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AsthmaPhase 3AVICANCT01606319

Acetaminophen Versus Ibuprofen in Children With Asthma

A Phase 3 study testing Acetaminophen and Ibuprofen in people with Asthma and Wheezing, run by Milton S. Hershey Medical Center at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 12 to 59 months
Conditions the study is for
Asthma, Wheezing
What is being tested?
Acetaminophen and Ibuprofen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
15 sitesUnited States
Study dates
Feb 2013to Apr 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 59 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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),
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  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Children's Hospital Boston

    Boston, Massachusetts, 02115

  • Children's Hospital, Boston

    Boston, Massachusetts, 02115

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Rush University Medical Center/Stroger Hospital

    Chicago, Illinois, 60612

  • Children's Memorial Hospital

    Chicago, Illinois, 60614

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

    Cleveland, Ohio, 44106

  • National Jewish Health

    Denver, Colorado, 80206

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53792

  • Children's Hospital & Research Center Oakland

    Oakland, California, 94609

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224

  • UCSF Benioff Children's Hospital

    San Francisco, California, 94143

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110

  • University of Arizona College of Medicine

    Tucson, Arizona, 85724

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Acetaminophen vs. Ibuprofen in Children With Asthma

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.

Read the 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.

Conditions
Asthma, Wheezing
Keywords
Asthma, Wheezing, Ibuprofen, Acetaminophen, exacerbations, pain, fever
Medical subject headings
Asthma, Respiratory Sounds, Pain, Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcetaminophenDrug

    Also called tylenol, paracetamol

    15 mg/kg every 6 hours as needed

  • IbuprofenDrug

    Also called motrin, advil, nonsteroidal anti-inflammatory drug

    9.4 mg/kg every 6 hours as needed

Study groups in NCT01606319
Study groupRoleWhat they receive
acetaminophenExperimentalacetaminophen given as needed for pain or fever
Receives: Drug: Acetaminophen
ibuprofenExperimentalibuprofen given as needed for pain or fever
Receives: Drug: Ibuprofen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exacerbation Frequency

    the number of asthma exacerbations requiring systemic corticosteroids

    Measured: last 46 weeks of 48 week treatment period

Secondary outcomes (3)

  1. Asthma Control Days

    proportion of study days on which asthma was controlled, measured by electronic diary

    Measured: last 46 weeks of 48 week treatment period

  2. Asthma Rescue Medication Use

    average albuterol rescue use per week, measured by electronic diary

    Measured: last 46 weeks of 48 week treatment period

  3. Health Care Utilization

    frequency of unscheduled physician visits, emergency department visits or hospitalizations for asthma

    Measured: last 46 weeks of 48 week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2012 (estimated)
  2. Study startFeb 2013
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01606319
Sponsor's protocol ID
AsthmaNet 005
Other IDs
1U10HL098115
Acronym
AVICA
Status last verified
Nov 2016
First submitted
23 May 2012
Last updated
16 Jan 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27532828

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Acetaminophen and Ibuprofen in people with Asthma and Wheezing, run by Milton S. Hershey Medical Center at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exacerbation Frequency (time frame: last 46 weeks of 48 week treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01606319, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.

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