NCT01606319

Acetaminophen Versus Ibuprofen in Children With Asthma

Acetaminophen vs. Ibuprofen in Children With Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 12 Months – 59 Months
• Healthy volunteers: Not accepted

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.

Detailed description

AVICA is a 48-week randomized therapeutic trial involving two parallel treatment arms: acetaminophen and ibuprofen. Participating children will be randomized to receive either acetaminophen or ibuprofen administered as needed per parental decision for fever and analgesia. This study will address which is the most appropriate antipyretic-analgesic medication in young children with asthma, and will inform both clinicians and parents seeking to treat children with fever and pain. Given the high frequency of administration of these drugs, this study will have a significant impact on pediatric healthcare regardless of whether a differential effect is discovered as significant uncertainty currently exists as to whether acetaminophen use is associated with increased asthma symptoms.

Conditions

• Asthma
• Wheezing

Interventions

Type	Name	Description
DRUG	Acetaminophen	15 mg/kg every 6 hours as needed
DRUG	Ibuprofen	9.4 mg/kg every 6 hours as needed

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2012-05-25
• Last updated: 2017-01-16
• Results posted: 2017-01-16

Locations

15 sites across 1 country: United States