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Prospective observational study in patients with obstructive lung disease: NOVELTY design
Asthma and chronic obstructive pulmonary disease (COPD) have overlapping clinical features and share pathobiological mechanisms but are often considered distinct disorders. Prospective, observational studies across asthma, COPD and asthma–COPD overlap are limited. NOVELTY is a global, prospective ob...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
European Respiratory Society
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6355976/ https://www.ncbi.nlm.nih.gov/pubmed/30723727 http://dx.doi.org/10.1183/23120541.00036-2018 |
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author | Reddel, Helen K. Gerhardsson de Verdier, Maria Agustí, Alvar Anderson, Gary Beasley, Richard Bel, Elisabeth H. Janson, Christer Make, Barry Martin, Richard J. Pavord, Ian Price, David Keen, Christina Gardev, Asparuh Rennard, Stephen Sveréus, Alecka Bansal, Aruna T. Brannman, Lance Karlsson, Niklas Nuevo, Javier Nyberg, Fredrik Young, Simon S. Vestbo, Jørgen |
author_facet | Reddel, Helen K. Gerhardsson de Verdier, Maria Agustí, Alvar Anderson, Gary Beasley, Richard Bel, Elisabeth H. Janson, Christer Make, Barry Martin, Richard J. Pavord, Ian Price, David Keen, Christina Gardev, Asparuh Rennard, Stephen Sveréus, Alecka Bansal, Aruna T. Brannman, Lance Karlsson, Niklas Nuevo, Javier Nyberg, Fredrik Young, Simon S. Vestbo, Jørgen |
author_sort | Reddel, Helen K. |
collection | PubMed |
description | Asthma and chronic obstructive pulmonary disease (COPD) have overlapping clinical features and share pathobiological mechanisms but are often considered distinct disorders. Prospective, observational studies across asthma, COPD and asthma–COPD overlap are limited. NOVELTY is a global, prospective observational 3-year study enrolling ∼12 000 patients ≥12 years of age from primary and specialist clinical practices in 19 countries (ClinicalTrials.gov identifier: NCT02760329). NOVELTY's primary objectives are to describe patient characteristics, treatment patterns and disease burden over time, and to identify phenotypes and molecular endotypes associated with differential outcomes over time in patients with a diagnosis/suspected diagnosis of asthma and/or COPD. NOVELTY aims to recruit real-world patients, unlike clinical studies with restrictive inclusion/exclusion criteria. Data collected at yearly intervals include clinical assessments, spirometry, biospecimens, patient-reported outcomes (PROs) and healthcare utilisation (HCU). PROs and HCU will also be collected 3-monthly via internet/telephone. Data will be used to identify phenotypes and endotypes associated with different trajectories for symptom burden, clinical progression or remission and HCU. Results may allow patient classification across obstructive lung disease by clinical outcomes and biomarker profile, rather than by conventional diagnostic labels and severity categories. NOVELTY will provide a rich data source on obstructive lung disease, to help improve patient outcomes and aid novel drug development. |
format | Online Article Text |
id | pubmed-6355976 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | European Respiratory Society |
record_format | MEDLINE/PubMed |
spelling | pubmed-63559762019-02-05 Prospective observational study in patients with obstructive lung disease: NOVELTY design Reddel, Helen K. Gerhardsson de Verdier, Maria Agustí, Alvar Anderson, Gary Beasley, Richard Bel, Elisabeth H. Janson, Christer Make, Barry Martin, Richard J. Pavord, Ian Price, David Keen, Christina Gardev, Asparuh Rennard, Stephen Sveréus, Alecka Bansal, Aruna T. Brannman, Lance Karlsson, Niklas Nuevo, Javier Nyberg, Fredrik Young, Simon S. Vestbo, Jørgen ERJ Open Res Study Protocol Asthma and chronic obstructive pulmonary disease (COPD) have overlapping clinical features and share pathobiological mechanisms but are often considered distinct disorders. Prospective, observational studies across asthma, COPD and asthma–COPD overlap are limited. NOVELTY is a global, prospective observational 3-year study enrolling ∼12 000 patients ≥12 years of age from primary and specialist clinical practices in 19 countries (ClinicalTrials.gov identifier: NCT02760329). NOVELTY's primary objectives are to describe patient characteristics, treatment patterns and disease burden over time, and to identify phenotypes and molecular endotypes associated with differential outcomes over time in patients with a diagnosis/suspected diagnosis of asthma and/or COPD. NOVELTY aims to recruit real-world patients, unlike clinical studies with restrictive inclusion/exclusion criteria. Data collected at yearly intervals include clinical assessments, spirometry, biospecimens, patient-reported outcomes (PROs) and healthcare utilisation (HCU). PROs and HCU will also be collected 3-monthly via internet/telephone. Data will be used to identify phenotypes and endotypes associated with different trajectories for symptom burden, clinical progression or remission and HCU. Results may allow patient classification across obstructive lung disease by clinical outcomes and biomarker profile, rather than by conventional diagnostic labels and severity categories. NOVELTY will provide a rich data source on obstructive lung disease, to help improve patient outcomes and aid novel drug development. European Respiratory Society 2019-02-01 /pmc/articles/PMC6355976/ /pubmed/30723727 http://dx.doi.org/10.1183/23120541.00036-2018 Text en Copyright ©ERS 2019 http://creativecommons.org/licenses/by-nc/4.0/ This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. |
spellingShingle | Study Protocol Reddel, Helen K. Gerhardsson de Verdier, Maria Agustí, Alvar Anderson, Gary Beasley, Richard Bel, Elisabeth H. Janson, Christer Make, Barry Martin, Richard J. Pavord, Ian Price, David Keen, Christina Gardev, Asparuh Rennard, Stephen Sveréus, Alecka Bansal, Aruna T. Brannman, Lance Karlsson, Niklas Nuevo, Javier Nyberg, Fredrik Young, Simon S. Vestbo, Jørgen Prospective observational study in patients with obstructive lung disease: NOVELTY design |
title | Prospective observational study in patients with obstructive lung disease: NOVELTY design |
title_full | Prospective observational study in patients with obstructive lung disease: NOVELTY design |
title_fullStr | Prospective observational study in patients with obstructive lung disease: NOVELTY design |
title_full_unstemmed | Prospective observational study in patients with obstructive lung disease: NOVELTY design |
title_short | Prospective observational study in patients with obstructive lung disease: NOVELTY design |
title_sort | prospective observational study in patients with obstructive lung disease: novelty design |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6355976/ https://www.ncbi.nlm.nih.gov/pubmed/30723727 http://dx.doi.org/10.1183/23120541.00036-2018 |
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