RT Journal Article
SR Electronic
T1 Prospective observational study in patients with obstructive lung disease: NOVELTY design
JF ERJ Open Research
JO erjor
FD European Respiratory Society
SP 00036-2018
DO 10.1183/23120541.00036-2018
VO 5
IS 1
A1 Reddel, Helen K.
A1 Gerhardsson de Verdier, Maria
A1 Agustí, Alvar
A1 Anderson, Gary
A1 Beasley, Richard
A1 Bel, Elisabeth H.
A1 Janson, Christer
A1 Make, Barry
A1 Martin, Richard J.
A1 Pavord, Ian
A1 Price, David
A1 Keen, Christina
A1 Gardev, Asparuh
A1 Rennard, Stephen
A1 Sveréus, Alecka
A1 Bansal, Aruna T.
A1 Brannman, Lance
A1 Karlsson, Niklas
A1 Nuevo, Javier
A1 Nyberg, Fredrik
A1 Young, Simon S.
A1 Vestbo, Jørgen
YR 2019
UL http://openres.ersjournals.com/content/5/1/00036-2018.abstract
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.NOVELTY is a global study to characterise patients with asthma and/or COPD and identify novel phenotypes and endotypes http://ow.ly/QFiH30n3IBF