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Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis (STEP-IPF)

Trial Location:
Main Campus, Denver, CO
Principal Investigator:

Kevin K. Brown, MD

Trial Objective:

Idiopathic Pulmonary Fibrosis (IPF) is a disease in which the lung is gradually replaced by scar tissue. Individuals with IPF may experience breathing difficulties, cough, chest pain, and a decreased exercise capacity. Pulmonary hypertension, which is high blood pressure in the arteries of the lungs, is thought to effect many individuals with IPF.

The purpose of the study is to determine if sildenafil improves breathing, exercise capacity or quality of life. Sildenafil is commonly known as revatio or viagra. Sildenafil is a medication that can increase blood supply to the lungs and reduce the heart''s workload. Sildenafil is approved by the United States Food and Drug Administration (FDA) to treat erectile dysfunction and pulmonary arterial hypertension. Sildenifil is not approved by the FDA to treat IPF. The use of Sildenifil in this study is investigational. There is no known treatment for IPF. No drugs are approved by the FDA for treating IPF, so any treatments given are considered experimental. This study is designed to see if sildenafil works better than placebo (a pill that contains no active medication) to treat IPF. This study will enroll people with advanced IPF.

Participants will be randomly assigned to receive sildenafil or placebo three times a day for 12 weeks. Study visits will occur at baseline and Weeks 1, 6, and 12. At Week 12, participants will have the option to continue in the study for an additional 12 weeks. All participants who agree to continue in the study will receive sildenafil three times a day for the second 12 weeks. Study visits will occur at Weeks 13, 18, and 24.

Inclusion Criteria:

  • Clinical diagnosis of IPF
  • DLCO level less than 35% of predicted (adjusted for hemoglobin)
Compensation:

Not Provided

Enrollment:

Completed and Research Published