Table 1 Trial designs
Trial | Key inclusion criteria | Randomised treatment | Duration |
|---|---|---|---|
TOMORROW (NCT00514683) [8] | ≥ 40 years of age FVC ≥ 50% predicted DLco 30%–79% predicted | Placebo, nintedanib 50 mg qd, nintedanib 50 mg bid, nintedanib 100 mg bid, or nintedanib 150 mg bid | Period 1: 52 weeks Period 2: Patients who completed 52 weeks’ treatment in period 1 continued treatment until the last patient had completed 52 weeks’ treatment in period 1 |
INPULSIS-1 and -2 (NCT01335464, NCT01335477) [9] | ≥ 40 years of age FVC ≥ 50% predicted DLco 30–79% predicted | Nintedanib 150 mg bid or placebo | 52 weeks |
INMARK (NCT02788474) [10] | ≥ 40 years of age FVC ≥ 80% predicted | Nintedanib 150 mg bid or placebo | 12 weeks’ randomised treatment followed by open-label nintedanib for 40 weeks |
Phase IIIb trial (NCT01979952) [11] | ≥ 40 years of age FVC ≥ 50% predicted DLco 30–79% predicted | Nintedanib 150 mg bid or placebo | ≥ 6 months’ randomised treatment followed by open-label nintedanib up to week 52 |