Asthma outcomes: Biomarkers - 02/03/12
Corresponding author: Michael Minnicozzi, PhD, Division of Allergy, Immunology, and Transplantation (DAIT), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), 6610 Rockledge Drive, Bethesda, MD 20892.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.
Le texte complet de cet article est disponible en PDF.Key words : Multiallergen screen, fractional exhaled nitric oxide, sputum eosinophils, total eosinophils, IgE, urinary leukotriene E4
Abbreviations used : ATS, CBC, CT, EBC, ERS, FDA, Feno, 5-LO, HRCT, LTE4, NIH, NO
Plan
| 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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| Disclosure of potential conflict of interest: S. J. Szefler is a consultant for GlaxoSmithKline, Genentech, Merck, Boehringer-Ingelheim, Novartis, and Schering-Plough; and has received research support from the NIH (NHLBI, NIAID, NIEHS) and the Environmental Protection Agency. J. V. Fahy is on the Cytokinetics Scientific advisory board; has received consulting fees from Amgen, Gilcad, Five Prime Therapeutics, Merck, Regeneron Pharmaceuticals, Portola Pharmaceuticals; and has received research support from the NIH (NHLBI and NIAID) and Genentech. J. F. Hunt is on the Pulse Health LLC advisory board; is founder of Respiratory Research, Inc; has received research support from the NIH-NIAID and Altrea; and is Chair of the AAAAI Asthma Diagnosis and Pharmacotherapeutics Committee and Cough Committee. A. H. Liu has received speaker honoraria from Merck; is on the Data Safety Monitoring Board for GlaxoSmithKline; and is a consultant for DBV. R. A. Panettieri, Jr, is a consultant for Johnson & Johnson, Forest Pharmaceuticals, Genentech, and Merck; and has received research support from AstraZeneca, Johnson & Johnson, Merck, and Roche. R. P. Schleimer is a consultant for GlaxoSmithKline and Intersect ENT. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 129 - N° 3S
P. S9-S23 - mars 2012 Retour au numéro
Article précédent
- Asthma outcomes workshop: Overview
- William W. Busse, Wayne J. Morgan, Virginia Taggart, Alkis Togias
- Asthma outcomes: Composite scores of asthma control
- Michelle M. Cloutier, Michael Schatz, Mario Castro, Noreen Clark, H. William Kelly, Rita Mangione-Smith, James Sheller, Christine Sorkness, Stuart Stoloff, Peter Gergen
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