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Evaluation of the diagnostic accuracy of fractional exhaled nitric oxide (FeNO) in patients with suspected asthma: study protocol for a prospective diagnostic study

INTRODUCTION: The measurement of fractional exhaled nitric oxide (FeNO) is promising for diagnosing asthma and might substitute for bronchial provocation (BP) tests. To evaluate the diagnostic accuracy of FeNO within a confirmatory study, the following hypotheses will be tested: (1) A FeNO cut-off &...

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Autores principales: Kellerer, Christina, Hapfelmeier, Alexander, Jörres, Rudolf A, Schultz, Konrad, Brunn, Benjamin, Schneider, Antonius
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7883850/
https://www.ncbi.nlm.nih.gov/pubmed/33579773
http://dx.doi.org/10.1136/bmjopen-2020-045420
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author Kellerer, Christina
Hapfelmeier, Alexander
Jörres, Rudolf A
Schultz, Konrad
Brunn, Benjamin
Schneider, Antonius
author_facet Kellerer, Christina
Hapfelmeier, Alexander
Jörres, Rudolf A
Schultz, Konrad
Brunn, Benjamin
Schneider, Antonius
author_sort Kellerer, Christina
collection PubMed
description INTRODUCTION: The measurement of fractional exhaled nitric oxide (FeNO) is promising for diagnosing asthma and might substitute for bronchial provocation (BP) tests. To evaluate the diagnostic accuracy of FeNO within a confirmatory study, the following hypotheses will be tested: (1) A FeNO cut-off >50 ppb (parts per billion) is suitable for diagnosing asthma (sensitivity 35%, specificity 95%); (2) If the clinical symptoms ‘allergic rhinitis’ and ‘wheezing’ are present, asthma can be diagnosed at FeNO >33 ppb with a positive predictive value (PPV) >70% and (3) A FeNO >33 ppb can predict responsiveness to inhaled corticosteroid (ICS) with a PPV >70%. METHODS AND ANALYSIS: A prospective diagnostic study will be conducted in three practices of pneumologists in Germany. 300 patients suspected of suffering from asthma will be included. As an index test, patients perform FeNO measurement with the device NIOX VERO. As reference a test, patients are examined with whole bodyplethysmography and BP, if necessary. After 3 months, patients with an asthma diagnosis will be examined again to verify the diagnosis and evaluate ICS responsiveness. Patients who did not receive an asthma diagnosis at the initial examination will be phoned after 3 months and asked about persistent respiratory symptoms to exclude false negative findings. As a primary target, sensitivity and specificity of FeNO >50 ppb will be determined. As a secondary target the PPV for asthma at FeNO >33 ppb, when the symptoms ‘allergic rhinitis’ and ‘wheezing’ are present, will be calculated. Regarding ICS responsiveness, the PPV of FeNO >33 ppb will be determined. ETHICS AND DISSEMINATION: The study was approved by the Ethical Committee of the Technical University of Munich (Reference number 122/20 S). The major results will be published in peer-reviewed academic journals and disseminated through conferences. TRIAL REGISTRATION NUMBER: DRKS00021125.
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spelling pubmed-78838502021-02-25 Evaluation of the diagnostic accuracy of fractional exhaled nitric oxide (FeNO) in patients with suspected asthma: study protocol for a prospective diagnostic study Kellerer, Christina Hapfelmeier, Alexander Jörres, Rudolf A Schultz, Konrad Brunn, Benjamin Schneider, Antonius BMJ Open Respiratory Medicine INTRODUCTION: The measurement of fractional exhaled nitric oxide (FeNO) is promising for diagnosing asthma and might substitute for bronchial provocation (BP) tests. To evaluate the diagnostic accuracy of FeNO within a confirmatory study, the following hypotheses will be tested: (1) A FeNO cut-off >50 ppb (parts per billion) is suitable for diagnosing asthma (sensitivity 35%, specificity 95%); (2) If the clinical symptoms ‘allergic rhinitis’ and ‘wheezing’ are present, asthma can be diagnosed at FeNO >33 ppb with a positive predictive value (PPV) >70% and (3) A FeNO >33 ppb can predict responsiveness to inhaled corticosteroid (ICS) with a PPV >70%. METHODS AND ANALYSIS: A prospective diagnostic study will be conducted in three practices of pneumologists in Germany. 300 patients suspected of suffering from asthma will be included. As an index test, patients perform FeNO measurement with the device NIOX VERO. As reference a test, patients are examined with whole bodyplethysmography and BP, if necessary. After 3 months, patients with an asthma diagnosis will be examined again to verify the diagnosis and evaluate ICS responsiveness. Patients who did not receive an asthma diagnosis at the initial examination will be phoned after 3 months and asked about persistent respiratory symptoms to exclude false negative findings. As a primary target, sensitivity and specificity of FeNO >50 ppb will be determined. As a secondary target the PPV for asthma at FeNO >33 ppb, when the symptoms ‘allergic rhinitis’ and ‘wheezing’ are present, will be calculated. Regarding ICS responsiveness, the PPV of FeNO >33 ppb will be determined. ETHICS AND DISSEMINATION: The study was approved by the Ethical Committee of the Technical University of Munich (Reference number 122/20 S). The major results will be published in peer-reviewed academic journals and disseminated through conferences. TRIAL REGISTRATION NUMBER: DRKS00021125. BMJ Publishing Group 2021-02-12 /pmc/articles/PMC7883850/ /pubmed/33579773 http://dx.doi.org/10.1136/bmjopen-2020-045420 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Respiratory Medicine
Kellerer, Christina
Hapfelmeier, Alexander
Jörres, Rudolf A
Schultz, Konrad
Brunn, Benjamin
Schneider, Antonius
Evaluation of the diagnostic accuracy of fractional exhaled nitric oxide (FeNO) in patients with suspected asthma: study protocol for a prospective diagnostic study
title Evaluation of the diagnostic accuracy of fractional exhaled nitric oxide (FeNO) in patients with suspected asthma: study protocol for a prospective diagnostic study
title_full Evaluation of the diagnostic accuracy of fractional exhaled nitric oxide (FeNO) in patients with suspected asthma: study protocol for a prospective diagnostic study
title_fullStr Evaluation of the diagnostic accuracy of fractional exhaled nitric oxide (FeNO) in patients with suspected asthma: study protocol for a prospective diagnostic study
title_full_unstemmed Evaluation of the diagnostic accuracy of fractional exhaled nitric oxide (FeNO) in patients with suspected asthma: study protocol for a prospective diagnostic study
title_short Evaluation of the diagnostic accuracy of fractional exhaled nitric oxide (FeNO) in patients with suspected asthma: study protocol for a prospective diagnostic study
title_sort evaluation of the diagnostic accuracy of fractional exhaled nitric oxide (feno) in patients with suspected asthma: study protocol for a prospective diagnostic study
topic Respiratory Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7883850/
https://www.ncbi.nlm.nih.gov/pubmed/33579773
http://dx.doi.org/10.1136/bmjopen-2020-045420
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