A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF)

Phase 2 Completed 123 enrolled Hoffmann-La Roche

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2013-08
Primary completion: 2015-02
Completion: 2015-02

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	N-acetylcysteine	Small molecule	600 mg	Oral
Background	Pirfenidone	Small molecule	1602 mg	Oral

A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF)

Summary

Timeline

Drugs

Indications