- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00352482
Sildenafil to Increase Exercise Capacity in Individuals With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension
Sildenafil Treatment in Patients With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - a Pilot Cross-over Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA Pulmonary Outpatient Clinic,
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
6-minute walk distance (measured at Week 3)
|
Secondary Outcome Measures
Outcome Measure |
---|
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)
|
Collaborators and Investigators
Investigators
- Principal Investigator: David A. Zisman, MD, University of California, Los Angeles
Publications and helpful links
General Publications
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Fibrosis
- Hypertension
- Pulmonary Fibrosis
- Idiopathic Pulmonary Fibrosis
- Hypertension, Pulmonary
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Phosphodiesterase Inhibitors
- Phosphodiesterase 5 Inhibitors
- Sildenafil Citrate
Other Study ID Numbers
- 414
- P50HL067665-05 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pulmonary Fibrosis
-
St. Antonius HospitalZonMw: The Netherlands Organisation for Health Research and Development; Boeringer...RecruitingPulmonary Fibrosis Idiopathic FamilialNetherlands
-
Wake Forest University Health SciencesMayo Clinic; The University of Texas Health Science Center at San AntonioCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
-
Sheba Medical CenterUnknownIDIOPATHIC PULMONARY FIBROSISIsrael
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, FranceRecruitingIdiopathic Pulmonary Fibrosis | Pulmonary Disease | Pulmonary MedicineFrance
-
Theravance BiopharmaTerminatedIdiopathic Pulmonary Fibrosis (IPF)United Kingdom
-
University of California, San FranciscoCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
-
BiogenCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
-
Liminal BioSciences Ltd.CompletedIdiopathic Pulmonary Fibrosis (IPF)Canada
-
Centre Hospitalier Universitaire de NiceRecruitingPulmonary Disease, Chronic Obstructive | Interstitial Pulmonary FibrosisFrance
-
Angion Biomedica CorpNot yet recruitingIdiopathic Pulmonary Fibrosis (IPF)
Clinical Trials on Sildenafil (50 mg)
-
University of AlbertaRecruiting
-
Ain Shams UniversityDrug Research Centre, Cairo, EgyptCompletedSmoking | Erectile Dysfunction | Pharmacokinetics | PharmacodynamicsEgypt
-
IBSA Institut Biochimique SARecruiting
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedHealthy VolunteersUnited States
-
Strategic Science & Technologies, LLCCompleted
-
University of Roma La SapienzaCompletedDiabetes Mellitus, Type 2 | Endothelial DysfunctionItaly
-
University of Alabama at BirminghamUniversity Teaching Hospital, Lusaka, Zambia; Cameroon Baptist Convention Health and other collaboratorsNot yet recruitingDevelopment, Infant | Neonatal Asphyxia | Intrapartum Fetal Distress | Intrapartum AsphyxiaZambia, Cameroon, Kenya
-
Zydus Lifesciences LimitedRecruitingAmyotrophic Lateral SclerosisIndia
-
ViiV HealthcareGlaxoSmithKline; Janssen PharmaceuticalsCompletedInfection, Human Immunodeficiency VirusUnited States