A Prognostic Transcriptomic Signature for Chronic Hypersensitivity Pneumonitis
- Conditions
- Hypersensitivity Pneumonitis
- Registration Number
- NCT04844359
- Lead Sponsor
- National Jewish Health
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 137
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to absolute FVC (percent predicted) decline ≥10 percent Up to 24 months Time to relative DLCO (percent predicted) decline ≥15 percent Up to 24 months Change from baseline in St. George's Respiratory Questionnaire total score at month 6 6 months The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.
Change from baseline in St. George's Respiratory Questionnaire total score at month 24 24 months The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.
Change from baseline in dyspnea using University of California San Diego Shortness of Breath Questionnaire at month 6 6 months Scores range from 0 to 120, with higher scores indicating greater breathlessness.
Change from baseline in dyspnea using St. George's Respiratory Questionnaire symptoms score at month 6 6 months The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.
Change from baseline in dyspnea using St. George's Respiratory Questionnaire symptoms score at month 12 12 months The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.
Time to absolute DLCO (percent predicted) decline ≥10 percent Up to 24 months Time to relative DLCO (percent predicted) decline ≥10 percent Up to 24 months Time to first adjudicated acute chronic hypersensitivity pneumonitis exacerbation Up to 24 months Change from baseline in dyspnea using St. George's Respiratory Questionnaire impact score at month 6 6 months The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.
Change from baseline in dyspnea using St. George's Respiratory Questionnaire impact score at month 12 12 months The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.
Change from baseline in CT visual (≥10 percent) score at month 24 24 months Visual scores range from 0 to 100, with higher scores indicating more lung fibrosis.
Rate of decline in DLCO (percent predicted) over 24 months Up to 24 months Change from baseline in St. George's Respiratory Questionnaire total score at month 12 12 months The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.
Time to relative FVC (percent predicted) decline ≥10 percent Up to 24 months Need for a new course of oral or intravenous steroids Up to 24 months Change from baseline in dyspnea using University of California San Diego Shortness of Breath Questionnaire at month 12 12 months Scores range from 0 to 120, with higher scores indicating greater breathlessness.
Change from baseline in dyspnea using St. George's Respiratory Questionnaire symptoms score at month 18 18 months The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.
Change from baseline in dyspnea using St. George's Respiratory Questionnaire symptoms score at month 24 24 months The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.
Change from baseline in CT quantitative (≥3.4) score at month 24 24 months CT quantitative scores range from 0 to no upper limits, with higher scores indicating more lung fibrosis.
Change from baseline in 6-min walk distance at month 12 12 months Rate of decline in FVC (percent predicted) over 24 months Up to 24 months Time to death from any cause Up to 24 months Change from baseline in St. George's Respiratory Questionnaire total score at month 18 18 months The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.
Change from baseline in dyspnea using University of California San Diego Shortness of Breath Questionnaire at month 24 24 months Scores range from 0 to 120, with higher scores indicating greater breathlessness.
Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 6 6 months The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.
Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 12 12 months Change from baseline in CT visual (≥10 percent) score at month 12 12 months Visual scores range from 0 to 100, with higher scores indicating more lung fibrosis.
Change from baseline in CT quantitative (≥3.4) score at month 12 12 months CT quantitative scores range from 0 to no upper limits, with higher scores indicating more lung fibrosis.
Rate of decline in FVC (ml) over 24 months Up to 24 months Change from baseline in dyspnea using University of California San Diego Shortness of Breath Questionnaire at month 18 18 months Scores range from 0 to 120, with higher scores indicating greater breathlessness.
Change from baseline in dyspnea using St. George's Respiratory Questionnaire impact score at month 18 18 months The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.
Change from baseline in 6-min walk distance at month 6 6 months Change from baseline in 6-min walk distance at month 18 18 months Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 18 18 months The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.
Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 24 24 months The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.
Change from baseline in dyspnea using St. George's Respiratory Questionnaire impact score at month 24 24 months The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.
Change from baseline in 6-min walk distance at month 24 24 months Rate of decline in DLCO (mmol/min/kpa) over 24 months Up to 24 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
University of Arizona
🇺🇸Tucson, Arizona, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of California Davis
🇺🇸Sacramento, California, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States