A Prognostic Transcriptomic Signature for Chronic Hypersensitivity Pneumonitis

NCT ID: NCT04844359

Last Updated: 2025-05-14

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

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-06

Study Completion Date

2025-07-31

Brief Summary

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Up to 150 patients with hypersensitivity pneumonitis will be enrolled at 7 clinical centers across the United States. Patients will be followed for 24 months to determine if biomarkers in the blood can predict disease progression.

Detailed Description

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Hypersensitivity pneumonitis is an immunologically mediated form of lung disease, resulting from inhalation exposure to a large variety of antigens. For unknown reasons, a subgroup of patients with HP without a known inciting antigen exposure develops chronic disease with progressive pulmonary fibrosis (the leading cause of death). Accurately identifying patients at risk of disease progression is necessary for prognosis and therapy.

Enrolled subjects will be followed for 24 months and complete 5 visits to one of the study centers. Blood biomarkers will be collected in addition to other clinical data to determine if these biomarkers can predict disease progression.

Conditions

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Hypersensitivity Pneumonitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of chronic hypersensitivity pneumonitis
* Age 18 through 85 years.
* Diagnosis of chronic hypersensitivity pneumonitis by HRCT
* Able to understand and sign a written informed consent form.
* Able to understand the importance of adherence to the study protocol and willing to follow all study requirements

Exclusion Criteria

* Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study
* Known explanation for the interstitial lung disease
* Clinical diagnosis of any connective tissue disease
* Listed or expected to receive a lung transplant within 4 months from enrollment
* Pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role collaborator

National Jewish Health

OTHER

Sponsor Role lead

Responsible Party

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Evans Fernandez Perez

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evans Fernández, MD, MS

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status

University of California Davis

Sacramento, California, United States

Site Status

National Jewish Health

Denver, Colorado, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

University of Texas Southwestern

Dallas, Texas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL148437

Identifier Type: NIH

Identifier Source: org_study_id

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