Characterization of Apolipoprotein A-I Pathways in Idiopathic Pulmonary Fibrosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

  • -

    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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02315586
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Stewart J Levine, M.D.
Principal Investigator Affiliation National Heart, Lung, and Blood Institute (NHLBI)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Study Website: View Trial Website
Additional Details

Idiopathic Pulmonary Fibrosis (IPF) is a chronic progressive disease that occurs primarily in older individuals, 55 to 75 years of age, with a median survival of approximately 3 years from time of diagnosis. At present, there are no effective treatments for patients with IPF. Levels of apolipoprotein A-I (apoA-I) have been found to be reduced in the lungs of patients with IPF, while administration of human apoA-I has been shown to reduce bleomycin-induced collagen deposition in a murine model. Here, we would like to assess whether apoA-I pathways modify lung cell biology in patients with IPF. This is a specimen procurement, clinical phenotyping and genotyping protocol that will assess whether holo-apoA-I and apolipoprotein A-I mimetic peptides, can attenuate key pathogenic manifestations of IPF, such as proliferation and extracellular matrix generation by pulmonary fibroblasts, which may serve as evidence to support future human clinical trials of apoA-I for the treatment of IPF. Furthermore, the identification of new apoA-I responsive genes and pathways that mediate fibroblast proliferation in IPF may provide insights into disease pathogenesis and identify new therapeutic targets. Lastly, if induced pluripotent stem (iPS) cells can be successfully shown to model responsiveness of lung cells to apoA-I therapy, then this approach may be expanded with the goal of providing a personalized medicine analysis that could in the future guide selection of the most effective therapy for individual patients.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bethesda, Maryland

Status

Recruiting

Address

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892

Site Contact

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

prpl@cc.nih.gov

800-411-1222 #TTY8664111010

Terms of Service

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