Table 1. Selected recent clinical trials in idiopathic pulmonary fibrosis.
Trial | Drug (putative MoA) | Patients n | End-point | Outcome |
IFIGENIA | NAC (anti-oxidant; plus prednisone and AZT) | 155 | ΔVC, ΔDL,CO | Positive |
NCT0063869 | Etanercept (TNF antagonist) | 88 | ΔFVC, ΔDL,CO, PA-a,O2 | Negative |
INSPIRE | IFN-γ-1b (antifibrotic) | 826 | Survival | Negative |
BUILD-1 | Bosentan (endothelin inhibitor) | 158 | 6MWT | Negative |
BUILD-3 | Bosentan (endothelin inhibitor) | 600 | Progression-free survival | Negative |
NCT00131274 | Imatinib (tyrosin kinase inhibitor) | 119 | Disease progression or death | Negative |
STEP-IPF | Sildenafil (PD5 inhibitor) | 180 | 6MWT | Negative |
Shionogi phase III | Pirfenidone (antifibrotic) | 267 | ΔVC | Positive |
PIPF 004 (CAPACITY 2) | Pirfenidone (antifibrotic) | 435 | ΔFVC % pred | Positive |
PIPF 006 (CAPACITY 1) | Pirfenidone (antifibrotic) | 344 | ΔFVC % pred | Negative |
MoA: mechanism of action; NAC: N-acetylcysteine; AZT: azathioprine; TNF: tumour necrosis factor; IFN: interferon; PD5: phosphodiesterase-5; VC: vital capacity; DL,CO: diffusing capacity of the lung for carbon monoxide; FVC: forced vital capacity; PA–a,O2: alveolar–arterial oxygen tension difference; 6MWT: 6-min walk test; % pred: % predicted.