CLINICAL TRIAL

Acetaminophen Versus Ibuprofen in Children With Asthma

First received on May 23, 2012. Last updated on March 11, 2016.

Purpose

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.

Status Completed

Condition Asthma

Phase Phase 3

Study Type Interventional

Study Design Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention

Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes
Assessor), Primary Purpose: Treatment

Official Title Acetaminophen vs. Ibuprofen in Children With Asthma

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Further study details (as provided by National Institutes of Health Clinical Center (CC))

Enrollment 300

Start Date February 2013

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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.

Eligibility

Minimum Age Eligible for Study: 12 Months

Maximum Age Eligible for Study: 59 Months

Genders Eligible for Study: Both

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Criteria

Inclusion Criteria: - 12-59 months of age. - If the child is not currently taking long-term asthma
controller therapy (meaning that the child has taken no inhaled corticosteroid or leukotriene
receptor antagonist medication whatsoever over the past 6 months), then one of the following
criteria must be met: - Daytime asthma symptoms more than two days per week (average over the
past 4 weeks), - At least one nighttime awakening from asthma (over the past 4 weeks), - Two or
more asthma exacerbations requiring systemic corticosteroids in the previous 6 months, - Four or
more wheezing episodes in the previous 12 months. - If the child is currently taking long-term
asthma controller therapy (meaning that the child has taken daily or intermittent/as-needed inhaled
corticosteroid or leukotriene receptor antagonist over the past 6 months), then one of the following
criteria must be met: - Taking inhaled corticosteroid or leukotriene receptor antagonist for more
than 3 months (or more than 90 days) out of the previous 6 months (or 180 days), - Daytime asthma
symptoms more than two days per week (average over the past 4 weeks), - More than one nighttime
awakening from asthma (over the past 4 weeks), - Two or more asthma exacerbations requiring
systemic corticosteroids in the previous 12 months, - Four or more wheezing episodes in the
previous 12 months. - Up to date with immunizations, including varicella (unless the subject has
already had clinical varicella). - Willingness to provide informed consent by the child's parent or
guardian. Exclusion Criteria: - Allergic reaction to the study medications or any component of the
study drugs, including (but not limited to) urticaria, rash, angioedema, or hypotension following
delivery, - Chronic medical disorders that could interfere with drug metabolism/excretion (for
instance chronic hepatic, biliary, or renal disease), - Chronic medical disorders that may increase the
risk of drug-related injury, including (but not limited to): - Osteogenesis imperfecta (increased risk of
bone demineralization/fracture with corticosteroid therapy), - Crohn's disease, ulcerative colitis,
juvenile rheumatoid arthritis, clotting disorders, or Factor deficiency (increased risk of bleeding with
corticosteroid therapy), - G6PD deficiency (increased risk of hemolytic anemia with acetaminophen
use), - Phenylketonuria (potential for aspartame exposure with study interventions), - Seizure
disorder treated with anticonvulsants (risk of acetaminophen toxicity with carbamazepine), or -
History of clotting disorders or Factor deficiency (increased risk of bleeding with corticosteroids), -
Co-morbid disorders associated with wheezing including (but not limited to) immune deficiency
disorders, cystic fibrosis, aspiration, clinically-relevant gastroesophageal reflux, tracheomalacia,
congenital airway anomalies (clefts, fistulas, slings, rings), bronchiectasis, bronchopulmonary
dysplasia, and/or history of premature birth before 35 weeks gestation, - Significant developmental
delay/failure to thrive, defined as 5th percentile for height and/or weight or crossing of two major
percentile lines during the last year for age and sex, - History of a near-fatal asthma exacerbation
requiring intubation or assisted ventilation, - No primary medical caregiver (e.g., a nurse
practitioner, physician assistant, physician, or group medical practice such as a hospital-based clinic)
whom the subject can contact for primary medical care, - Three or more hospitalizations in the
previous 12 months for wheezing or respiratory illnesses, - Treatment with 5 or more courses of
systemic corticosteroids (oral, intramuscular or intravenous) in the past 6 months, - Current use of
higher than step 2 NAEPP asthma guideline therapy - If receiving allergy shots, change in the dose
within the past 3 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606319

Locations

University of Arizona College of Medicine

Facility: Tucson, Arizona, 85724, United States

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Children's Hospital & Research Center Oakland

Facility: Oakland, California, 94609, United States

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UCSF Benioff Children's Hospital

Facility: San Francisco, California, 94143, United States

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National Jewish Health

Facility: Denver, Colorado, 80206, United States

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Emory University

Facility: Atlanta, Georgia, 30322, United States

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Rush University Medical Center/Stroger Hospital

Facility: Chicago, Illinois, 60612, United States

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Children's Memorial Hospital

Facility: Chicago, Illinois, 60614, United States

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Children's Hospital Boston

Facility: Boston, Massachusetts, 02115, United States

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Children's Hospital, Boston

Facility: Boston, Massachusetts, 02115, United States

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St. Louis Children's Hospital

Facility: St. Louis, Missouri, 63110, United States

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Wake Forest University Health Sciences

Facility: Winston-Salem, North Carolina, 27157, United States

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Rainbow Babies and Children's Hospital, Case Western Reserve University

Facility: Cleveland, Ohio, 44106, United States

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Children's Hospital of Pittsburgh of UPMC

Facility: Pittsburgh, Pennsylvania, 15224, United States

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University of Virginia Health System

Facility: Charlottesville, Virginia, 22908, United States

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University of Wisconsin-Madison

Facility: Madison, Wisconsin, 53792, United States

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Sponsors and Collaborators

Milton S. Hershey Medical Center

More Information
Other Publications

First Received: May 23, 2012

Last Updated: March 11, 2016

ClinicalTrials.gov Identifier: NCT01606319

Health Authority: United States: Institutional Review Board

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ClinicalTrials.gov processed this data on March 17, 2016 Link to the current ClinicalTrials.gov record.

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