Table 1.

Main clinical trials on pirfenidone and nintedanib in idiopathic pulmonary fibrosis (IPF).

Study (References)	Design	Treatment	Main Endpoints	Patients
CAPACITY 004 [32]	Phase 3 Randomized Parallel Assignment Double-Blind	Pirfenidone (2403 mg or 1197 mg) versus Placebo	Absolute Change in Percentage of predicted FVC   Mean Change in Percent Predicted FVC as measured from baseline to week 72	435
CAPACITY 006 [32]	Phase 3 Randomized Parallel Assigment Double-Blind	Pirfenidone (2403 mg) versus Placebo	Change in percentage of predicted FVC at week 72	344
ASCEND [33]	Phase 3 Randomized Parallel Assigment Double-Blind	Pirfenidone (2403 mg) versus Placebo	Change in FVC or death at week 52	555
RELIEF [34]	Phase 2 Randomized Parallel assignment Double blinded	Pirfenidone (267 mg or 534 mg or 801 mg) versus placebo	Absolute change in percentage of predicted FVC at week 48	127
TOMORROW [35]	Phase 2 Randomized Parallel assignment Double blinded	Nintedanib (50 mg,100 mg, 200 mg or 300 mg) versus Placebo	Annual rate of decline in FVC over 52 weeks	432
INPULSIS 1- INPULSIS 2 [36]	Phase 3 Randomized Parallel assignment Double blinded	Nintedanib (200 mg or 300 mg) versus Placebo	Annual rate of decline in FVC over 52 weeks	1066
SENSCIS [37]	Phase 3 Randomized Parallel assigment Double blinded	Nintedanib (150 mg) versus placebo	Annual rate of decline in FVC over 52 weeks	576
INBUILD [38]	Phase 3 Randomized Parallel assigment Double blinded	Nintedanib (150 mg) versus placebo	Annual rate of decline in FVC over 52 weeks	663
INJOURNEY [39]	Phase 4 Randomized Parallel assignment Open-label	Nintedanib (150 mg) versus Pirfenidone (2403 mg)	Percentage of patients with on-treatment gastrointestinal AEs from baseline to week 12	105

Abbreviations: FVC: forced vital capacity. AE: Adverse Events.