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Macrolide Antibiotic

Azithromycin for Wheezing in Preschoolers (AZ-SWED Trial)

Phase 3
Recruiting
Led By Charlie Casper, PhD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 months to <60 months
The presence of expiratory wheezing as ascertained by a physician or nurse practitioner at admission to the ED
Must not have
Suspected foreign body induced aspiration during the last 2 weeks
Presence of acute infection that requires systemic antibiotics, as determined by the physician
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours after randomization
Awards & highlights
Pivotal Trial

Summary

This trial tests if giving preschool children with severe wheezing a medicine called Azithromycin can reduce their symptoms. The study includes children with and without certain bacteria in their noses. The goal is to see if the medicine helps by reducing bacterial infections or improving wheezing overall. Azithromycin has been studied for its potential to reduce severe asthma symptoms, with mixed results in different patient groups.

Who is the study for?
This trial is for preschool children aged 18 months to under 60 months who are experiencing a severe wheezing episode and have been assessed at the emergency department. They must not have used antibiotics or steroids for wheezing in the past two weeks, among other health criteria.
What is being tested?
The AZ-SWED study tests if Azithromycin (12 mg/kg/day for 5 days) helps improve severe wheezing episodes in young children compared to a placebo. The effect is measured using daily caregiver reports and follow-up visits, with some focus on bacterial presence.
What are the potential side effects?
While specific side effects aren't listed here, common ones from Azithromycin may include stomach upset, diarrhea, nausea, vomiting and potential allergic reactions. Monitoring during the trial will assess any complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 59 months old.
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A doctor or nurse heard wheezing when I breathed out during my ED visit.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I may have inhaled a foreign object in the last 2 weeks.
Select...
I am currently on antibiotics for an acute infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours after randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours after randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Asthma
Secondary study objectives
Length of Stay
Azithromycin

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Treatment - ActiveActive Control1 Intervention
Eligible patients will be randomly assigned to one of two treatment groups (1:1) and one arm will be administered the active drug per the randomization schedule. Study medication will be provided to parents/guardians, along with instructions, for home-based administration. The first dose of the study medication will be administered before discharge from the ED.
Group II: Treatment - PlaceboPlacebo Group1 Intervention
Eligible patients will be randomly assigned to one of two treatment groups (1:1) and one arm will be administered placebo per the randomization schedule. Study medication will be provided to parents/guardians, along with instructions, for home-based administration. The first dose of the study medication will be administered before discharge from the ED.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Azithromycin, a macrolide antibiotic, treats asthma by inhibiting bacterial protein synthesis, reducing airway inflammation, and decreasing mucus secretion. It achieves this by binding to the 50S ribosomal subunit of bacteria, blocking their ability to produce proteins necessary for growth. Additionally, azithromycin has anti-inflammatory properties that inhibit neutrophil recruitment and cytokine secretion, which are crucial in reducing airway reactivity and remodeling. This is particularly important for asthma patients as it helps manage severe wheezing episodes and prevents exacerbations. Other common asthma treatments include inhaled corticosteroids, which reduce inflammation, and bronchodilators, which relax airway muscles to improve breathing. These treatments collectively help control asthma symptoms, improve lung function, and enhance the quality of life for patients.
Azithromycin influences airway remodeling in asthma via the PI3K/Akt/MTOR/HIF-1α/VEGF pathway.Azithromycin inhibits mucus hypersecretion from airway epithelial cells.Azithromycin blocks neutrophil recruitment in Pseudomonas endobronchial infection.

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
536 Previous Clinical Trials
158,464 Total Patients Enrolled
9 Trials studying Asthma
2,106 Patients Enrolled for Asthma
University of UtahOTHER
1,141 Previous Clinical Trials
1,696,318 Total Patients Enrolled
5 Trials studying Asthma
175,031 Patients Enrolled for Asthma
Emory UniversityOTHER
1,700 Previous Clinical Trials
2,603,122 Total Patients Enrolled
12 Trials studying Asthma
1,444 Patients Enrolled for Asthma

Media Library

Azithromycin (Macrolide Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04669288 — Phase 3
Asthma Research Study Groups: Treatment - Active, Treatment - Placebo
Asthma Clinical Trial 2023: Azithromycin Highlights & Side Effects. Trial Name: NCT04669288 — Phase 3
Azithromycin (Macrolide Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04669288 — Phase 3
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