CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 300 enrolled
Drug / intervention
Acetaminophen +1 moredrug
Likely dose
Acetaminophen 15 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/NCT01606319
NCT01606319Phase 3Completed
CompareCT.gov

Acetaminophen vs. Ibuprofen in Children With Asthma

Milton S. Hershey Medical Center·interventional·Posted May 25, 2012·Updated Jan 16, 2017

In Brief

A Phase 3 clinical trial evaluating Acetaminophen and Ibuprofen for Asthma and Wheezing. Completed, enrolled 300 participants across 15 sites.

Detailed Summary

The Acetaminophen Versus Ibuprofen in Children with Asthma study will test the primary hypothesis that in preschool children 12-59 months of age with persistent asthma on standardized asthma therapy, the number of asthma exacerbations requiring systemic corticosteroids will be more frequent in children randomized to receive acetaminophen as compared to those randomized to receive ibuprofen on an as needed basis for fevers and pain.

Study Details

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

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 25, 2012
Enrollment StartFeb 1, 2013
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.1 years ago

Interventions

Acetaminophendrug

15 mg/kg every 6 hours as needed

Ibuprofendrug

9.4 mg/kg every 6 hours as needed