The use of the mannitol test as an outcome measure in asthma intervention studies: a review and practical recommendations

Abstract Background The mannitol test is an indirect bronchial challenge test widely used in diagnosing asthma. Response to the mannitol test correlates with the level of eosinophilic and mast cell airway inflammation, and a positive mannitol test is highly predictive of a response to anti-inflammat...

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Autores principales:	Asger Sverrild, Joanna Leadbetter, Celeste Porsbjerg
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Airway hyperresponsiveness Asthma Bronchoprovocation Outcome measure Intervention studies PD15 Diseases of the respiratory system RC705-779
Acceso en línea:	https://doaj.org/article/9af252c96bf9428eb3535179a6895efe
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spelling	oai:doaj.org-article:9af252c96bf9428eb3535179a6895efe2021-11-14T12:31:53ZThe use of the mannitol test as an outcome measure in asthma intervention studies: a review and practical recommendations10.1186/s12931-021-01876-91465-993Xhttps://doaj.org/article/9af252c96bf9428eb3535179a6895efe2021-11-01T00:00:00Zhttps://doi.org/10.1186/s12931-021-01876-9https://doaj.org/toc/1465-993XAbstract Background The mannitol test is an indirect bronchial challenge test widely used in diagnosing asthma. Response to the mannitol test correlates with the level of eosinophilic and mast cell airway inflammation, and a positive mannitol test is highly predictive of a response to anti-inflammatory treatment with inhaled corticosteroids. The response to mannitol is a physiological biomarker that may, therefore, be used to assess the response to other anti-inflammatory treatments and may be of particular interest in early phase studies that require surrogate markers to predict a clinical response. The main objectives of this review were to assess the practical aspects of using mannitol as an endpoint in clinical trials and provide the clinical researcher and respiratory physician with recommendations when designing early clinical trials. Methods The aim of this review was to summarise previous uses of the mannitol test as an outcome measure in clinical intervention studies. The PubMed database was searched using a combination of MeSH and keywords. Eligible studies included intervention or repeatability studies using the standard mannitol test, at multiple timepoints, reporting the use of PD15 as a measure, and published in English. Results Of the 193 papers identified, 12 studies met the inclusion criteria and data from these are discussed in detail. Data on the mode of action, correlation with airway inflammation, its diagnostic properties, and repeatability have been summarised, and suggestions for the reporting of test results provided. Worked examples of power calculations for dimensioning study populations are presented for different types of study designs. Finally, interpretation and reporting of the change in the response to the mannitol test are discussed. Conclusions The mechanistic and practical features of the mannitol test make it a useful marker of disease, not only in clinical diagnoses, but also as an outcome measure in intervention trials. Measuring airway hyperresponsiveness to mannitol provides a novel and reproducible test for assessing efficacy in intervention trials, and importantly, utilises a test that links directly to underlying drivers of disease.Asger SverrildJoanna LeadbetterCeleste PorsbjergBMCarticleAirway hyperresponsivenessAsthmaBronchoprovocationOutcome measureIntervention studiesPD15Diseases of the respiratory systemRC705-779ENRespiratory Research, Vol 22, Iss 1, Pp 1-12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Airway hyperresponsiveness Asthma Bronchoprovocation Outcome measure Intervention studies PD15 Diseases of the respiratory system RC705-779
spellingShingle	Airway hyperresponsiveness Asthma Bronchoprovocation Outcome measure Intervention studies PD15 Diseases of the respiratory system RC705-779 Asger Sverrild Joanna Leadbetter Celeste Porsbjerg The use of the mannitol test as an outcome measure in asthma intervention studies: a review and practical recommendations
description	Abstract Background The mannitol test is an indirect bronchial challenge test widely used in diagnosing asthma. Response to the mannitol test correlates with the level of eosinophilic and mast cell airway inflammation, and a positive mannitol test is highly predictive of a response to anti-inflammatory treatment with inhaled corticosteroids. The response to mannitol is a physiological biomarker that may, therefore, be used to assess the response to other anti-inflammatory treatments and may be of particular interest in early phase studies that require surrogate markers to predict a clinical response. The main objectives of this review were to assess the practical aspects of using mannitol as an endpoint in clinical trials and provide the clinical researcher and respiratory physician with recommendations when designing early clinical trials. Methods The aim of this review was to summarise previous uses of the mannitol test as an outcome measure in clinical intervention studies. The PubMed database was searched using a combination of MeSH and keywords. Eligible studies included intervention or repeatability studies using the standard mannitol test, at multiple timepoints, reporting the use of PD15 as a measure, and published in English. Results Of the 193 papers identified, 12 studies met the inclusion criteria and data from these are discussed in detail. Data on the mode of action, correlation with airway inflammation, its diagnostic properties, and repeatability have been summarised, and suggestions for the reporting of test results provided. Worked examples of power calculations for dimensioning study populations are presented for different types of study designs. Finally, interpretation and reporting of the change in the response to the mannitol test are discussed. Conclusions The mechanistic and practical features of the mannitol test make it a useful marker of disease, not only in clinical diagnoses, but also as an outcome measure in intervention trials. Measuring airway hyperresponsiveness to mannitol provides a novel and reproducible test for assessing efficacy in intervention trials, and importantly, utilises a test that links directly to underlying drivers of disease.
format	article
author	Asger Sverrild Joanna Leadbetter Celeste Porsbjerg
author_facet	Asger Sverrild Joanna Leadbetter Celeste Porsbjerg
author_sort	Asger Sverrild
title	The use of the mannitol test as an outcome measure in asthma intervention studies: a review and practical recommendations
title_short	The use of the mannitol test as an outcome measure in asthma intervention studies: a review and practical recommendations
title_full	The use of the mannitol test as an outcome measure in asthma intervention studies: a review and practical recommendations
title_fullStr	The use of the mannitol test as an outcome measure in asthma intervention studies: a review and practical recommendations
title_full_unstemmed	The use of the mannitol test as an outcome measure in asthma intervention studies: a review and practical recommendations
title_sort	use of the mannitol test as an outcome measure in asthma intervention studies: a review and practical recommendations
publisher	BMC
publishDate	2021
url	https://doaj.org/article/9af252c96bf9428eb3535179a6895efe
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The use of the mannitol test as an outcome measure in asthma intervention studies: a review and practical recommendations

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