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...

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Main Authors: Reddel, H, Gerhardsson de Verdier, M, Agustí, A, Anderson, G, Beasley, R, Bel, E, Janson, C, Make, B, Martin, R, Pavord, I, Price, D, Keen, C, Gardev, A, Rennard, S, Sveréus, A, Bansal, A, Brannman, L, Karlsson, N, Nuevo, J, Nyberg, F, Young, S, Vestbo, J
Format: Journal article
Language:English
Published: European Respiratory Society 2019
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author Reddel, H
Gerhardsson de Verdier, M
Agustí, A
Anderson, G
Beasley, R
Bel, E
Janson, C
Make, B
Martin, R
Pavord, I
Price, D
Keen, C
Gardev, A
Rennard, S
Sveréus, A
Bansal, A
Brannman, L
Karlsson, N
Nuevo, J
Nyberg, F
Young, S
Vestbo, J
author_facet Reddel, H
Gerhardsson de Verdier, M
Agustí, A
Anderson, G
Beasley, R
Bel, E
Janson, C
Make, B
Martin, R
Pavord, I
Price, D
Keen, C
Gardev, A
Rennard, S
Sveréus, A
Bansal, A
Brannman, L
Karlsson, N
Nuevo, J
Nyberg, F
Young, S
Vestbo, J
author_sort Reddel, H
collection OXFORD
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.
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spelling oxford-uuid:4a785ccd-fae5-4779-a7f8-fe52e9d4112a2022-03-26T15:37:40ZProspective observational study in patients with obstructive lung disease: NOVELTY designJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:4a785ccd-fae5-4779-a7f8-fe52e9d4112aEnglishSymplectic Elements at OxfordEuropean Respiratory Society2019Reddel, HGerhardsson de Verdier, MAgustí, AAnderson, GBeasley, RBel, EJanson, CMake, BMartin, RPavord, IPrice, DKeen, CGardev, ARennard, SSveréus, ABansal, ABrannman, LKarlsson, NNuevo, JNyberg, FYoung, SVestbo, JAsthma 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.
spellingShingle Reddel, H
Gerhardsson de Verdier, M
Agustí, A
Anderson, G
Beasley, R
Bel, E
Janson, C
Make, B
Martin, R
Pavord, I
Price, D
Keen, C
Gardev, A
Rennard, S
Sveréus, A
Bansal, A
Brannman, L
Karlsson, N
Nuevo, J
Nyberg, F
Young, S
Vestbo, J
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
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