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Sildenafil to Increase Exercise Capacity in Individuals With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension

Primary Purpose

Pulmonary Fibrosis, Hypertension, Pulmonary

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sildenafil (50 mg)
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Fibrosis focused on measuring Pulmonary Hypertension, Idiopathic Pulmonary Fibrosis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: IPF, diagnosed according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) consensus statement (with or without surgical lung biopsy) Pulmonary hypertension, defined as mean pulmonary artery pressure (MPAP) greater than or equal to 25 mm Hg by right heart catheterization (RHC) Exclusion Criteria: Interstitial lung disease due to conditions other than IPF Recent lung or upper respiratory tract infection within 4 weeks of study entry Acute or chronic impairment other than dyspnea (e.g., angina pectoris, intermittent claudication) limiting the ability to comply with study requirements (e.g., 6-minute walk test) Known hypersensitivity to sildenafil Known or suspected coronary artery disease (CAD) Unstable angina Nitrate use Known or suspected aortic stenosis (AS) Known or suspected heart attack, stroke, or life-threatening arrythmias within 1 month of study entry Severe chronic heart failure, defined as New York Heart Association (NYHA) class III/IV and/or left ventricular ejection fraction less than 25% Known penile deformities Known kidney or liver dysfunction Uncontrolled diabetes (blood glucose less than 60 mg/dl or greater than 300 mg/dl) Severe serum sodium abnormalities (serum sodium less than 130 mEq/L or greater than 150 mEq/L) Condition that may predispose participant to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia) Retinitis pigmentosa Known or suspected idiopathic hypertrophic subaortic stenosis (IHSS) Low blood pressure (systolic blood pressure [SBP] less than 100 mm Hg or diastolic blood pressure [DBP] less than 50 mm Hg) Uncontrolled systemic high blood pressure (SBP greater than 180 mm Hg or DBP greater than 100 mm Hg) Cardiopulmonary rehabilitation program started within 8 weeks of study entry or likely to start prior to the conclusion of the study Treatment with an endothelin receptor antagonist, iloprost, epoprostenol, inhibitors of CYP3A4 (e.g., cimetidine, erythromycin, ketoconazole, itraconazole, mibefradil), protease inhibitors (e.g., amprenavir, indinavir, or ritonavir), rifampin, alpha-blockers (e.g., doxazosin), or other phosphodiesterase-5 inhibitors Current use of alcohol, grapefruit juice, or St. John's wort Pregnant or breastfeeding

Sites / Locations

  • UCLA Pulmonary Outpatient Clinic,

Outcomes

Primary Outcome Measures

6-minute walk distance (measured at Week 3)

Secondary Outcome Measures

Oxygen saturation (SpO2) at rest
Lowest SpO2 with exertion (measured during 6-minute walk test)
Total duration of SpO2 below 89% with exertion (measured during 6-minute walk test)
Recovery time (measured during 6-minute walk test)
Mean SpO2 and area under the curve (measured during 6-minute walk test)
Desaturation index (measured by the 6-minute walk distance multiplied by the SpO2 mean value)
Level of breathlessness (measured by Borg dyspnea index questionnaire) (all measured at Week 3)

Full Information

First Posted
July 13, 2006
Last Updated
July 28, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00352482
Brief Title
Sildenafil to Increase Exercise Capacity in Individuals With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension
Official Title
Sildenafil Treatment in Patients With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - a Pilot Cross-over Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

5. Study Description

Brief Summary
Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that affects an individual's 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Fibrosis, Hypertension, Pulmonary
Keywords
Pulmonary Hypertension, Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sildenafil (50 mg)
Primary Outcome Measure Information:
Title
6-minute walk distance (measured at Week 3)
Secondary Outcome Measure Information:
Title
Oxygen saturation (SpO2) at rest
Title
Lowest SpO2 with exertion (measured during 6-minute walk test)
Title
Total duration of SpO2 below 89% with exertion (measured during 6-minute walk test)
Title
Recovery time (measured during 6-minute walk test)
Title
Mean SpO2 and area under the curve (measured during 6-minute walk test)
Title
Desaturation index (measured by the 6-minute walk distance multiplied by the SpO2 mean value)
Title
Level of breathlessness (measured by Borg dyspnea index questionnaire) (all measured at Week 3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: IPF, diagnosed according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) consensus statement (with or without surgical lung biopsy) Pulmonary hypertension, defined as mean pulmonary artery pressure (MPAP) greater than or equal to 25 mm Hg by right heart catheterization (RHC) Exclusion Criteria: Interstitial lung disease due to conditions other than IPF Recent lung or upper respiratory tract infection within 4 weeks of study entry Acute or chronic impairment other than dyspnea (e.g., angina pectoris, intermittent claudication) limiting the ability to comply with study requirements (e.g., 6-minute walk test) Known hypersensitivity to sildenafil Known or suspected coronary artery disease (CAD) Unstable angina Nitrate use Known or suspected aortic stenosis (AS) Known or suspected heart attack, stroke, or life-threatening arrythmias within 1 month of study entry Severe chronic heart failure, defined as New York Heart Association (NYHA) class III/IV and/or left ventricular ejection fraction less than 25% Known penile deformities Known kidney or liver dysfunction Uncontrolled diabetes (blood glucose less than 60 mg/dl or greater than 300 mg/dl) Severe serum sodium abnormalities (serum sodium less than 130 mEq/L or greater than 150 mEq/L) Condition that may predispose participant to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia) Retinitis pigmentosa Known or suspected idiopathic hypertrophic subaortic stenosis (IHSS) Low blood pressure (systolic blood pressure [SBP] less than 100 mm Hg or diastolic blood pressure [DBP] less than 50 mm Hg) Uncontrolled systemic high blood pressure (SBP greater than 180 mm Hg or DBP greater than 100 mm Hg) Cardiopulmonary rehabilitation program started within 8 weeks of study entry or likely to start prior to the conclusion of the study Treatment with an endothelin receptor antagonist, iloprost, epoprostenol, inhibitors of CYP3A4 (e.g., cimetidine, erythromycin, ketoconazole, itraconazole, mibefradil), protease inhibitors (e.g., amprenavir, indinavir, or ritonavir), rifampin, alpha-blockers (e.g., doxazosin), or other phosphodiesterase-5 inhibitors Current use of alcohol, grapefruit juice, or St. John's wort Pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A. Zisman, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Pulmonary Outpatient Clinic,
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17356110
Citation
Collard HR, Anstrom KJ, Schwarz MI, Zisman DA. Sildenafil improves walk distance in idiopathic pulmonary fibrosis. Chest. 2007 Mar;131(3):897-899. doi: 10.1378/chest.06-2101.
Results Reference
derived
Links:
URL
http://www.coalitionforpf.org
Description
Click here for the Coalition for Pulmonary Fibrosis web site

Learn more about this trial

Sildenafil to Increase Exercise Capacity in Individuals With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension

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