Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517933
Status:
COMPLETED
Last Update Posted:
2015-06-24
First Post:
2007-08-15
Brief Title:
Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEP-IPF
Brief Summary:
Idiopathic pulmonary fibrosis IPF is a chronic lung disease that affects an individuals 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
Detailed Description:
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 hearts 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 507 | US NIH GrantContract | None | httpsreporternihgovquickSearchU10HL080413 |
| U10HL080413 | NIH | None | None |