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NCT Number: NCT04844359

A Prognostic Transcriptomic Signature for Chronic Hypersensitivity Pneumonitis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypersensitivity Pneumonitis Alveolitis, Extrinsic Allergic Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Interstitial Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arizona, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Up to 24 months

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

    Time frame: Up to 24 months

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

    Time frame: Up to 24 months

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

    Time frame: Up to 24 months

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

    Time frame: Up to 24 months

  6. Time to first adjudicated acute chronic hypersensitivity pneumonitis exacerbation

    Time frame: Up to 24 months

  7. Need for a new course of oral or intravenous steroids

    Time frame: Up to 24 months

  8. Time to death from any cause

    Time frame: Up to 24 months

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

    Time frame: 6 months

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

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

    Time frame: 12 months

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

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

    Time frame: 18 months

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

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

    Time frame: 24 months

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

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

    Time frame: 6 months

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

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

    Time frame: 12 months

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

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

    Time frame: 18 months

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

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

    Time frame: 24 months

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

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

    Time frame: 6 months

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

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

    Time frame: 12 months

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

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

    Time frame: 18 months

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

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

    Time frame: 24 months

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

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

    Time frame: 6 months

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

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

    Time frame: 12 months

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

    Time frame: 18 months

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

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

    Time frame: 24 months

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

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

    Time frame: 6 months

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

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

    Time frame: 12 months

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

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

    Time frame: 18 months

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

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

    Time frame: 24 months

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

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

    Time frame: 12 months

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

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

    Time frame: 24 months

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

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

    Time frame: 12 months

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

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

    Time frame: 24 months

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

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

    Time frame: 6 months

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

    Time frame: 12 months

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

    Time frame: 18 months

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

    Time frame: 24 months

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

    Time frame: Up to 24 months

  38. Rate of decline in FVC (ml) over 24 months

    Time frame: Up to 24 months

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

    Time frame: Up to 24 months

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

    Time frame: Up to 24 months

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Collaborators

  • Mayo Clinic
  • University of Arizona
  • University of California, Davis
  • University of Chicago
  • University of Texas Southwestern Medical Center
  • University of Utah

Registry information

Official study title

Development and Validation of a Prognostic Transcriptomic Signature for Chronic Hypersensitivity Pneumonitis

Acronym: PREDICT-HP

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2021
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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