Hypertension, Pulmonary Clinical Trial
Official title:
Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis
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.
IPF is a disease in which fibrous tissue clogs the lungs. This eventually damages air sacs
in the lungs and leads to widespread and permanent scarring of lung 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,
affects half of all people with IPF. The fibrous tissue that clogs the lungs also blocks
blood from flowing through the lungs effectively, reducing the amount of oxygen in the
lungs. The fibrous tissue also reduces the lungs' ability to use what oxygen is available.
These factors can cause breathing difficulties and may eventually lead to heart disease.
Sildenafil is a medication that can increase blood supply to the lungs and reduce the
heart's workload. The purpose of this study is to evaluate the effectiveness of sildenafil
at improving breathing function, exercise capacity, and quality of life in people with
advanced 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. At all study visits, a physical exam and blood collection will
occur. At selected visits, the following study procedures will occur: lung function testing;
urine collection; a 6-minute walk test, which will measure the distance walked in a 6-minute
period; and questionnaires to assess health status, breathing, and quality of life.
Participants will record medication usage and symptoms in a daily diary. Study researchers
will review medical records and the Social Security death index 5 years following the end of
the study to determine the incidence of death among study participants.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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