Acetaminophen Versus Ibuprofen in Children With Asthma

NCT01606319 | Completed Phase 3 Results DMC

• 2 other identifiers: AsthmaNet 0051U10HL098115
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Asthma; Wheezing

Keywords

Asthma; Wheezing; Ibuprofen; Acetaminophen; exacerbations; pain; fever

Outcome Measures

Primary Outcomes (1)

• Exacerbation Frequency

  the number of asthma exacerbations requiring systemic corticosteroids

  last 46 weeks of 48 week treatment period

Secondary Outcomes (3)

• Asthma Control Days

  last 46 weeks of 48 week treatment period

• Asthma Rescue Medication Use

  last 46 weeks of 48 week treatment period

• Health Care Utilization

  last 46 weeks of 48 week treatment period

Study Arms (2)

acetaminophen

EXPERIMENTAL

acetaminophen given as needed for pain or fever

Drug: Acetaminophen

ibuprofen

EXPERIMENTAL

ibuprofen given as needed for pain or fever

Drug: Ibuprofen

Interventions

Acetaminophen DRUG

15 mg/kg every 6 hours as needed

Also known as: tylenol, paracetamol

acetaminophen

Ibuprofen DRUG

9.4 mg/kg every 6 hours as needed

Also known as: motrin, advil, nonsteroidal anti-inflammatory drug

ibuprofen

Eligibility Criteria

• Age: 12 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (15)

University of Arizona College of Medicine

Tucson, Arizona, 85724, United States

Location

Children's Hospital & Research Center Oakland

Oakland, California, 94609, United States

Location

UCSF Benioff Children's Hospital

San Francisco, California, 94143, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Rush University Medical Center/Stroger Hospital

Chicago, Illinois, 60612, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Children's Hospital, Boston

Boston, Massachusetts, 02115, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

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

Cleveland, Ohio, 44106, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Sheehan WJ, Mauger DT, Paul IM, Moy JN, Boehmer SJ, Szefler SJ, Fitzpatrick AM, Jackson DJ, Bacharier LB, Cabana MD, Covar R, Holguin F, Lemanske RF Jr, Martinez FD, Pongracic JA, Beigelman A, Baxi SN, Benson M, Blake K, Chmiel JF, Daines CL, Daines MO, Gaffin JM, Gentile DA, Gower WA, Israel E, Kumar HV, Lang JE, Lazarus SC, Lima JJ, Ly N, Marbin J, Morgan WJ, Myers RE, Olin JT, Peters SP, Raissy HH, Robison RG, Ross K, Sorkness CA, Thyne SM, Wechsler ME, Phipatanakul W; NIH/NHLBI AsthmaNet. Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma. N Engl J Med. 2016 Aug 18;375(7):619-30. doi: 10.1056/NEJMoa1515990.

  PMID: 27532828 DERIVED

MeSH Terms

Conditions

Asthma; Respiratory Sounds; Pain; Fever

Interventions

Acetaminophen; Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Body Temperature Changes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Results Point of Contact

• Title: David Mauger, PhD
• Organization: Penn State University Dept of Public Health Sciences

dmauger@psu.edu

717.573.0336

Study Officials

• William B Busse, MD

  University of Wisconsin, Madison

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, AsthmaNet Data Coordinating Center

Study Record Dates

• First Submitted: May 23, 2012
• First Posted: May 25, 2012
• Study Start: February 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 16, 2017
• Results First Posted: January 16, 2017

Record last verified: 2016-11

Locations

US (15)