Asthma AVICA Study – Phase III

Acetaminophen Versus Ibuprofen in Children with Asthma

Protocol Description

The purpose of this multi-center study is to find out if acetaminophen (for example, Tylenol) or ibuprofen (for example, Motrin) might be related to asthma symptoms in young children when it is used for relieving pain or reducing fever. Researchers believe it is possible that medications used to treat fever and/or body aches may work differently in young children with asthma, and that those differences might depend on the treatment the child receives for asthma control.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, the study is accepting preschool children of both genders, ages 1 through 4, who have been diagnosed with asthma.
Boys and Girls: Ages 12 to 59 months (1 through 4 years of age)

Note: Participation in this study requires simultaneous participation in the INFANT study.

Participating children will be randomly assigned to receive either acetaminophen or ibuprofen administered as needed per parental decision for fever and/or pain relief during the study period. Parents will be required to keep a medication log. A 2- to 8-week “run-in” (trial) period will precede the 48-week test period to help with participant qualification.
Visits: 8
Duration: 50-56 weeks

Status: Open to Enrollment

Source(s) of Support
National Heart, Lung and Blood Institute (NHLBI)

Additional Resources
Study Description at National Institutes of Health

Primary Investigator(s)

Fernando Holguin, MD

Contact Information

For information or to enroll, please contact the Pulmonary Research team at 1-877-296-9026.

Last Update
April 21, 2014
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Last Update
April 21, 2014