Could a common antibiotic ease severe wheezing in young children?
NCT ID NCT04669288
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.
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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
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840 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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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
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18 to 60 months
- Sex
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Boston Children's Hospital
Boston, Massachusetts, 02115, United States
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Children's Healthcare of Atlanta, Emory University
Atlanta, Georgia, 30322, United States
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Children's Hospital of New York Medical Center
New York, New York, 10032, United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
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The Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, 19104, United States
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The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
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University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
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