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FOOTPRINTS study protocol: rationale and methodology of a 3-year longitudinal observational study to phenotype patients with COPD
INTRODUCTION: A better understanding is needed of the different phenotypes that exist for patients with chronic obstructive pulmonary disease (COPD), their relationship with the pathogenesis of COPD and how they may affect disease progression. Biomarkers, including those associated with emphysema, m...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7986686/ https://www.ncbi.nlm.nih.gov/pubmed/33753437 http://dx.doi.org/10.1136/bmjopen-2020-042526 |
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author | Crapo, James Gupta, Abhya Lynch, David A Vogel-Claussen, Jens Watz, Henrik Turner, Alice M Mroz, Robert M Janssens, Wim Ludwig-Sengpiel, Andrea Beck, Markus Langellier, Bérengère Ittrich, Carina Risse, Frank Diefenbach, Claudia |
author_facet | Crapo, James Gupta, Abhya Lynch, David A Vogel-Claussen, Jens Watz, Henrik Turner, Alice M Mroz, Robert M Janssens, Wim Ludwig-Sengpiel, Andrea Beck, Markus Langellier, Bérengère Ittrich, Carina Risse, Frank Diefenbach, Claudia |
author_sort | Crapo, James |
collection | PubMed |
description | INTRODUCTION: A better understanding is needed of the different phenotypes that exist for patients with chronic obstructive pulmonary disease (COPD), their relationship with the pathogenesis of COPD and how they may affect disease progression. Biomarkers, including those associated with emphysema, may assist in characterising patients and in predicting and monitoring the course of disease. The FOOTPRINTS study (study 352.2069) aims to identify biomarkers associated with emphysema, over a 3-year period. METHODS AND ANALYSIS: The FOOTPRINTS study is a prospective, longitudinal, multinational (12 countries), multicentre (51 sites) biomarker study, which has enrolled a total of 463 ex-smokers, including subjects without airflow limitation (as defined by the 2015 Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy report), patients with COPD across the GOLD stages 1–3 and patients with COPD and alpha1-antitrypsin deficiency. The study has an observational period lasting 156 weeks that includes seven site visits and additional phone interviews. Biomarkers in blood and sputum, imaging data (CT and magnetic resonance), clinical parameters, medical events of special interest and safety are being assessed at regular visits. Disease progression based on biomarker values and COPD phenotypes are being assessed using multivariate statistical prediction models. ETHICS AND DISSEMINATION: The study protocol was approved by the authorities and ethics committees/institutional review boards of the respective institutions where applicable, which included study sites in Belgium, Canada, Denmark, Finland, Germany, Japan, Korea, Poland, Spain, Sweden, UK and USA; written informed consent has been obtained from all study participants. Ethics committee approval was obtained for all participating sites prior to enrolment of the study participants. The study results will be reported in peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT02719184. |
format | Online Article Text |
id | pubmed-7986686 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-79866862021-03-29 FOOTPRINTS study protocol: rationale and methodology of a 3-year longitudinal observational study to phenotype patients with COPD Crapo, James Gupta, Abhya Lynch, David A Vogel-Claussen, Jens Watz, Henrik Turner, Alice M Mroz, Robert M Janssens, Wim Ludwig-Sengpiel, Andrea Beck, Markus Langellier, Bérengère Ittrich, Carina Risse, Frank Diefenbach, Claudia BMJ Open Respiratory Medicine INTRODUCTION: A better understanding is needed of the different phenotypes that exist for patients with chronic obstructive pulmonary disease (COPD), their relationship with the pathogenesis of COPD and how they may affect disease progression. Biomarkers, including those associated with emphysema, may assist in characterising patients and in predicting and monitoring the course of disease. The FOOTPRINTS study (study 352.2069) aims to identify biomarkers associated with emphysema, over a 3-year period. METHODS AND ANALYSIS: The FOOTPRINTS study is a prospective, longitudinal, multinational (12 countries), multicentre (51 sites) biomarker study, which has enrolled a total of 463 ex-smokers, including subjects without airflow limitation (as defined by the 2015 Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy report), patients with COPD across the GOLD stages 1–3 and patients with COPD and alpha1-antitrypsin deficiency. The study has an observational period lasting 156 weeks that includes seven site visits and additional phone interviews. Biomarkers in blood and sputum, imaging data (CT and magnetic resonance), clinical parameters, medical events of special interest and safety are being assessed at regular visits. Disease progression based on biomarker values and COPD phenotypes are being assessed using multivariate statistical prediction models. ETHICS AND DISSEMINATION: The study protocol was approved by the authorities and ethics committees/institutional review boards of the respective institutions where applicable, which included study sites in Belgium, Canada, Denmark, Finland, Germany, Japan, Korea, Poland, Spain, Sweden, UK and USA; written informed consent has been obtained from all study participants. Ethics committee approval was obtained for all participating sites prior to enrolment of the study participants. The study results will be reported in peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT02719184. BMJ Publishing Group 2021-03-22 /pmc/articles/PMC7986686/ /pubmed/33753437 http://dx.doi.org/10.1136/bmjopen-2020-042526 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 Crapo, James Gupta, Abhya Lynch, David A Vogel-Claussen, Jens Watz, Henrik Turner, Alice M Mroz, Robert M Janssens, Wim Ludwig-Sengpiel, Andrea Beck, Markus Langellier, Bérengère Ittrich, Carina Risse, Frank Diefenbach, Claudia FOOTPRINTS study protocol: rationale and methodology of a 3-year longitudinal observational study to phenotype patients with COPD |
title | FOOTPRINTS study protocol: rationale and methodology of a 3-year longitudinal observational study to phenotype patients with COPD |
title_full | FOOTPRINTS study protocol: rationale and methodology of a 3-year longitudinal observational study to phenotype patients with COPD |
title_fullStr | FOOTPRINTS study protocol: rationale and methodology of a 3-year longitudinal observational study to phenotype patients with COPD |
title_full_unstemmed | FOOTPRINTS study protocol: rationale and methodology of a 3-year longitudinal observational study to phenotype patients with COPD |
title_short | FOOTPRINTS study protocol: rationale and methodology of a 3-year longitudinal observational study to phenotype patients with COPD |
title_sort | footprints study protocol: rationale and methodology of a 3-year longitudinal observational study to phenotype patients with copd |
topic | Respiratory Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7986686/ https://www.ncbi.nlm.nih.gov/pubmed/33753437 http://dx.doi.org/10.1136/bmjopen-2020-042526 |
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