Determining in Vitro Properties of Epithelial Cells From Individuals With Genetic Variants Associated With Idiopathic Pulmonary Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators are trying to understand the role of specific genes in the function of airway surface cells. The investigators know that there are some common genetic markers that are associated with various lung diseases. However, most people with these genetic markers never develop any evidence of lung disease, so it is not understand how or if these markers play a role in disease. Investigators are asking healthy people to provide three (3) tubes of blood as well as a sample of cells from their nose. Investigators will use the blood sample to provide genetic information (specifically, presence or absence of alleles known to be associated with pulmonary fibrosis). Nose cells from individuals with the genetic markers that investigators are studying will be grown in the the lab to allow investigators to learn more about how the cells respond to various forms of environmental stress, such as exposure to cigarette smoke. The goal of this study is to understand how specific genes affect airway cell function.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Idiopathic Pulmonary Fibrosis Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Epithelial cell function of cells from individuals with various genotypes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age greater than 18 years of age
2. Ability to provide informed consent
3. Patent bilateral nares

Exclusion Criteria

1. Significant nasal or sinus disease precluding nasal brushing
2. A history of or ongoing epistaxis (nose-bleeding)
3. Acute upper respiratory illness
4. Ongoing treatment of respiratory or sinus illness with antibiotics
5. Pregnancy
6. Age less than 18 years
7. Infection with human immunodeficiency virus (HIV) or viral hepatitides (Hepatitis B, Hepatitis C)
8. Prior volunteer for the same study
9. Known diagnosis of cystic fibrosis or other ciliary disorder (example: primary ciliar dyskinesia)
10. Treatment with anticoagulants (examples: warfarin/coumadin, low molecular weight heparins, direct thrombin inhibitors such as dabigatran, anti-platelet agents such as P2Y12 inhibitors like clopidogrel and prasugrel, aspirin, ticagrelor, or factor Xa inhibitors such as rivaroxaban)
11. Known thrombocytopenia (example: immune thrombocytopenic purpura)
12. Ongoing chemotherapy
13. Known platelet dysfunction or bleeding diathesis/hemophilia

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David A Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Colorado Denver

Aurora, Colorado, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01HL097163

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-3027

Identifier Type: -

Identifier Source: org_study_id