Key baseline characteristics of patients in the INPULSIS trials (reproduced with permission from ref. 18
| Nintedanib (n=638) | Placebo (n=423) | |
| Male, n (%) | 507 (79.5) | 334 (79.0) |
| Age, years, mean (SD) | 66.6 (8.1) | 67.0 (7.9) |
| Weight, kg, mean (SD) | 79.2 (16.6) | 78.6 (16.5) |
| Race, n (%) | ||
| White | 360 (56.4) | 248 (58.6) |
| Asian | 194 (30.4) | 128 (30.3) |
| Black | 2 (0.3) | 0 (0.0) |
| Missing* | 82 (12.9) | 47 (11.1) |
| Smoking status, n (%) | ||
| Ex-smoker | 435 (68.2) | 283 (66.9) |
| Current smoker | 29 (4.5) | 18 (4.3) |
| Never smoked | 174 (27.3) | 122 (28.8) |
| Time since diagnosis of IPF, years, mean (SD)† | 1.7 (1.4) | 1.6 (1.3) |
| FVC, mL, mean (SD) | 2714 (757) | 2728 (810) |
| FVC, % predicted, mean (SD) | 79.7 (17.6) | 79.3 (18.2) |
| FEV1/FVC ratio, %, mean (SD) | 81.7 (5.8) | 81.7 (6.0) |
| DLCO, % predicted, mean (SD) | 47.4 (13.5) | 47.0 (13.4) |
| SpO2, %, mean (SD) | 95.9 (2.3) | 95.8 (2.0) |
| SGRQ total score, mean (SD)† | 39.5 (19.2) | 39.6 (18.5) |
Based on patients who received ≥1 dose of study medication. Data collected at screening except for time since diagnosis of IPF, which was collected at randomisation.
*It was not permitted to collect data on race in France.
†n=624 for nintedanib 150 mg twice daily and n=419 for placebo.
DLco, diffusion capacity of the lung for carbon monoxide; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; IPF, idiopathic pulmonary fibrosis; SGRQ, St. George's Respiratory Questionnaire; SpO2, oxygen saturation.