cerebral palsy * A history of chest surgery * Tuberculosis or other chronic infections * Primary or secondary immunodeficiency * Gastrointestinal malformation or disease * Cardiac disorder (except for a hemodynamically insignificant atrial septal defect (ASD), ventricular septal defect (VSD) or benign heart murmur) * Born at less than 36 weeks estimated gestational age. * Received oxygen for more than 5 days in the neonatal period, or received invasive mechanical ventilation. * Significant developmental delay / failure to thrive, defined as a child plotting less than 3rd percentile. * Any chronic lung disease. * The study intervention poses undue risk to patient in the opinion of the treating physician * Known sensitivity or allergy to AZ. * Participation in the evaluation of a drug or medical device currently or within the last 30 days. * Previous enrollment into this trial. * Inability of the parent or guardian to speak English or Spanish. * Positive PCR or antigen test for COVID-19 from hospital/doctor's office/testing center within the past 30 days.

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Conditions

The condition(s) this trial relates to.

asthma Respiratory Sounds

As listed by the trial registrant

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

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Healthcare of Atlanta, Emory University

    Atlanta, Georgia, 30322, United States

  • Children's Hospital of New York Medical Center

    New York, New York, 10032, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • The Children's Hospital of Philadelphia (CHOP)

    Philadelphia, Pennsylvania, 19104, United States

  • The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

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