What side effects are associated with this type of intervention?

Common treatments for asthma, particularly those involving antibiotics like azithromycin, can have several side effects. Azithromycin, a macrolide antibiotic, is generally well-tolerated but can cause gastrointestinal disturbances such as diarrhea, nausea, and abdominal pain. Other potential side effects include allergic reactions, which may manifest as skin rashes or, in rare cases, anaphylaxis. Long-term use of azithromycin has been associated with an increased risk of antibiotic resistance and potential cardiac issues, such as QT prolongation, which can lead to arrhythmias. It is important for patients to discuss these potential side effects with their healthcare provider to ensure the benefits outweigh the risks.

What prior FDA approvals exist?

The FDA has approved various treatments for asthma, including bronchodilators, corticosteroids, and biologics. While azithromycin, an antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, is not primarily used for asthma, it has been studied for its potential benefits in respiratory conditions due to its anti-inflammatory properties. Other FDA-approved treatments for asthma include inhaled corticosteroids like budesonide, long-acting beta-agonists such as salmeterol, and biologics like omalizumab, which target specific pathways in the inflammatory process of asthma.

What other types of research exist?

Promising alternatives to Azithromycin for asthma patients include Clarithromycin and Dirithromycin, which are macrolides with similar mechanisms of action. Additionally, Pristinamycin, a streptogramin, has shown efficacy against respiratory pathogens and could be a useful alternative. These antibiotics have been studied for their effectiveness in treating respiratory infections and may offer benefits for asthma patients.

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Macrolide Antibiotic

Azithromycin for Wheezing in Preschoolers (AZ-SWED Trial)

Q: What is the mechanism of action of this treatment?

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.

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

Select...

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

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.

0 / 4Eligibility criteria met

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.