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

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

Up to 135 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.

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Estimated): 135

Contacts and Locations

• Study Contact: Name: Kaitlin Fier; Phone Number: 303-270-2852; Email: fierk@njhealth.org

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Recruiting
      • University of Arizona
      • Contact: Heidi Erickson; Phone Number: 520-626-5287; Email: herickso@arizona.edu
      • Principal Investigator: Sachin Chaudhary, MD
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California Davis
      • Principal Investigator: Namita Sood, MD
      • Contact: Elena Foster; Phone Number: 916-734-7155; Email: eefoster@ucdavis.edu
  • Colorado
    • Denver, Colorado, United States, 80206
      • Recruiting
      • National Jewish Health
      • Contact: Kaitlin Fier; Phone Number: 303-270-2852; Email: fierk@njhealth.org
      • Principal Investigator: Evans Fernandez-Perez, MD
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Contact: Spring Maleckar; Phone Number: 773-834-4053; Email: smaleckar@medicine.bsd.uchicago.edu
      • Principal Investigator: Ayodeji Adegunsoye, MD
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Shannon Daley; Phone Number: 507-293-0637; Email: daley.shannon@mayo.edu
      • Principal Investigator: Teng Moua, MD
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern
      • Contact: Rhoda Annoh Gordon; Phone Number: 214-645-7108; Email: Rhoda.AnnohGordon@UTSouthwestern.edu
      • Principal Investigator: Traci Adams, MD
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • Recruiting
      • University of Utah
      • Contact: Chloe Kirkpatrick; Email: chloe.kirkpatrick@hsc.utah.edu
      • Principal Investigator: Mary Beth Scholand, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of men and women aged 18 to 85 years old with a diagnosis of chronic hypersensitivity pneumonitis.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: National Jewish Health
• Collaborators: Mayo Clinic; University of Chicago; University of California, Davis; University of Texas Southwestern Medical Center; University of Utah; University of Arizona
• Investigators: Principal Investigator: Evans Fernández, MD, MS, National Jewish Health

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: April 9, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Respiratory Hypersensitivity; Lung Diseases, Interstitial; Hypersensitivity; Pneumonia; Alveolitis, Extrinsic Allergic
• Other Study ID Numbers: R01HL148437 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No