Characterization of Apolipoprotein A-I Pathways in Idiopathic Pulmonary Fibrosis

NCT02315586 | Completed

• 2 other identifiers: 15001715-H-0017
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis; Apoliprotein A-1; Natural History

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

Participants will be enrolled at the NIH Clinical Center.

2

IPF subjects will be recruited from the INOVA Fairfax Advanced Lung Disease Program

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be enrolled at the NIH Clinical Center. IPF subjects will be recruited from the INOVA Fairfax Advanced Lung Disease Program and study procedures will be performed in the outpatient unit/day hospital at the NIH Clinical Center.@@@

You may qualify if:

• Patient:
• Males and females over the age of 18 with a diagnosis of IPF.

You may not qualify if:

• Patient:
• Female subjects who are pregnant or lactating
• Normal Volunteer:
• Males and females over the age of 18 without IPF.
• Normal Volunteer:
• Female subjects who are pregnant or lactating

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stewart J Levine, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 12, 2014
• Study Start: January 28, 2015
• Primary Completion: November 2, 2016
• Study Completion: February 23, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)