Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352482
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2006-07-13
Brief Title:
Sildenafil to Increase Exercise Capacity in Individuals With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
Sildenafil Treatment in Patients With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - a Pilot Cross-over Study
Status:
COMPLETED
Status Verified Date:
2007-12
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:
None
Brief Summary:
Idiopathic pulmonary fibrosis IPF is a chronic lung disease that affects an individuals ability to breathe Currently no medications can reverse the damage to the lungs caused by IPF but individuals are encouraged to engage in moderate exercise to strengthen lung function This study will evaluate the effectiveness of sildenafil at improving exercise tolerance and breathing difficulties in individuals with IPF
Detailed Description:
IPF is a disease that damages the 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 There is no cure for this disease and individuals usually die within 3 to 5 years It is recommended that individuals with IPF engage in moderate exercise as this can help maintain strength and improve lung function Many individuals with IPF also suffer from pulmonary hypertension which is high blood pressure in the arteries leading to the lungs Sildenafil a medication currently used to treat pulmonary hypertension increases blood flow to the lungs and enhances gas exchange within the lungs The purpose of this study is to evaluate the effectiveness of sildenafil at improving exercise tolerance and breathing difficulties in individuals with IPF and pulmonary hypertension
This 3-week study will enroll individuals with IPF and pulmonary hypertension Study visits will occur at baseline and Weeks 1 and 2 At the baseline visit participants will perform a 6-minute walk test which will measure the distance walked in a 6-minute period Oxygen levels will be measured prior to and during the test and standardized questionnaires will be completed to assess breathing difficulties A second 6-minute walk test will be performed 1 hour following the first test At the Week 1 visit participants will be randomly assigned to receive a single dose of either 50 mg of sildenafil or placebo One hour after receiving the medication they will complete another 6-minute walk test The Week 2 visit will be identical to the Week 1 visit except participants who received sildenafil at Week 1 will receive placebo at Week 2 and vice versa
This 3-week study will enroll individuals with IPF and pulmonary hypertension Study visits will occur at baseline and Weeks 1 and 2 At the baseline visit participants will perform a 6-minute walk test which will measure the distance walked in a 6-minute period Oxygen levels will be measured prior to and during the test and standardized questionnaires will be completed to assess breathing difficulties A second 6-minute walk test will be performed 1 hour following the first test At the Week 1 visit participants will be randomly assigned to receive a single dose of either 50 mg of sildenafil or placebo One hour after receiving the medication they will complete another 6-minute walk test The Week 2 visit will be identical to the Week 1 visit except participants who received sildenafil at Week 1 will receive placebo at Week 2 and vice versa
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 |
|---|---|---|---|
| P50HL067665-05 | NIH | None | httpsreporternihgovquickSearchP50HL067665-05 |