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...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
European Respiratory Society
2019-02-01
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| Series: | ERJ Open Research |
| Online Access: | http://openres.ersjournals.com/content/5/1/00036-2018.full |
| _version_ | 1818729271788568576 |
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| author | 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 Simon S. Young Jørgen Vestbo |
| author_facet | 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 Simon S. Young Jørgen Vestbo |
| author_sort | Helen K. Reddel |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-12-17T22:43:14Z |
| format | Article |
| id | doaj.art-94344c7fc4684db09a24b7b6c4cf5c7a |
| institution | Directory Open Access Journal |
| issn | 2312-0541 |
| language | English |
| last_indexed | 2024-12-17T22:43:14Z |
| publishDate | 2019-02-01 |
| publisher | European Respiratory Society |
| record_format | Article |
| series | ERJ Open Research |
| spelling | doaj.art-94344c7fc4684db09a24b7b6c4cf5c7a2022-12-21T21:29:53ZengEuropean Respiratory SocietyERJ Open Research2312-05412019-02-015110.1183/23120541.00036-201800036-2018Prospective observational study in patients with obstructive lung disease: NOVELTY designHelen K. Reddel0Maria Gerhardsson de Verdier1Alvar Agustí2Gary Anderson3Richard Beasley4Elisabeth H. Bel5Christer Janson6Barry Make7Richard J. Martin8Ian Pavord9David Price10Christina Keen11Asparuh Gardev12Stephen Rennard13Alecka Sveréus14Aruna T. Bansal15Lance Brannman16Niklas Karlsson17Javier Nuevo18Fredrik Nyberg19Simon S. Young20Jørgen Vestbo21 Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia Respiratory TA, Global Medical Affairs, AstraZeneca, Mölndal, Sweden Respiratory Institute, Hospital Clinic, University of Barcelona, IDIBAPS, CIBERES, Barcelona, Spain Lung Health Research Centre, University of Melbourne, Melbourne, Australia Medical Research Institute of New Zealand, Wellington, New Zealand Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands Dept of Medical Sciences, Uppsala University, Uppsala, Sweden National Jewish Health and University of Colorado Denver, Denver, CO, USA National Jewish Health and University of Colorado Denver, Denver, CO, USA Nuffield Dept of Medicine, University of Oxford, Oxford, UK Observational and Pragmatic Research Institute, Singapore and Centre of Academic Primary Care, University of Aberdeen, Aberdeen, UK Early Clinical Development IMED Biotech Unit, AstraZeneca, Mölndal, Sweden Global Medical Affairs, AstraZeneca, Cambridge, UK Early Clinical Development, IMED Biotech Unit, AstraZeneca, Cambridge, UK Respiratory TA, Global Medical Affairs, AstraZeneca, Mölndal, Sweden Acclarogen Ltd, Cambridge, UK US Medical Affairs, AstraZeneca, Gaithersberg, MD, USA Patient Reported Outcomes, Medical Evidence and Observational Research, Global Medical Affairs, AstraZeneca, Mölndal, Sweden Respiratory TA, Global Medical Affairs, AstraZeneca, Madrid, Spain Medical Evidence and Observational Research, Global Medical Affairs, AstraZeneca, Mölndal, Sweden Precision Medicine and Genomics, IMED Biotech Unit, AstraZeneca, Cambridge, UK School of Biological Sciences, University of Manchester, Manchester, UK 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.http://openres.ersjournals.com/content/5/1/00036-2018.full |
| spellingShingle | 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 Simon S. Young Jørgen Vestbo Prospective observational study in patients with obstructive lung disease: NOVELTY design ERJ Open Research |
| 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 |
| url | http://openres.ersjournals.com/content/5/1/00036-2018.full |
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