Abstract
Background Studies of asthma and chronic obstructive pulmonary disease (COPD) typically focus on these diagnoses separately, limiting understanding of disease mechanisms and treatment options. NOVELTY is a global, 3-year, prospective observational study of patients with asthma and/or COPD from real-world clinical practice. We investigated heterogeneity and overlap by diagnosis and severity in this cohort.
Methods Patients with physician-assigned asthma, COPD or both (asthma+COPD) were enrolled, stratified by diagnosis and severity. Baseline characteristics were reported descriptively by physician-assigned diagnosis and/or severity. Factors associated with physician-assessed severity were evaluated using ordinal logistic regression analysis.
Results Of 11 243 patients, 5940 (52.8%) had physician-assigned asthma, 1396 (12.4%) had asthma+COPD and 3907 (34.8%) had COPD; almost half were from primary care. Symptoms, health-related quality of life and spirometry showed substantial heterogeneity and overlap between asthma, asthma+COPD and COPD, with 23%, 62% and 64% of patients, respectively, having post-bronchodilator FEV1/FVC <lower limit of normal.
Symptoms and exacerbations increased with greater physician-assessed severity, and were higher in asthma+COPD, but 24.3% with mild asthma and 20.4% with mild COPD had experienced ≥1 exacerbation in the past 12 months. Medication records suggested both under-treatment and over-treatment relative to severity. Blood eosinophil counts varied little across diagnosis/severity groups, but blood neutrophil counts increased with severity across all diagnoses.
Conclusion This analysis demonstrates marked heterogeneity within, and overlap between, physician-assigned diagnosis and severity groups in patients with asthma and/or COPD. Current diagnostic and severity classifications in clinical practice poorly differentiate between clinical phenotypes that may have specific risks and treatment implications.
Footnotes
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Conflict of interest: Dr. Lindner has nothing to disclose.
Conflict of interest: Dr. Reddel reports grants, personal fees and non-financial support from AstraZeneca, during the conduct of the study; grants and personal fees from AstraZeneca, grants and personal fees from GlaxoSmithKline, personal fees from Merck, personal fees from Novartis, personal fees from Teva, personal fees from Boehringer Ingelheim, personal fees from Sanofi Genzyme, personal fees from Chiesi, outside the submitted work; and Dr Reddel is Chair of the GINA Scientific Committee and a member of the GINA Board.
Conflict of interest: Dr. Vestbo reports personal fees from GlaxoSmithKline, during the conduct of the study; personal fees from GlaxoSmithKline, personal fees from Chiesi Pharmaceuticals, grants and personal fees from Boehringer-Ingelheim, personal fees from Novartis, personal fees from AstraZeneca, outside the submitted work.
Conflict of interest: Dr. Agusti reports personal fees from AstraZeneca, during the conduct of the study; grants and personal fees from GSK, grants and personal fees from Menarini, personal fees from Chiesi, outside the submitted work.
Conflict of interest: Dr. Anderson reports personal fees from Pieris Pharmaceuticals, personal fees from ENA Therapeutics, personal fees from ENA Respiratory , personal fees from AstraZeneca, personal fees from GSK, personal fees from AstraZeneca, personal fees from Menarini, personal fees from Novartis, outside the submitted work; In addition, Dr. Anderson has a patent US Patent 7,455,836 licensed to MorphoSys sublicenced to GSK.
Conflict of interest: Dr. Bansal has nothing to disclose.
Conflict of interest: Dr. Beasley reports personal fees from AstraZeneca, during the conduct of the study; grants and personal fees from AstraZeneca, grants from Genentech , grants and personal fees from GlaxoSmithKline, personal fees from Avillion, personal fees from Theravance, outside the submitted work; .
Conflict of interest: Dr. Bel reports grants and personal fees from AstraZeneca, GSK, Novartis, and Teva, and personal fees from Sanofi/Regeneron, Sterna, and Chiesi, outside the submitted work.
Conflict of interest: Dr. Janson reports personal fees from AstraZeneca, personal fees from Boehringer Ingelheim, personal fees from Chiesi, personal fees from GlaxoSmithKline, personal fees from Novartis, personal fees from TEVA, outside the submitted work.
Conflict of interest: Dr. Make reports grants, non-financial support and other from Astra Zeneca, non-financial support from Spiration, grants, non-financial support and other from Glaxo Smith Kline, grants, non-financial support and other from Sunovion, other from Mt. Sinai, other from Web MD, other from National Jewish Health, other from Novartis, other from American College of Chest Physicians, other from Projects in Knowledge, other from Hybrid Communications, grants from Pearl Research, other from Medscape, other from Verona, other from Boehringer Ingelheim, other from Theravance, other from Ultimate Medical Academy, non-financial support and other from Circassia, personal fees and non-financial support from Third Pole, non-financial support and other from Shire, non-financial support and other from Phillips, other from Eastern Pulmonary Society, other from Catamount Medical, other from Science 24/7, other from Eastern VA Medical Center, other from Academy Continued Health Care Learning, grants from NHLBI, personal fees from Takeda, other from Wolters Kluwer Health, outside the submitted work.
Conflict of interest: Dr. Pavord reports personal fees from AstraZeneca, personal fees from Boehringer Ingelheim, personal fees from Aerocrine, personal fees from Almirall, personal fees from Novartis, personal fees from GlaxoSmithKline, personal fees from Genentech, personal fees from Regeneron, from Teva, from Chiesi, from Sanofi, from Circassia, from Knopp, grants from NIHR, outside the submitted work.
Conflict of interest: Dr. Price reports other from AstraZeneca, during the conduct of the study; personal fees from Amgen, grants and personal fees from AstraZeneca, grants and personal fees from Boehringer Ingelheim, grants and personal fees from Chiesi, grants and personal fees from Circassia, personal fees from Cipla, personal fees from GlaxoSmithKline, personal fees from Kyorin, grants and personal fees from Mylan, grants and personal fees from Mundipharma, grants and personal fees from Novartis, grants and personal fees from Pfizer, grants and personal fees from Regeneron Pharmaceuticals, grants from Respiratory Effectiveness Group, grants and personal fees from Sanofi Genzyme, grants and personal fees from Teva, grants and personal fees from Theravance, personal fees from Thermofisher, grants from UK National Health Service, non-financial support from Efficacy and Evaluation Mechanism Programme, non-financial support from Health Technology Assessment, outside the submitted work; and stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; and owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore).
Conflict of interest: Dr. Rapsomaniki reports working for AstraZeneca (UK).
Conflict of interest: Dr. Karlsson reports personal fees from AstraZeneca, outside the submitted work.
Conflict of interest: Dr. Finch reports AZ employee at time of authorship.
Conflict of interest: Mr. Nuevo reports he is an AstraZeneca employee.
Conflict of interest: Dr. de Giorgio-Miller has nothing to disclose.
Conflict of interest: Dr. Alacqua has nothing to disclose.
Conflict of interest: Dr. Hughes reports personal fees from GlaxoSmithKline, personal fees from Novartis, personal fees from Boehringer Ingelheim, personal fees from AstraZeneca, outside the submitted work; and Employee of AstraZeneca.
Conflict of interest: Dr. Müllerová reports and an employee of AZ.
Conflict of interest: Dr. Gerhardsson de Verdier reports personal fees from AstraZeneca, outside the submitted work.
Conflict of interest: Dr. Agusti reports personal fees from AstraZeneca, during the conduct of the study; grants and personal fees from GSK, grants and personal fees from Menarini, personal fees from Chiesi, outside the submitted work.
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- Received October 27, 2020.
- Accepted February 8, 2021.
- Copyright ©The authors 2021. For reproduction rights and permissions contact permissions{at}ersnet.org
