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A Prognostic Transcriptomic Signature for Chronic Hypersensitivity Pneumonitis (PREDICT-HP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04844359
Recruitment Status : Recruiting
First Posted : April 14, 2021
Last Update Posted : June 1, 2021
Sponsor:
Collaborators:
University of California, Davis
Mayo Clinic
University of Chicago
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Evans Fernandez Perez, National Jewish Health

Study Description
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Brief Summary:
Up to 135 patients with hypersensitivity pneumonitis will be enrolled at 5 clinical centers across the United States. Patients will be followed for 24 months to determine if biomarkers in the blood can predict disease progression.

Condition or disease
Hypersensitivity Pneumonitis

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 135 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development and Validation of a Prognostic Transcriptomic Signature for Chronic Hypersensitivity Pneumonitis
Actual Study Start Date : January 6, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Pneumonia

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of men and women aged 18 to 80 years old with a diagnosis of chronic hypersensitivity pneumonitis.
Criteria

Inclusion Criteria:

  • Diagnosis of chronic hypersensitivity pneumonitis for at least 3 to 6 months.
  • Age 18 through 80 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04844359


Contacts
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Contact: Kaitlin Fier 303-270-2852 fierk@njhealth.org

Locations
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United States, California
University of California Davis Not yet recruiting
Sacramento, California, United States, 95817
Contact: Elena Foster    916-734-7155    eefoster@ucdavis.edu   
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Kaitlin Fier    303-270-2852    fierk@njhealth.org   
United States, Illinois
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Spring Maleckar    773-834-4053    smaleckar@medicine.bsd.uchicago.edu   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Shannon Daley    507-293-0637    daley.shannon@mayo.edu   
United States, Texas
University of Texas Southwestern Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Rhoda Annoh Gordon    214-645-7108    Rhoda.AnnohGordon@UTSouthwestern.edu   
Sponsors and Collaborators
National Jewish Health
University of California, Davis
Mayo Clinic
University of Chicago
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Evans Fernández, MD, MS National Jewish Health
More Information
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Responsible Party: Evans Fernandez Perez, Associate Professor, National Jewish Health
ClinicalTrials.gov Identifier: NCT04844359    
Other Study ID Numbers: R01HL148437 ( U.S. NIH Grant/Contract )
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Alveolitis, Extrinsic Allergic
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Infections
 Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Respiratory Hypersensitivity
Hypersensitivity, Immediate