A Prognostic Transcriptomic Signature for Chronic Hypersensitivity Pneumonitis

Brief Title

A Prognostic Transcriptomic Signature for Chronic Hypersensitivity Pneumonitis

Official Title

Development and Validation of a Prognostic Transcriptomic Signature for Chronic Hypersensitivity Pneumonitis

Brief Summary

      Up to 135 patients with hypersensitivity pneumonitis will be enrolled at 5 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

      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.
    


Study Type

Observational


Primary Outcome

Time to absolute FVC (percent predicted) decline ≥10 percent


Condition

Hypersensitivity Pneumonitis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

135

Start Date

January 6, 2021

Completion Date

January 2025

Primary Completion Date

January 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of chronic hypersensitivity pneumonitis for at least 3 to 6 months.

          -  Age 18 through 80 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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Evans Fernández, MD, MS, 303-270-2852, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04844359

Organization ID

R01HL148437


Responsible Party

Principal Investigator

Study Sponsor

National Jewish Health

Collaborators

 University of California, Davis

Study Sponsor

Evans Fernández, MD, MS, Principal Investigator, National Jewish Health


Verification Date

April 2021