CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 607 enrolled
Drug / intervention
Azithromycin +3 moredrug
Likely dose
Azithromycin 12 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01272635
NCT01272635Phase 3Completed
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Azithromycin for Preventing the Development of Upper Respiratory Tract Illness Into Lower Respiratory Tract Symptoms in Children and Oral Corticosteroids for Treating Episodes of Significant Lower Respiratory Tract Symptoms in Children

Milton S. Hershey Medical Center·interventional·Posted Jan 10, 2011·Updated Dec 28, 2016

In Brief

A Phase 3 clinical trial evaluating Azithromycin, Prednisolone, and 2 other interventions for Asthma and Wheezing. Completed, enrolled 607 participants across 16 sites.

Detailed Summary

This protocol is comprised of two separate, but linked, clinical trials for treating preschool-aged children with recurrent severe episodes of wheezing. The first study (APRIL) will try to prevent wheezing illness from developing using azithromycin. If a wheezing illness does occur, the second trial (OCELOT) will try to decrease the severity of symptoms using oral corticosteroids.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma, Wheezing
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 10, 2011
Enrollment StartMar 1, 2011
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 15.5 years ago

Interventions

Azithromycindrug

Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day

Prednisolonedrug

Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day

Placebo Azithromycinother

Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day

Placebo Prednisolonedrug

Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day