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| Name | Class |
|---|---|
| University of California, Davis | OTHER |
| Mayo Clinic | OTHER |
| University of Chicago | OTHER |
| University of Texas Southwestern Medical Center |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Time to absolute FVC (percent predicted) decline ≥10 percent | Up to 24 months | |
| Time to absolute DLCO (percent predicted) decline ≥10 percent | Up to 24 months | |
| Time to relative FVC (percent predicted) decline ≥10 percent | Up to 24 months | |
| Time to relative DLCO (percent predicted) decline ≥10 percent | Up to 24 months | |
| Time to relative DLCO (percent predicted) decline ≥15 percent | Up to 24 months | |
| Time to first adjudicated acute chronic hypersensitivity pneumonitis exacerbation | Up to 24 months | |
| Need for a new course of oral or intravenous steroids | 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 6 | The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life. | 6 months |
| Change from baseline in St. George's Respiratory Questionnaire total score at month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of men and women aged 18 to 85 years old with a diagnosis of chronic hypersensitivity pneumonitis.
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| Name | Affiliation | Role |
|---|---|---|
| Evans Fernández, MD, MS | National Jewish Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85719 | United States | ||
| University of California Davis |
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| ID | Term |
|---|---|
| D000542 | Alveolitis, Extrinsic Allergic |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| OTHER |
| University of Arizona | OTHER |
| University of Utah | OTHER |
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The total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life.
| 12 months |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 6 months |
| Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 12 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 24 months |
| Change from baseline in 6-min walk distance at month 6 | 6 months |
| Change from baseline in 6-min walk distance at month 12 | 12 months |
| Change from baseline in 6-min walk distance at month 18 | 18 months |
| Change from baseline in 6-min walk distance at month 24 | 24 months |
| Rate of decline in FVC (percent predicted) over 24 months | Up to 24 months |
| Rate of decline in FVC (ml) over 24 months | Up to 24 months |
| Rate of decline in DLCO (percent predicted) over 24 months | Up to 24 months |
| Rate of decline in DLCO (mmol/min/kpa) over 24 months | Up to 24 months |
| Sacramento |
| California |
| 95817 |
| United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |