Hypersensitivity PneumonitisPREDICT-HPNCT04844359
A Prognostic Transcriptomic Signature for Chronic Hypersensitivity Pneumonitis
An observational study of Hypersensitivity Pneumonitis, run by National Jewish Health at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypersensitivity Pneumonitis
- How many people
- 137 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 Jan 2021to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of men and women aged 18 to 85 years old with a diagnosis of chronic hypersensitivity pneumonitis.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Chicago
Chicago, Illinois, 60637
University of Texas Southwestern
Dallas, Texas, 75390
National Jewish Health
Denver, Colorado, 80206
Mayo Clinic
Rochester, Minnesota, 55905
University of California Davis
Sacramento, California, 95817
University of Utah
Salt Lake City, Utah, 84108
University of Arizona
Tucson, Arizona, 85719
About this study
Official title: Development and Validation of 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.
Read the 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.
- Conditions
- Hypersensitivity Pneumonitis
- Medical subject headings
- Alveolitis, Extrinsic Allergic
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to absolute FVC (percent predicted) decline ≥10 percent
Measured: Up to 24 months
Time to absolute DLCO (percent predicted) decline ≥10 percent
Measured: Up to 24 months
Time to relative FVC (percent predicted) decline ≥10 percent
Measured: Up to 24 months
Time to relative DLCO (percent predicted) decline ≥10 percent
Measured: Up to 24 months
Time to relative DLCO (percent predicted) decline ≥15 percent
Measured: Up to 24 months
Time to first adjudicated acute chronic hypersensitivity pneumonitis exacerbation
Measured: Up to 24 months
Need for a new course of oral or intravenous steroids
Measured: Up to 24 months
Time to death from any cause
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 12
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Change from baseline in 6-min walk distance at month 6
Measured: 6 months
Change from baseline in 6-min walk distance at month 12
Measured: 12 months
Change from baseline in 6-min walk distance at month 18
Measured: 18 months
Change from baseline in 6-min walk distance at month 24
Measured: 24 months
Rate of decline in FVC (percent predicted) over 24 months
Measured: Up to 24 months
Rate of decline in FVC (ml) over 24 months
Measured: Up to 24 months
Rate of decline in DLCO (percent predicted) over 24 months
Measured: Up to 24 months
Rate of decline in DLCO (mmol/min/kpa) over 24 months
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start6 Jan 2021
- Primary completion30 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypersensitivity PneumonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, Mayo Clinic, University of Chicago, University of Texas Southwestern Medical Center, University of Arizona, University of Utah
- Responsible party
- Principal investigator, Evans Fernandez Perez, National Jewish Health
- Investigators
- Evans Fernández, MD, MS, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844359
- Sponsor's protocol ID
- R01HL148437
- Acronym
- PREDICT-HP
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2021
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Prognostic Transcriptomic Signature for Chronic Hypersensitivity Pneumonitis
- ClinicalTrials.gov ID
- NCT04844359
- Acronym / sponsor ID
- PREDICT-HP / R01HL148437
- Conditions
- Hypersensitivity Pneumonitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 137 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- University of California, Davis, Mayo Clinic, University of Chicago, University of Texas Southwestern Medical Center, University of Arizona, University of Utah
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of men and women aged 18 to 85 years old with a diagnosis of chronic hypersensitivity pneumonitis.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to absolute FVC (percent predicted) decline ≥10 percent
Time frame: Up to 24 months
Time to absolute DLCO (percent predicted) decline ≥10 percent
Time frame: Up to 24 months
Time to relative FVC (percent predicted) decline ≥10 percent
Time frame: Up to 24 months
Time to relative DLCO (percent predicted) decline ≥10 percent
Time frame: Up to 24 months
Time to relative DLCO (percent predicted) decline ≥15 percent
Time frame: Up to 24 months
Time to first adjudicated acute chronic hypersensitivity pneumonitis exacerbation
Time frame: Up to 24 months
Need for a new course of oral or intravenous steroids
Time frame: Up to 24 months
Time to death from any cause
Time frame: Up to 24 months
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 12
Time frame: 12 months
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Change from baseline in 6-min walk distance at month 6
Time frame: 6 months
Change from baseline in 6-min walk distance at month 12
Time frame: 12 months
Change from baseline in 6-min walk distance at month 18
Time frame: 18 months
Change from baseline in 6-min walk distance at month 24
Time frame: 24 months
Rate of decline in FVC (percent predicted) over 24 months
Time frame: Up to 24 months
Rate of decline in FVC (ml) over 24 months
Time frame: Up to 24 months
Rate of decline in DLCO (percent predicted) over 24 months
Time frame: Up to 24 months
Rate of decline in DLCO (mmol/min/kpa) over 24 months
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evans Fernández, MD, MS principal investigator
National Jewish Health
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypersensitivity Pneumonitis, run by National Jewish Health at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to absolute FVC (percent predicted) decline ≥10 percent (time frame: Up to 24 months). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.