A Prognostic Transcriptomic Signature for Chronic Hypersensitivity Pneumonitis (PREDICT-HP)

National Jewish Health

Status: Active, not recruiting

Conditions: Hypersensitivity Pneumonitis

Study type: Observational

Funder types: Other

Identifiers

NCT04844359

R01HL148437

Details and patient eligibility

About

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.

Full 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.

Enrollment: 137 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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