Acetaminophen Versus Ibuprofen in Children With Asthma (AVICA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01606319
First received: May 23, 2012
Last updated: July 10, 2014
Last verified: July 2014
  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.


Condition Intervention Phase
Asthma
Wheezing
Drug: Acetaminophen
Drug: Ibuprofen
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

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • exacerbation frequency [ Time Frame: 48 week treatment period ] [ Designated as safety issue: No ]
    the number of asthma exacerbations requiring systemic corticosteroids


Estimated Enrollment: 294
Study Start Date: February 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: acetaminophen
acetaminophen given as needed for pain or fever
Drug: Acetaminophen
15 mg/kg every 6 hours as needed
Other Names:
  • tylenol
  • paracetamol
Experimental: ibuprofen
ibuprofen given as needed for pain or fever
Drug: Ibuprofen
9.4 mg/kg every 6 hours as needed
Other Names:
  • motrin
  • advil
  • nonsteroidal anti-inflammatory drug

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

Ages Eligible for Study:   12 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arizona
University of Arizona College of Medicine
Tucson, Arizona, United States, 85724
United States, California
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94609
UCSF Benioff Children's Hospital
San Francisco, California, United States, 94143
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
Rush University Medical Center/Stroger Hospital
Chicago, Illinois, United States, 60612
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Children's Hospital, Boston
Boston, Massachusetts, United States, 02115
United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Rainbow Babies and Children's Hospital, Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Study Chair: William B Busse, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: dave mauger, Principal Investigator, AsthmaNet Data Coordinating Center, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01606319     History of Changes
Other Study ID Numbers: AsthmaNet 005, 1U10HL098115
Study First Received: May 23, 2012
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Milton S. Hershey Medical Center:
Asthma
Wheezing
Ibuprofen
Acetaminophen
exacerbations
pain
fever

Additional relevant MeSH terms:
Asthma
Respiratory Sounds
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Acetaminophen
Ibuprofen
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 10, 2014