Table 1.
Patient group | Rationale |
383 patients with COPD, including:
|
Included to provide data on increased lung protease levels and the contribution that this may have on the development and progression of emphysema in the absence of A1ATD. |
18 patients with COPD and A1ATD§ | Included as they present with an earlier onset of emphysema and a faster decline in lung function, as well as a faster change in lung density.9 |
62 ex-smokers without airflow limitation | Included to provide a comparison for biomarkers between subjects with and without airflow limitation. Subjects were required to be healthy based on a complete medical history and to have: FEV1 ≥80% of predicted normal and post-bronchodilator. FEV1/forced vital capacity ≥lower limit of normal. A mean post DLCO ≥70% of predicted normal at visit 1. |
Total enrolled: 463 subjects |
*Defined as GOLD stage 1, FEV1 ≥80% predicted.25
†Defined as GOLD stage 2, FEV1 ≥50–<80% predicted.25
‡Defined as GOLD stage 3, FEV1 ≥30–<50% predicted.25
§Ddefined as having a diagnosis of COPD and a documented A1ATD of ZZ genotype prior to visit 2.
A1ATD, alpha1-antitrypsin deficiency; COPD, chronic obstructive pulmonary disease; DLCO, diffusing capacity of the lungs for carbon monoxide; FEV1, forced expiratory volume in 1 s; GOLD, Global Initiative for Chronic Obstructive Lung Disease; ZZ, ZZ allele.