Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis

Summary

Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that affects an individual's ability to breathe. This study will evaluate the effectiveness of sildenafil, a medication that increases blood flow to the lungs, at improving breathing function, exercise capacity, and quality of life in people with advanced IPF.

Conditions

• Pulmonary Fibrosis
• Hypertension, Pulmonary

Interventions

DRUG

Sildenafil Citrate

Sildenafil citrate (20mg 3 times a day \[TID\] orally for 12 weeks followed by 20mg TID open-label sildenafil for an additional 12 weeks)

OTHER

Placebo

Placebo (20mg TID orally for 12 weeks followed by 20mg open-label sildenafil for 12 weeks)

Sponsors & Collaborators

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

  collaborator NIH

• Pfizer

  collaborator INDUSTRY

• Duke University

  lead OTHER

Principal Investigators

• Gary Hunninghake, MD · University of Iowa

• 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

• David Zisman, MD · University of California, Los Angeles

• Kevin Anstrom, PhD · Duke University

• Herbert Reynolds, MD · National Heart, Lung, and Blood Institute (NHLBI)

• Lake D Morrison, MD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-08-31

Primary Completion

2009-05-31

Completion

2009-10-31

Countries

• United States

Study Locations