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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01606319
Other study ID # AsthmaNet 005
Secondary ID 1U10HL098115
Status Completed
Phase Phase 3
First received May 23, 2012
Last updated March 11, 2016
Start date February 2013
Est. completion date April 2015

Study information

Verified date March 2016
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 12 Months to 59 Months
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Acetaminophen
15 mg/kg every 6 hours as needed
Ibuprofen
9.4 mg/kg every 6 hours as needed

Locations

Country Name City State
United States Emory University Atlanta Georgia
United States Children's Hospital Boston Boston Massachusetts
United States Children's Hospital, Boston Boston Massachusetts
United States University of Virginia Health System Charlottesville Virginia
United States Children's Memorial Hospital Chicago Illinois
United States Rush University Medical Center/Stroger Hospital Chicago Illinois
United States Rainbow Babies and Children's Hospital, Case Western Reserve University Cleveland Ohio
United States National Jewish Health Denver Colorado
United States University of Wisconsin-Madison Madison Wisconsin
United States Children's Hospital & Research Center Oakland Oakland California
United States Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania
United States UCSF Benioff Children's Hospital San Francisco California
United States St. Louis Children's Hospital St. Louis Missouri
United States University of Arizona College of Medicine Tucson Arizona
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Milton S. Hershey Medical Center National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary exacerbation frequency the number of asthma exacerbations requiring systemic corticosteroids 48 week treatment period No
Secondary asthma control days proportion of study days on which asthma was controlled, measured by electronic diary 48 week treatment period No
Secondary asthma rescue medication use average albuterol rescue use per week, measured by electronic diary 48 week treatment period No
Secondary health care utilization frequency of unscheduled physician visits, emergency department visits or hospitalizations for asthma 48 week treatment period No
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