Baseline characteristics of patients who had or did not have at least one investigator-reported acute exacerbation
| Patients with investigator-reported acute exacerbation | Patients with no investigator-reported acute exacerbation | |
| Patients | 69 | 992 |
| Age years | 69.1±7.3 | 66.6±8.1 |
| Male | 58 (84.1%) | 783 (78.9%) |
| Race | ||
| Asian | 20 (29.0%) | 302 (30.4%) |
| Other (white/black/missing#) | 49 (71.0%) | 690 (69.6%) |
| Weight kg | 76.7±17.8 | 79.2±16.5 |
| Ex- or current smoker | 53 (76.8%) | 712 (71.8%) |
| Concomitant medications | ||
| Corticosteroids | 17 (24.6%) | 208 (21.0%) |
| Bronchodilators | 11 (15.9%) | 190 (19.2%) |
| Proton pump or histamine receptor-2 inhibitor | 33 (47.8%) | 373 (37.6%) |
| Supplemental oxygen | 16 (23.2%) | 76 (7.7%) |
| Emphysema¶ | 22 (31.9%) | 398 (40.1%) |
| Honeycombing on HRCT | 39 (56.5%) | 528 (53.2%) |
| FVC mL | 2303±617 | 2748±780 |
| FVC % predicted | 68.8±14.6 | 80.3±17.8 |
| FEV1/FVC ratio % | 84.0±5.6 | 81.5±5.9 |
| DLCO % predicted | 43.2±17.2 | 47.5±13.1 |
| SGRQ total score | 49.1±18.0 | 38.9±18.8 |
Data are presented as mean±sd, unless otherwise indicated. HRCT: high-resolution computed tomography; FVC: forced vital capacity; FEV1: forced expiratory volume in 1 s; DLCO: diffusing capacity of the lung for carbon monoxide; SGRQ: St George's Respiratory Questionnaire. Patients were categorised into subgroups depending on whether, between randomisation and the end of the post-treatment follow-up period, they experienced or did not experience an investigator-reported acute exacerbation. #: in France, regulations do not permit the collection of data on race; ¶: based on qualitative assessment of HRCT scans.