Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Fibrosis, Hypertension, Pulmonary

In brief

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.

Key facts

Study ID

NCT00517933

Run by

Duke University

People needed

180

Starts

2007-08-01

Expected to finish

2009-10-01

Last updated by the study team

2015-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of IPF
• Diffusing capacity of the lung (DLCO) level less than 35% (adjusted for hemoglobin)

You may not qualify if…

• Current enrollment in another investigational study
• Six-minute walk distance of less than 50 meters at screening or study entry
• Difference of greater than 15% between the screening and study entry 6-minute walk distance
• Acute or long-term impairment other than dyspnea (e.g., angina pectoris, intermittent claudication) that limits the ability to comply with the 6-minute walk test or other study requirements
• Forced Expiratory Volume 1-second (FEV1)/forced vital capacity (FVC) ratio of less than 0.65 after bronchodilator use
• Extent of emphysema greater than the extent of fibrotic change (e.g., honeycombing, reticular changes) on high-resolution computed tomography (HRCT) scan
• Acute heart attack within the 6 months prior to study entry
• Nitrate use
• Hypersensitivity to sildenafil or any component of the formulation
• Presence of aortic stenosis (AS)
• Life-threatening arrhythmia within 1 month of study entry
• Diabetes mellitus requiring insulin therapy
• Second-degree or third-degree atrioventricular (AV) block on electrocardiogram
• Severe chronic heart failure, defined by left ventricular ejection fraction (LVEF) of less than 25%
• Presence of idiopathic hypertrophic subaortic stenosis (IHSS)
• Hypotension (i.e., systolic blood pressure [SBP] less than 100 mm Hg or diastolic blood pressure [DBP] less than 50 mm Hg)
• Uncontrolled systemic hypertension (i.e., SBP greater than 180 mm Hg or DBP greater than 100 mm Hg)
• Known penile deformities or conditions (e.g., sickle cell anemia, multiple myeloma, leukemia) that may predispose participant to priapism
• Aspartate aminotransferase (AST), serum glutamic pyruvic transaminase (SGPT), alanine aminotransferase (ALT), or serum glutamic oxaloacetic transaminase (SGOT) greater than three times the upper limit of normal range
• Kidney impairment (i.e., creatinine clearance less than 30 mL/minute)
• Current drug or alcohol dependence
• Retinitis pigmentosa
• History of vision loss
• History of nonarteritic ischemic optic neuropathy
• Recently initiated pulmonary rehabilitation within 30 days of study entry. Participants will be prohibited from starting pulmonary rehabilitation during the study. Participants who are currently undergoing maintenance pulmonary rehabilitation at study entry will be asked to maintain their levels of rehabilitation for the duration of the study.

Where it is running

• University of Alabama - Birmingham — Birmingham, Alabama, United States
• University of California - Los Angeles — Los Angeles, California, United States
• University of California - San Francisco — San Francisco, California, United States
• National Jewish Medical and Research Center — Denver, Colorado, United States
• Emory University — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Tulane University — New Orleans, Louisiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Weill Medical College of Cornell University — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Vanderbilt University — Nashville, Tennessee, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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