Individualized therapy for persistent asthma in young children

National Institutes of Health/National Heart, Lung, and Blood Institute AsthmaNet

Research output: Contribution to journalArticle

70 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1608-1618.e12
JournalJournal of Allergy and Clinical Immunology
Volume138
Issue number6
DOIs
StatePublished - Dec 1 2016

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Asthma
Adrenal Cortex Hormones
Therapeutics
Eosinophils
Leukotriene Antagonists
Albuterol
History
Clinical Trials
Growth

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Immunology

Cite this

National Institutes of Health/National Heart, Lung, and Blood Institute AsthmaNet (2016). Individualized therapy for persistent asthma in young children. Journal of Allergy and Clinical Immunology, 138(6), 1608-1618.e12. https://doi.org/10.1016/j.jaci.2016.09.028
National Institutes of Health/National Heart, Lung, and Blood Institute AsthmaNet. / Individualized therapy for persistent asthma in young children. In: Journal of Allergy and Clinical Immunology. 2016 ; Vol. 138, No. 6. pp. 1608-1618.e12.
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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.",
author = "{National Institutes of Health/National Heart, Lung, and Blood Institute AsthmaNet} and Fitzpatrick, {Anne M.} and Jackson, {Daniel J.} and David Mauger and Boehmer, {Susan J.} and Wanda Phipatanakul and Sheehan, {William J.} and Moy, {James N.} and Ian Paul and Bacharier, {Leonard B.} and Cabana, {Michael D.} and Ronina Covar and Fernando Holguin and Lemanske, {Robert F.} and Martinez, {Fernando D.} and Pongracic, {Jacqueline A.} and Avraham Beigelman and Baxi, {Sachin N.} and Mindy Benson and Kathryn Blake and Chmiel, {James F.} and Daines, {Cori L.} and Daines, {Michael O.} and Gaffin, {Jonathan M.} and Gentile, {Deborah Ann} and Gower, {W. Adam} and Elliot Israel and Kumar, {Harsha Vardhan} and Lang, {Jason E.} and Lazarus, {Stephen C.} and Lima, {John J.} and Ngoc Ly and Jyothi Marbin and Wayne Morgan and Myers, {Ross E.} and Olin, {J. Tod} and Peters, {Stephen P.} and Raissy, {Hengameh H.} and Robison, {Rachel G.} and Kristie Ross and Sorkness, {Christine A.} and Thyne, {Shannon M.} and Szefler, {Stanley J.}",
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National Institutes of Health/National Heart, Lung, and Blood Institute AsthmaNet 2016, 'Individualized therapy for persistent asthma in young children', Journal of Allergy and Clinical Immunology, vol. 138, no. 6, pp. 1608-1618.e12. https://doi.org/10.1016/j.jaci.2016.09.028

Individualized therapy for persistent asthma in young children. / National Institutes of Health/National Heart, Lung, and Blood Institute AsthmaNet.

In: Journal of Allergy and Clinical Immunology, Vol. 138, No. 6, 01.12.2016, p. 1608-1618.e12.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Individualized therapy for persistent asthma in young children

AU - National Institutes of Health/National Heart, Lung, and Blood Institute AsthmaNet

AU - Fitzpatrick, Anne M.

AU - Jackson, Daniel J.

AU - Mauger, David

AU - Boehmer, Susan J.

AU - Phipatanakul, Wanda

AU - Sheehan, William J.

AU - Moy, James N.

AU - Paul, Ian

AU - Bacharier, Leonard B.

AU - Cabana, Michael D.

AU - Covar, Ronina

AU - Holguin, Fernando

AU - Lemanske, Robert F.

AU - Martinez, Fernando D.

AU - Pongracic, Jacqueline A.

AU - Beigelman, Avraham

AU - Baxi, Sachin N.

AU - Benson, Mindy

AU - Blake, Kathryn

AU - Chmiel, James F.

AU - Daines, Cori L.

AU - Daines, Michael O.

AU - Gaffin, Jonathan M.

AU - Gentile, Deborah Ann

AU - Gower, W. Adam

AU - Israel, Elliot

AU - Kumar, Harsha Vardhan

AU - Lang, Jason E.

AU - Lazarus, Stephen C.

AU - Lima, John J.

AU - Ly, Ngoc

AU - Marbin, Jyothi

AU - Morgan, Wayne

AU - Myers, Ross E.

AU - Olin, J. Tod

AU - Peters, Stephen P.

AU - Raissy, Hengameh H.

AU - Robison, Rachel G.

AU - Ross, Kristie

AU - Sorkness, Christine A.

AU - Thyne, Shannon M.

AU - Szefler, Stanley J.

PY - 2016/12/1

Y1 - 2016/12/1

N2 - 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.

AB - 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.

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U2 - 10.1016/j.jaci.2016.09.028

DO - 10.1016/j.jaci.2016.09.028

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National Institutes of Health/National Heart, Lung, and Blood Institute AsthmaNet. Individualized therapy for persistent asthma in young children. Journal of Allergy and Clinical Immunology. 2016 Dec 1;138(6):1608-1618.e12. https://doi.org/10.1016/j.jaci.2016.09.028