Characterization of Apolipoprotein A-I Pathways in Idiopathic Pulmonary Fibrosis

  • STATUS
    Recruiting
Updated on 23 November 2020
ct scan
chest x-ray
x-rays
chest ct
idiopathic pulmonary fibrosis
walk tests

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.

Please visit our Patient Recruitment Page for more information.

 

Description

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.

 

Please visit our Patient Recruitment Page for more information.

Details
Condition Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis
Clinical Study IdentifierTX218176
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

_Patient:_
Males and females over the age of 18 with a diagnosis of IPF
_Normal Volunteer:_
Males and females over the age of 18 without IPF

Exclusion Criteria

_Patient:_
Female subjects who are pregnant or lactating
_Normal Volunteer:_
Female subjects who are pregnant or lactating
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  • You can expect the study team to contact you via email or phone in the next few days.
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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