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J Allergy Clin Immunol. 2016 Dec;138(6):1608-1618.e12. doi: 10.1016/j.jaci.2016.09.028. Epub 2016 Oct 21.

Individualized therapy for persistent asthma in young children.

Author information

1
Emory University, Department of Pediatrics, Atlanta, GA.
2
University of Wisconsin School of Medicine and Public Health, Pediatrics Section of Allergy, Immunology and Rheumatology, Madison, WI.
3
Penn State University, College of Medicine, Department of Public Health Sciences, Hershey, PA.
4
Boston Children's Hospital, Division of Allergy/Immunology, Harvard Medical School, Boston, MA.
5
Stroger Hospital of Cook County, Department of Pediatrics, Rush University Medical Center, Chicago, IL.
6
Penn State University, College of Medicine, Department of Pediatrics, Hershey, PA.
7
Washington University in St. Louis School of Medicine and St. Louis Children's Hospital, Department of Pediatrics. St Louis, MO.
8
University of California - San Francisco, Medicine, San Francisco, CA.
9
The University of Pittsburgh Asthma Institute at UPMC/UPSOM, Pittsburgh, PA.
10
University of Wisconsin School of Medicine and Public Health, Pediatrics, Madison, WI.
11
University of Arizona, Arizona Respiratory Center, Tuscon, AZ.
12
Ann & Robert H Lurie Children's Hospital of Chicago, Chicago, IL.
13
Washington University School of Medicine and St. Louis Children's Hospital, Department of Pediatrics. St Louis, MO.
14
University of California San Francisco Benioff Children's Hospital Oakland, Oakland, CA.
15
Nemours Children's Health System, Jacksonville, FL.
16
Department of Pediatrics, Case Western Reserve University School of Medicine, Rainbow Babies and Children's Hospital, Cleveland, OH.
17
National Jewish Health, Pediatrics, Denver, CO.
18
University of Arizona, Arizona Respiratory Center, Tucson, AZ.
19
Boston Children's Hospital, Division of Respiratory Diseases, Harvard Medical School, Boston, MA.
20
Allegheny General Hospital, Department of Pediatrics, Pittsburgh, PA.
21
Wake Forest School of Medicine, Winston-Salem, NC.
22
Brigham & Women's Hospital, Harvard Medical School, Boston, MA.
23
University of Illinois at Chicago, Chicago, IL.
24
Nemours Children's Hospital, University of Central Florida College of Medicine, Orlando, FL.
25
University of California, San Francisco, Medicine, San Francisco, CA.
26
University of California - San Francisco, Airway Clinical Research Center, San Francisco, CA.
27
University of California San Francisco Benioff Children's Hospital Oakland, Oakland CA.
28
Rainbow Babies and Children's Hospital, Cleveland, OH.
29
National Jewish Health, Department of Pediatrics, Denver, CO.
30
Wake Forest University School of Medicine, Winston-Salem, NC.
31
University of New Mexico, Pediatrics / Pulmonary, Albuquerque, NM.
32
University of Wisconsin-Madison, Madison, WI.
33
Olive View-UCLA Medical Center, Department of Pediatrics, David Geffen School of Medicine at UCLA, Los Angeles, CA.
34
Children's Hospital Colorado, The Breathing Institute, and University of Colorado School of Medicine, Aurora, CO.
#
Contributed equally

Abstract

BACKGROUND:

Phenotypic presentations in young children with asthma are varied and might contribute to differential responses to asthma controller medications.

METHODS:

The Individualized Therapy for Asthma in Toddlers study was a multicenter, randomized, double-blind, double-dummy clinical trial in children aged 12 to 59 months (n = 300) with asthma necessitating treatment with daily controller (Step 2) therapy. Participants completed a 2- to 8-week run-in period followed by 3 crossover periods with daily inhaled corticosteroids (ICSs), daily leukotriene receptor antagonists, and as-needed ICS treatment coadministered with albuterol. The primary outcome was differential response to asthma medication based on a composite measure of asthma control. The primary analysis involved 2 stages: determination of differential response and assessment of whether 3 prespecified features (aeroallergen sensitization, previous exacerbations, and sex) predicted a differential response.

RESULTS:

Seventy-four percent (170/230) of children with analyzable data had a differential response to the 3 treatment strategies. Within differential responders, the probability of best response was highest for a daily ICS and was predicted by aeroallergen sensitization but not exacerbation history or sex. The probability of best response to daily ICS was further increased in children with both aeroallergen sensitization and blood eosinophil counts of 300/μL or greater. In these children daily ICS use was associated with more asthma control days and fewer exacerbations compared with the other treatments.

CONCLUSIONS:

In young children with asthma necessitating Step 2 treatment, phenotyping with aeroallergen sensitization and blood eosinophil counts is useful for guiding treatment selection and identifies children with a high exacerbation probability for whom treatment with a daily ICS is beneficial despite possible risks of growth suppression.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01606306.

KEYWORDS:

Asthma; asthma biomarkers; asthma phenotype; asthma treatment; inhaled corticosteroid; leukotriene receptor antagonist; personalized medicine; treatment response

PMID:
27777180
PMCID:
PMC5148729
DOI:
10.1016/j.jaci.2016.09.028
[Indexed for MEDLINE]
Free PMC Article

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