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NCT04669288 · ClinicalTrials.gov registry record · Phase 3
AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department
A Phase 3 study, sponsored by University of Arizona.
- Terminated
- Registry status
- Phase 3
- Development phase
- 840
- Enrollment target
NCT04669288: Clinical Trial Phase 3 study, sponsored by University of Arizona.
NCT04669288 is a Phase 3 study that was terminated before completion, run by University of Arizona. The registered enrollment target is 840 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04669288, a Phase 3 study, was terminated before completion, sponsored by University of Arizona.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 840 participants
- Enrollment target
Study Summary
AZ-SWED is a parallel group, double blind, placebo control efficacy clinical trial with two separate hypotheses. The trial compared the 5-day outcome of preschool children presenting to an Emergency Department (ED) with an acute, severe wheezing episode and treated with either once daily oral Azithromycin (12 mg/kg/day for 5 days) or placebo. The AZ-SWED researchers made separate comparisons in children in whom specific pathogenic bacteria isolated from nasopharyngeal swabs, and in those in whom they were not isolated. The primary outcome was the Asthma Flare-up Diary for Young Children (ADYC), a validated instrument that caregivers will transmit electronically daily after discharge from the ED. Families were contacted daily during the five-day treatment to collect the ADYC, and to assess compliance and complications. A randomly chosen subset of enrolled children participated in two follow-up visits 5-8 days and 14-21 days after visit 1 to assess development of resistance to study drug and treatment response related changes in the airway microbiome.
Primary Outcome
The Asthma Flare-up Diary for Young Children (ADYC) is a validated instrument that consists of a 17-item questionnaire scored from 1 (best) to 7 (worst). The parent or guardian of the enrolled child (up to 60 months of age) filled out the diary daily for 5 days, starting from the first day following the first dose of Azithromycin (AZ). The cumulative score at the end of 5 days was used to assess response to the intervention (e.g. time to exacerbation, acute-care visit, hospitalization and no whe
Interventions
- DRUG Placebo
- DRUG Azithromycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 840 participants |
| Start Date | 2021-11-22 |
| Est. Completion | 2025-01-08 |
| Phase | Phase 3 |
Why NCT04669288 stopped before completion
NCT04669288 is an interventional study that assigns participants to a tested intervention. The registered 840 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04669288 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04669288 about?
NCT04669288 is a clinical study titled "AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department". AZ-SWED is a parallel group, double blind, placebo control efficacy clinical trial with two separate hypotheses. The trial compared the 5-day outcome of preschool children presenting to an Emergency Department (ED) with an acute, severe wheezing episode and treated with either once daily oral Azithr...
What is the current status of trial NCT04669288?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 840 participants. The study started on 2021-11-22. Estimated completion is 2025-01-08.
What interventions are being tested in trial NCT04669288?
The interventions under investigation include: Placebo (DRUG), Azithromycin (DRUG).
Who is sponsoring clinical trial NCT04669288?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04669288's enrollment target sits among peer trials
840 392nd of 2000 higher than 1,607 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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