Asthma outcomes: Biomarkers

Stanley J. Szefler; Sally Wenzel; Robert Brown; Serpil C. Erzurum; John V. Fahy; Robert G. Hamilton; John F. Hunt; Hirohito Kita; Andrew H. Liu; Reynold A. Panettieri; Robert P. Schleimer; Michael Minnicozzi

doi:10.1016/j.jaci.2011.12.979

Asthma outcomes: Biomarkers

Stanley J. Szefler, Sally Wenzel, Robert Brown, Serpil C. Erzurum, John V. Fahy, Robert G. Hamilton, John F. Hunt, Hirohito Kita, Andrew H. Liu, Reynold A. Panettieri, Robert P. Schleimer, Michael Minnicozzi^*

^*Corresponding author for this work

Medicine, Allergy Division

Research output: Contribution to journal › Article › peer-review

327 Scopus citations

Abstract

Background: Measurement of biomarkers has been incorporated within clinical research studies of asthma to characterize the population and associate the disease with environmental and therapeutic effects. Objective: National Institutes of Health institutes and federal agencies convened an expert group to propose which biomarkers should be assessed as standardized asthma outcomes in future clinical research studies. Methods: We conducted a comprehensive search of the literature to identify studies that developed and/or tested asthma biomarkers. We identified biomarkers relevant to the underlying disease process progression and response to treatment. We classified the biomarkers as either core (required in future studies), supplemental (used according to study aims and standardized), or emerging (requiring validation and standardization). This work was discussed at an National Institutes of Health-organized workshop convened in March 2010 and finalized in September 2011. Results: Ten measures were identified; only 1, multiallergen screening to define atopy, is recommended as a core asthma outcome. Complete blood counts to measure total eosinophils, fractional exhaled nitric oxide (Feno), sputum eosinophils, urinary leukotrienes, and total and allergen-specific IgE are recommended as supplemental measures. Measurement of sputum polymorphonuclear leukocytes and other analytes, cortisol measures, airway imaging, breath markers, and system-wide studies (eg, genomics, proteomics) are considered as emerging outcome measures. Conclusion: The working group participants propose the use of multiallergen screening in all asthma clinical trials to characterize study populations with respect to atopic status. Blood, sputum, and urine specimens should be stored in biobanks, and standard procedures should be developed to harmonize sample collection for clinical trial biorepositories.

Original language	English (US)
Pages (from-to)	S9-S23
Journal	Journal of Allergy and Clinical Immunology
Volume	129
Issue number	3 SUPPL.
DOIs	https://doi.org/10.1016/j.jaci.2011.12.979
State	Published - Mar 2012

Funding

The Asthma Outcomes workshop was funded by contributions from the National Institute of Allergy and Infectious Diseases; the National Heart, Lung, and Blood Institute; the Eunice Kennedy Shriver National Institute of Child Health and Human Development; the National Institute of Environmental Health Sciences; the Agency for Healthcare Research and Quality; and the Merck Childhood Asthma Network , as well as by a grant from the Robert Wood Johnson Foundation . Contributions from the National Heart, Lung, and Blood Institute; the National Institute of Allergy and Infectious Diseases; the Eunice Kennedy Shriver National Institute of Child Health and Human Development; the National Institute of Environmental Health Sciences ; and the US Environmental Protection Agency funded the publication of this article and all other articles in this supplement.

Keywords

IgE
Multiallergen screen
fractional exhaled nitric oxide
sputum eosinophils
total eosinophils

ASJC Scopus subject areas

Immunology and Allergy
Immunology

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10.1016/j.jaci.2011.12.979

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title = "Asthma outcomes: Biomarkers",

abstract = "Background: Measurement of biomarkers has been incorporated within clinical research studies of asthma to characterize the population and associate the disease with environmental and therapeutic effects. Objective: National Institutes of Health institutes and federal agencies convened an expert group to propose which biomarkers should be assessed as standardized asthma outcomes in future clinical research studies. Methods: We conducted a comprehensive search of the literature to identify studies that developed and/or tested asthma biomarkers. We identified biomarkers relevant to the underlying disease process progression and response to treatment. We classified the biomarkers as either core (required in future studies), supplemental (used according to study aims and standardized), or emerging (requiring validation and standardization). This work was discussed at an National Institutes of Health-organized workshop convened in March 2010 and finalized in September 2011. Results: Ten measures were identified; only 1, multiallergen screening to define atopy, is recommended as a core asthma outcome. Complete blood counts to measure total eosinophils, fractional exhaled nitric oxide (Feno), sputum eosinophils, urinary leukotrienes, and total and allergen-specific IgE are recommended as supplemental measures. Measurement of sputum polymorphonuclear leukocytes and other analytes, cortisol measures, airway imaging, breath markers, and system-wide studies (eg, genomics, proteomics) are considered as emerging outcome measures. Conclusion: The working group participants propose the use of multiallergen screening in all asthma clinical trials to characterize study populations with respect to atopic status. Blood, sputum, and urine specimens should be stored in biobanks, and standard procedures should be developed to harmonize sample collection for clinical trial biorepositories.",

keywords = "IgE, Multiallergen screen, fractional exhaled nitric oxide, sputum eosinophils, total eosinophils",

author = "Szefler, {Stanley J.} and Sally Wenzel and Robert Brown and Erzurum, {Serpil C.} and Fahy, {John V.} and Hamilton, {Robert G.} and Hunt, {John F.} and Hirohito Kita and Liu, {Andrew H.} and Panettieri, {Reynold A.} and Schleimer, {Robert P.} and Michael Minnicozzi",

note = "Funding Information: The Asthma Outcomes workshop was funded by contributions from the National Institute of Allergy and Infectious Diseases; the National Heart, Lung, and Blood Institute; the Eunice Kennedy Shriver National Institute of Child Health and Human Development; the National Institute of Environmental Health Sciences; the Agency for Healthcare Research and Quality; and the Merck Childhood Asthma Network , as well as by a grant from the Robert Wood Johnson Foundation . Contributions from the National Heart, Lung, and Blood Institute; the National Institute of Allergy and Infectious Diseases; the Eunice Kennedy Shriver National Institute of Child Health and Human Development; the National Institute of Environmental Health Sciences ; and the US Environmental Protection Agency funded the publication of this article and all other articles in this supplement. ",

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AU - Szefler, Stanley J.

AU - Wenzel, Sally

AU - Brown, Robert

AU - Erzurum, Serpil C.

AU - Fahy, John V.

AU - Hamilton, Robert G.

AU - Hunt, John F.

AU - Kita, Hirohito

AU - Liu, Andrew H.

AU - Panettieri, Reynold A.

AU - Schleimer, Robert P.

AU - Minnicozzi, Michael

N1 - Funding Information: The Asthma Outcomes workshop was funded by contributions from the National Institute of Allergy and Infectious Diseases; the National Heart, Lung, and Blood Institute; the Eunice Kennedy Shriver National Institute of Child Health and Human Development; the National Institute of Environmental Health Sciences; the Agency for Healthcare Research and Quality; and the Merck Childhood Asthma Network , as well as by a grant from the Robert Wood Johnson Foundation . Contributions from the National Heart, Lung, and Blood Institute; the National Institute of Allergy and Infectious Diseases; the Eunice Kennedy Shriver National Institute of Child Health and Human Development; the National Institute of Environmental Health Sciences ; and the US Environmental Protection Agency funded the publication of this article and all other articles in this supplement.

PY - 2012/3

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N2 - Background: Measurement of biomarkers has been incorporated within clinical research studies of asthma to characterize the population and associate the disease with environmental and therapeutic effects. Objective: National Institutes of Health institutes and federal agencies convened an expert group to propose which biomarkers should be assessed as standardized asthma outcomes in future clinical research studies. Methods: We conducted a comprehensive search of the literature to identify studies that developed and/or tested asthma biomarkers. We identified biomarkers relevant to the underlying disease process progression and response to treatment. We classified the biomarkers as either core (required in future studies), supplemental (used according to study aims and standardized), or emerging (requiring validation and standardization). This work was discussed at an National Institutes of Health-organized workshop convened in March 2010 and finalized in September 2011. Results: Ten measures were identified; only 1, multiallergen screening to define atopy, is recommended as a core asthma outcome. Complete blood counts to measure total eosinophils, fractional exhaled nitric oxide (Feno), sputum eosinophils, urinary leukotrienes, and total and allergen-specific IgE are recommended as supplemental measures. Measurement of sputum polymorphonuclear leukocytes and other analytes, cortisol measures, airway imaging, breath markers, and system-wide studies (eg, genomics, proteomics) are considered as emerging outcome measures. Conclusion: The working group participants propose the use of multiallergen screening in all asthma clinical trials to characterize study populations with respect to atopic status. Blood, sputum, and urine specimens should be stored in biobanks, and standard procedures should be developed to harmonize sample collection for clinical trial biorepositories.

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KW - sputum eosinophils

KW - total eosinophils

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Asthma outcomes: Biomarkers

Abstract

Funding

Keywords

ASJC Scopus subject areas

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