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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 belowSelect...
I am between 18 and 59 months old.
Select...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours after randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours after randomization
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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your Pediatric Respiratory Assessment Measurement (PRAM) score was 4 or higher at any point during the emergency room visit.Criterion: You have a long-term illness or condition that could affect your ability to participate in the study, such as seizures, developmental delays, or chronic lung disease. You have certain heart problems, were born prematurely, or have a history of certain medical procedures. You have certain allergies, are currently involved in another medical study, or cannot speak English or Spanish.I am between 18 and 59 months old.I have taken antibiotics in the last 2 weeks.I have used steroids for wheezing in the last 2 weeks.I may have inhaled a foreign object in the last 2 weeks.A doctor or nurse heard wheezing when I breathed out during my ED visit.I am currently on antibiotics for an acute infection.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment - Active
- Group 2: Treatment - Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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