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.

Patients with physician-assigned asthma, COPD or both (asthma+COPD) were enrolled, and 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.

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 a ratio of post-bronchodilator forced expiratory volume in 1 s to forced vital capacity below the lower limit of normal. Symptoms and exacerbations increased with greater physician-assessed severity and were higher in asthma+COPD. However, 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 and severity groups, but blood neutrophil counts increased with severity across all diagnoses.

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.

对哮喘和慢性阻塞性肺病 (COPD) 的研究通常分别关注这些诊断，限制了对疾病机制和治疗方案的了解。NOVELTY 是一项针对真实临床实践的哮喘和/或慢性阻塞性肺病患者进行的为期 3 年的全球前瞻性观察研究。我们调查了该队列中诊断和严重程度的异质性和重叠性。

患有医生指定的哮喘、慢性阻塞性肺病或两者（哮喘+慢性阻塞性肺病）的患者被纳入，并根据诊断和严重程度进行分层。根据医生指定的诊断和/或严重程度描述性地报告基线特征。使用序数逻辑回归分析评估与医生评估的严重程度相关的因素。

在 11 243 名患者中，5940 名（52.8%）患有医生指定的哮喘，1396 名（12.4%）患有哮喘+慢性阻塞性肺病，3907 名（34.8%）患有慢性阻塞性肺病；几乎一半来自初级保健。哮喘、哮喘+慢性阻塞性肺病和慢性阻塞性肺病之间的症状、健康相关生活质量和肺活量测定显示出显着的异质性和重叠，分别有 23%、62% 和 64% 的患者使用支气管扩张剂后用力呼气量的比率为 1导致肺活量低于正常下限。症状和加重随着医生评估的严重程度的增加而增加，并且在哮喘+慢性阻塞性肺病中更高。然而，24.3% 的轻度哮喘患者和 20.4% 的轻度 COPD 患者在过去 12 个月内经历过 ≥1 次恶化。用药记录表明，相对于严重程度，治疗不足和过度治疗。血液嗜酸性粒细胞计数在不同诊断和严重程度组之间变化不大，但血液中性粒细胞计数随着所有诊断的严重程度而增加。

该分析表明，哮喘和/或慢性阻塞性肺病患者的医生指定的诊断和严重程度组内部存在明显的异质性，并且之间存在重叠。目前临床实践中的诊断和严重程度分类很难区分可能具有特定风险和治疗意义的临床表型。