Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF

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.

Conditions

• Pulmonary Fibrosis

Interventions

DRUG

N-acetylcysteine (NAC)

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

DRUG

Placebo

Participants will receive placebo each day.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Duke University

  lead OTHER

Principal Investigators

• Marvin I Schwarz, MD · University of Colorado, Denver

• Kevin Brown, MD · National Jewish Health

• Rob Kaner, MD · Weill Medical College at Cornell University

• Talmadge King, MD · University of California, San Francisco

• Joe Lasky, MD · Tulane University

• James Loyd, MD · Vanderbilt University

• Fernando Martinez, MD · University of Michigan

• Imre Noth, MD · University of Chicago

• Ganesh Raghu, MD · University of Washington

• Jesse Roman, MD · Emory University

• Jay Ryu, MD · Mayo Clinic

• John Belperio, MD · University of California, Los Angeles

• Kevin Anstrom, PhD · Duke University

• Gail Weinmann, MD · National Heart, Lung, and Blood Institute (NHLBI)

• Jeffrey Chapman, MD · The Cleveland Clinic

• Lake Morrison, MD · Duke University

• Michael Kallay, MD · Highland Hospital

• Steven Sahn, MD · Medical University of South Carolina

• Marilyn Glassberg, MD · University of Miami

• Milton Rossman, MD · University of Pennsylvania

• John Fitzgerald, MD · University of Texas

• Mary Beth Scholand, MD · University of Utah

• Neil Ettinger, MD · St. Luke's Hospital

• Danielle Antin-Ozerkis, MD · Yale University

• Joao deAndrade, MD · University of Alabama at Birmingham

• Ivan Rosas, MD · Brigham and Women's

• Joseph Zibrak, MD · Beth Isreal-Deaconess

• Gerald Criner, MD · Temple University

• Maria Padilla, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-10-31

Primary Completion

2013-10-31

Completion

2014-01-31

Countries

• United States

Study Locations