Prospective observational study in patients with obstructive lung disease

NOVELTY design

Helen K Reddel, Maria Gerhardsson de Verdier, Alvar Agustí, Gary Anderson, Richard Beasley, Elisabeth H Bel, Christer Janson, Barry Make, Richard J Martin, Ian Pavord, David Price, Christina Keen, Asparuh Gardev, Stephen Rennard, Alecka Sveréus, Aruna T Bansal, Lance Brannman, Niklas Karlsson, Javier Nuevo, Fredrik Nyberg & 2 others Simon S Young, Jørgen Vestbo

Research output: Contribution to journalArticle

3 Downloads (Pure)

Abstract

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.

Original languageEnglish
Article number00036-2018
JournalERJ Open Research
Volume5
Issue number1
Early online date1 Feb 2019
DOIs
Publication statusPublished - Feb 2019

Fingerprint

Obstructive Lung Diseases
Observational Studies
Prospective Studies
Chronic Obstructive Pulmonary Disease
Asthma
Delivery of Health Care
Phenotype
Information Storage and Retrieval
Spirometry
Telephone
Internet
Biomarkers
Pharmaceutical Preparations

Cite this

Reddel, H. K., Gerhardsson de Verdier, M., Agustí, A., Anderson, G., Beasley, R., Bel, E. H., ... Vestbo, J. (2019). Prospective observational study in patients with obstructive lung disease: NOVELTY design. ERJ Open Research, 5(1), [00036-2018]. https://doi.org/10.1183/23120541.00036-2018

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.

In: ERJ Open Research, Vol. 5, No. 1, 00036-2018, 02.2019.

Research output: Contribution to journalArticle

Reddel, HK, Gerhardsson de Verdier, M, Agustí, A, Anderson, G, Beasley, R, Bel, EH, Janson, C, Make, B, Martin, RJ, Pavord, I, Price, D, Keen, C, Gardev, A, Rennard, S, Sveréus, A, Bansal, AT, Brannman, L, Karlsson, N, Nuevo, J, Nyberg, F, Young, SS & Vestbo, J 2019, 'Prospective observational study in patients with obstructive lung disease: NOVELTY design', ERJ Open Research, vol. 5, no. 1, 00036-2018. https://doi.org/10.1183/23120541.00036-2018
Reddel HK, Gerhardsson de Verdier M, Agustí A, Anderson G, Beasley R, Bel EH et al. Prospective observational study in patients with obstructive lung disease: NOVELTY design. ERJ Open Research. 2019 Feb;5(1). 00036-2018. https://doi.org/10.1183/23120541.00036-2018
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. In: ERJ Open Research. 2019 ; Vol. 5, No. 1.
@article{d0e2cf27b035470d807480e9cef513fd,
title = "Prospective observational study in patients with obstructive lung disease: NOVELTY design",
abstract = "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.",
author = "Reddel, {Helen K} and {Gerhardsson de Verdier}, Maria and Alvar Agust{\'i} and Gary Anderson and Richard Beasley and Bel, {Elisabeth H} and Christer Janson and Barry Make and Martin, {Richard J} and Ian Pavord and David Price and Christina Keen and Asparuh Gardev and Stephen Rennard and Alecka Sver{\'e}us and Bansal, {Aruna T} and Lance Brannman and Niklas Karlsson and Javier Nuevo and Fredrik Nyberg and Young, {Simon S} and J{\o}rgen Vestbo",
year = "2019",
month = "2",
doi = "10.1183/23120541.00036-2018",
language = "English",
volume = "5",
journal = "ERJ Open Research",
issn = "2312-0541",
publisher = "European Respiratory Society",
number = "1",

}

TY - JOUR

T1 - Prospective observational study in patients with obstructive lung disease

T2 - NOVELTY design

AU - Reddel, Helen K

AU - Gerhardsson de Verdier, Maria

AU - Agustí, Alvar

AU - Anderson, Gary

AU - Beasley, Richard

AU - Bel, Elisabeth H

AU - Janson, Christer

AU - Make, Barry

AU - Martin, Richard J

AU - Pavord, Ian

AU - Price, David

AU - Keen, Christina

AU - Gardev, Asparuh

AU - Rennard, Stephen

AU - Sveréus, Alecka

AU - Bansal, Aruna T

AU - Brannman, Lance

AU - Karlsson, Niklas

AU - Nuevo, Javier

AU - Nyberg, Fredrik

AU - Young, Simon S

AU - Vestbo, Jørgen

PY - 2019/2

Y1 - 2019/2

N2 - 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.

AB - 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.

UR - http://www.mendeley.com/research/prospective-observational-study-patients-obstructive-lung-disease-novelty-design

U2 - 10.1183/23120541.00036-2018

DO - 10.1183/23120541.00036-2018

M3 - Article

VL - 5

JO - ERJ Open Research

JF - ERJ Open Research

SN - 2312-0541

IS - 1

M1 - 00036-2018

ER -