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 11243 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
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