A Prognostic Transcriptomic Signature for Chronic Hypersensitivity Pneumonitis

Hypersensitivity Pneumonitis Clinical Trial

— PREDICT-HP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04844359
• Other study ID #: R01HL148437
• Status: Recruiting
• Start date: January 6, 2021
• Est. completion date: January 2026

Study information

• Verified date: March 2024
• Source: National Jewish Health
• Contact: Kaitlin Fier
• Phone: 303-270-2852
• Email: fierk[@]njhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolitis, Extrinsic Allergic
• Hypersensitivity
• Hypersensitivity Pneumonitis
• Pneumonia

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	University of Texas Southwestern	Dallas	Texas
United States	National Jewish Health	Denver	Colorado
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California Davis	Sacramento	California
United States	University of Utah	Salt Lake City	Utah
United States	University of Arizona	Tucson	Arizona

Sponsors (7)

Lead Sponsor	Collaborator
National Jewish Health	Mayo Clinic, University of Arizona, University of California, Davis, University of Chicago, University of Texas Southwestern Medical Center, University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to absolute FVC (percent predicted) decline =10 percent		Up to 24 months
Primary	Time to absolute DLCO (percent predicted) decline =10 percent		Up to 24 months
Primary	Time to relative FVC (percent predicted) decline =10 percent		Up to 24 months
Primary	Time to relative DLCO (percent predicted) decline =10 percent		Up to 24 months
Primary	Time to relative DLCO (percent predicted) decline =15 percent		Up to 24 months
Primary	Time to first adjudicated acute chronic hypersensitivity pneumonitis exacerbation		Up to 24 months
Primary	Need for a new course of oral or intravenous steroids		Up to 24 months
Primary	Time to death from any cause		Up to 24 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 12		12 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change from baseline in 6-min walk distance at month 6		6 months
Primary	Change from baseline in 6-min walk distance at month 12		12 months
Primary	Change from baseline in 6-min walk distance at month 18		18 months
Primary	Change from baseline in 6-min walk distance at month 24		24 months
Primary	Rate of decline in FVC (percent predicted) over 24 months		Up to 24 months
Primary	Rate of decline in FVC (ml) over 24 months		Up to 24 months
Primary	Rate of decline in DLCO (percent predicted) over 24 months		Up to 24 months
Primary	Rate of decline in DLCO (mmol/min/kpa) over 24 months		Up to 24 months