At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 264 enrolled

Drug / intervention

N-acetylcysteine (NAC) +1 moredrug

Likely dose

N-acetylcysteine (NAC) 600 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00650091

NCT00650091Phase 3Completed

Compare CT.gov

Prednisone, Azathioprine, and N-acetylcysteine: A Study That Evaluates Response in IPF

Duke University·interventional·Posted Apr 1, 2008·Updated Jun 2, 2015

In Brief

A Phase 3 clinical trial evaluating N-acetylcysteine (NAC) and Placebo for Pulmonary Fibrosis. Completed, enrolled 264 participants across 26 sites.

Detailed Summary

Idiopathic pulmonary fibrosis (IPF) is a long-term lung disease that affects an individual's ability to breathe. In this randomized, double-blind, placebo-controlled trial, we assigned patients with idiopathic pulmonary fibrosis who had mild-to-moderate lung-function impairment to one of three groups - receiving a combination of prednisone, azathioprine, and NAC (combination therapy), NAC alone, or placebo - in a 1:1:1 ratio.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPulmonary Fibrosis

CountriesUnited States

CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 3CompletedFinished

20082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedApr 2008

Enrollment StartOct 2009

Primary CompletionOct 2013

Study CompletionJan 2014

TodayJul 2026

First PostedApr 1, 2008

Enrollment StartOct 1, 2009

Primary CompletionOct 1, 2013

Study CompletionJan 1, 2014

TodayJul 2, 2026

Enrollment to primary: 4 yearsPosted 18.3 years ago

Interventions

N-acetylcysteine (NAC)drug

Participants will receive 600 mg of NAC three times a day.

Placebodrug

Participants will receive placebo each day.