A Prognostic Transcriptomic Signature for Chronic Hypersensitivity Pneumonitis

N/AActive Not RecruitingNCT04844359

National Jewish Health137 enrolled

Overview

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.

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

Enrollment

137

Conditions

Hypersensitivity Pneumonitis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (7)

University of Arizona

Tucson, Arizona, United States

University of California Davis

Sacramento, California, United States

National Jewish Health

Denver, Colorado, United States

University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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

Time frame: Up to 24 months

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

Time frame: Up to 24 months

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

Time frame: Up to 24 months

Time to relative DLCO (percent predicted) decline ≥10 percent

Time frame: Up to 24 months

Time to relative DLCO (percent predicted) decline ≥15 percent

Time frame: Up to 24 months

Time to first adjudicated acute chronic hypersensitivity pneumonitis exacerbation

Time frame: Up to 24 months

Need for a new course of oral or intravenous steroids

Time frame: Up to 24 months

Time to death from any cause

Time frame: Up to 24 months

Change from baseline in St. George's Respiratory Questionnaire total score at month 6

The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.

Time frame: 6 months

Change from baseline in St. George's Respiratory Questionnaire total score at month 12

The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.

Time frame: 12 months

Data from ClinicalTrials.gov

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Mayo Clinic

Rochester, Minnesota, United States

University of Texas Southwestern

Dallas, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Change from baseline in St. George's Respiratory Questionnaire total score at month 18

The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.

Time frame: 18 months

Change from baseline in St. George's Respiratory Questionnaire total score at month 24

The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.

Time frame: 24 months

Change from baseline in dyspnea using University of California San Diego Shortness of Breath Questionnaire at month 6

Scores range from 0 to 120, with higher scores indicating greater breathlessness.

Time frame: 6 months

Change from baseline in dyspnea using University of California San Diego Shortness of Breath Questionnaire at month 12

Scores range from 0 to 120, with higher scores indicating greater breathlessness.

Time frame: 12 months

Change from baseline in dyspnea using University of California San Diego Shortness of Breath Questionnaire at month 18

Scores range from 0 to 120, with higher scores indicating greater breathlessness.

Time frame: 18 months

Change from baseline in dyspnea using University of California San Diego Shortness of Breath Questionnaire at month 24

Scores range from 0 to 120, with higher scores indicating greater breathlessness.

Time frame: 24 months

Change from baseline in dyspnea using St. George's Respiratory Questionnaire symptoms score at month 6

The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.

Time frame: 6 months

Change from baseline in dyspnea using St. George's Respiratory Questionnaire symptoms score at month 12

The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.

Time frame: 12 months

Change from baseline in dyspnea using St. George's Respiratory Questionnaire symptoms score at month 18

The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.

Time frame: 18 months

Change from baseline in dyspnea using St. George's Respiratory Questionnaire symptoms score at month 24

The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.

Time frame: 24 months

Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 6

The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.

Time frame: 6 months

Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 12

Time frame: 12 months

Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 18

The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.

Time frame: 18 months

Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 24

The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.

Time frame: 24 months

Change from baseline in dyspnea using St. George's Respiratory Questionnaire impact score at month 6

The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.

Time frame: 6 months

Change from baseline in dyspnea using St. George's Respiratory Questionnaire impact score at month 12

The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.

Time frame: 12 months

Change from baseline in dyspnea using St. George's Respiratory Questionnaire impact score at month 18

The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.

Time frame: 18 months

Change from baseline in dyspnea using St. George's Respiratory Questionnaire impact score at month 24

The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.

Time frame: 24 months

Change from baseline in CT visual (≥10 percent) score at month 12

Visual scores range from 0 to 100, with higher scores indicating more lung fibrosis.

Time frame: 12 months

Change from baseline in CT visual (≥10 percent) score at month 24

Visual scores range from 0 to 100, with higher scores indicating more lung fibrosis.

Time frame: 24 months

Change from baseline in CT quantitative (≥3.4) score at month 12

CT quantitative scores range from 0 to no upper limits, with higher scores indicating more lung fibrosis.

Time frame: 12 months

Change from baseline in CT quantitative (≥3.4) score at month 24

CT quantitative scores range from 0 to no upper limits, with higher scores indicating more lung fibrosis.

Time frame: 24 months

Change from baseline in 6-min walk distance at month 6

Time frame: 6 months

Change from baseline in 6-min walk distance at month 12

Time frame: 12 months

Change from baseline in 6-min walk distance at month 18

Time frame: 18 months

Change from baseline in 6-min walk distance at month 24

Time frame: 24 months

Rate of decline in FVC (percent predicted) over 24 months

Time frame: Up to 24 months

Rate of decline in FVC (ml) over 24 months

Time frame: Up to 24 months

Rate of decline in DLCO (percent predicted) over 24 months

Time frame: Up to 24 months

Rate of decline in DLCO (mmol/min/kpa) over 24 months

Time frame: Up to 24 months