Prospective observational study in patients with obstructive lung disease: NOVELTY design

Overig (Observational research)

Lindy van Burk
AstraZeneca, Medical Affairs Respiratory
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.

Acknowledgement:
This abstract has been previously published in an online publication by the European Respiratory Society (ERS). This material has not been reviewed prior to release by the ERS; therefore the ERS may not be responsible for any errors, omissions or inaccuracies, or for any consequences arising there from, in the content. Reproduced with permission of the © ERS 2019.
ERJ Open Res 5: 00036-2018; DOI: 10.1183/23120541.00036-2018 Published 1 February 2019

Full list of authors:
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, Frederik Nyberg, Simon S Young, Jørgen Vestbo, and Maarten van den Berge.
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