Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
Characterization of Apolipoprotein A-I Pathways in Idiopathic Pulmonary Fibrosis
Verified date | February 7, 2024 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background: - Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that becomes worse over time. There is currently no effective treatment for it. Researchers want to study the disease and learn new ways to treat it. Objectives: - To discover new pathways that are involved in pulmonary fibrosis. To develop new drugs that may be used to treat pulmonary fibrosis. Eligibility: - People at least 18 years old with IPF. - Healthy volunteers at least 18 years old. Design: - Participants will be screened with medical history, questionnaire, and physical exam. They will have blood, lung, and walking tests and chest scans. - All participants will have 1 study visit, including: - Medical history and physical exam. - Questions about their breathing. - Blood tests. - Breathing tests. - Six-minute walk test. - Pregnancy test. - Chest x-ray (healthy volunteers) or chest CT scan (people with pulmonary fibrosis ). - Small area of skin may be removed. - Genetic tests of blood and skin samples. Participants will probably not be informed of any findings. Samples may be used to make stem cells for use in research. Participants may be contacted in the future to give consent for this research. - Some participants will have repeat visits over many years, repeating many of the study tests.
Status | Completed |
Enrollment | 63 |
Est. completion date | February 23, 2022 |
Est. primary completion date | November 2, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | - INCLUSION CRITERIA: Patient: Males and females over the age of 18 with a diagnosis of IPF. EXCLUSION CRITERIA: Patient: Female subjects who are pregnant or lactating INCLUSION CRITERIA: Normal Volunteer: Males and females over the age of 18 without IPF. EXCLUSION CRITERIA: Normal Volunteer: Female subjects who are pregnant or lactating |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Specimen procurement, clinical phenotyping and genotyping that will assess whether holo-apoA-I and apolipoprotein A-I mimetic peptides, can attenuate key pathogenic manifestations of IPF | Therefore, we request participation of a maximum of 500 subjects (250 IPF patients and 250 non-IPF subjects) to ensure that we have a sufficient number of samples to achieve the goals of the study. | 5 years | |
Secondary | The effects of stimulating cultures of primary pulmonary fibroblasts from IPF patients and subjects without IPF with apolipoprotein A-I will also be compared to the effects seen following stimulation with apolipoprotein E | 5 years |
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