Conditions: Idiopathic Pulmonary Fibrosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 123
Healthy volunteers: no

Brief summary:
This is a Phase 2, randomized, double-blind, placebo-controlled safety and tolerability study of N-acetylcysteine or placebo in participants with mild to moderate idiopathic pulmonary fibrosis (IPF) receiving background pirfenidone therapy.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: Background therapy

Interventions: intervention 1: Matching Placebo intervention 2: N-acetylcysteine intervention 3: Pirfenidone
Intervention descriptions: intervention 1: Matching Placebo, oral administration, three times daily for 24 weeks. intervention 2: N-acetylcysteine, 600 mg, oral administration, three times daily for 24 weeks. intervention 3: Pirfenidone, at least 1602 mg/day, oral administration, for 32 weeks, during the wash-out and screening period and for at least 8 weeks prior to randomization.

Protocol document: