Acetaminophen Versus Ibuprofen in Children With Asthma
Condition: Asthma; Wheezing
MeSH terms: Asthma; Respiratory Sounds
Intervention: Acetaminophen; Ibuprofen
Intervention description: 15 mg/kg every 6 hours as needed; 9.4 mg/kg every 6 hours as needed
Intervention MeSH terms: Acetaminophen; Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 12 Months
Maximum age: 59 Months
Healthy volunteers: No
Keywords: Asthma; Wheezing; Ibuprofen; Acetaminophen; exacerbations; pain; fever

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.
    

Eligibility 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.