This multicentre, randomised, double-blind placebo-controlled trial was designed to address the effectiveness of the antioxidant, N-Acetylcysteine (NAC), alone and in ‘triple’ therapy (prednisolone, azathioprine and NAC) in idiopathic pulmonary fibrosis (IPF).
Patients with IPF and mild to moderate lung function impairment (FVC≥50% and TLCO≥30%) were assigned to receive triple therapy, NAC alone or matched placebo for 60 weeks. Target recruitment was 130 patients per group, however, following a planned interim analysis (mean follow-up 32 weeks) the triple therapy arm (n=77) was halted. Compared with placebo (n=78), increased risks of death (8 vs 1), hospitalisation (23 vs 7), and serious adverse events (24 vs 8) were seen. The placebo and triple therapy groups h...
Conclusion We recognise that this preliminary proposal needs debate, validation and evolution (eg, including ‘omics’ and molecular imaging information in the future), but we hope that it may stimulate debate and research in the field.