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.
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Time to absolute FVC (percent predicted) decline ≥10 percent
Timeframe: Up to 24 months
Time to absolute DLCO (percent predicted) decline ≥10 percent
Timeframe: Up to 24 months
Time to relative FVC (percent predicted) decline ≥10 percent
Timeframe: Up to 24 months
Time to relative DLCO (percent predicted) decline ≥10 percent
Timeframe: Up to 24 months
Time to relative DLCO (percent predicted) decline ≥15 percent
Timeframe: Up to 24 months
Time to first adjudicated acute chronic hypersensitivity pneumonitis exacerbation
Timeframe: Up to 24 months
Need for a new course of oral or intravenous steroids
Timeframe: Up to 24 months
Time to death from any cause
Timeframe: Up to 24 months
Change from baseline in St. George's Respiratory Questionnaire total score at month 6
Timeframe: 6 months
Change from baseline in St. George's Respiratory Questionnaire total score at month 12
Timeframe: 12 months
Change from baseline in St. George's Respiratory Questionnaire total score at month 18
Timeframe: 18 months
Change from baseline in St. George's Respiratory Questionnaire total score at month 24
Timeframe: 24 months
Change from baseline in dyspnea using University of California San Diego Shortness of Breath Questionnaire at month 6
Timeframe: 6 months
Change from baseline in dyspnea using University of California San Diego Shortness of Breath Questionnaire at month 12
Timeframe: 12 months
Change from baseline in dyspnea using University of California San Diego Shortness of Breath Questionnaire at month 18
Timeframe: 18 months
Change from baseline in dyspnea using University of California San Diego Shortness of Breath Questionnaire at month 24
Timeframe: 24 months
Change from baseline in dyspnea using St. George's Respiratory Questionnaire symptoms score at month 6
Timeframe: 6 months
Change from baseline in dyspnea using St. George's Respiratory Questionnaire symptoms score at month 12
Timeframe: 12 months
Change from baseline in dyspnea using St. George's Respiratory Questionnaire symptoms score at month 18
Timeframe: 18 months
Change from baseline in dyspnea using St. George's Respiratory Questionnaire symptoms score at month 24
Timeframe: 24 months
Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 6
Timeframe: 6 months
Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 12
Timeframe: 12 months
Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 18
Timeframe: 18 months
Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 24
Timeframe: 24 months
Change from baseline in dyspnea using St. George's Respiratory Questionnaire impact score at month 6
Timeframe: 6 months
Change from baseline in dyspnea using St. George's Respiratory Questionnaire impact score at month 12
Timeframe: 12 months
Change from baseline in dyspnea using St. George's Respiratory Questionnaire impact score at month 18
Timeframe: 18 months
Change from baseline in dyspnea using St. George's Respiratory Questionnaire impact score at month 24
Timeframe: 24 months
Change from baseline in CT visual (≥10 percent) score at month 12
Timeframe: 12 months
Change from baseline in CT visual (≥10 percent) score at month 24
Timeframe: 24 months
Change from baseline in CT quantitative (≥3.4) score at month 12
Timeframe: 12 months
Change from baseline in CT quantitative (≥3.4) score at month 24
Timeframe: 24 months
Change from baseline in 6-min walk distance at month 6
Timeframe: 6 months
Change from baseline in 6-min walk distance at month 12
Timeframe: 12 months
Change from baseline in 6-min walk distance at month 18
Timeframe: 18 months
Change from baseline in 6-min walk distance at month 24
Timeframe: 24 months
Rate of decline in FVC (percent predicted) over 24 months
Timeframe: Up to 24 months
Rate of decline in FVC (ml) over 24 months
Timeframe: Up to 24 months
Rate of decline in DLCO (percent predicted) over 24 months
Timeframe: Up to 24 months
Rate of decline in DLCO (mmol/min/kpa) over 24 months
Timeframe: Up to 24 months