Clinical trial NCT04844359: A Prognostic Transcriptomic Signature for Chronic Hypersensitivity Pneumonitis
Official title: Development and Validation of a Prognostic Transcriptomic Signature for Chronic Hypersensitivity Pneumonitis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypersensitivity Pneumonitis
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: University of California, Davis
name: Mayo Clinic
name: University of Chicago
name: University of Texas Southwestern Medical Center
name: University of Arizona
name: University of Utah
First posted: 2021-04-14
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to absolute FVC (percent predicted) decline ≥10 percent
timeFrame: Up to 24 months
measure: Time to absolute DLCO (percent predicted) decline ≥10 percent
timeFrame: Up to 24 months
measure: Time to relative FVC (percent predicted) decline ≥10 percent
timeFrame: Up to 24 months
measure: Time to relative DLCO (percent predicted) decline ≥10 percent
timeFrame: Up to 24 months
measure: Time to relative DLCO (percent predicted) decline ≥15 percent
timeFrame: Up to 24 months
measure: Time to first adjudicated acute chronic hypersensitivity pneumonitis exacerbation
timeFrame: Up to 24 months
measure: Need for a new course of oral or intravenous steroids
timeFrame: Up to 24 months
measure: Time to death from any cause
timeFrame: Up to 24 months
measure: Change from baseline in St. George's Respiratory Questionnaire total score at month 6
timeFrame: 6 months
measure: Change from baseline in St. George's Respiratory Questionnaire total score at month 12
timeFrame: 12 months
measure: Change from baseline in St. George's Respiratory Questionnaire total score at month 18
timeFrame: 18 months
measure: Change from baseline in St. George's Respiratory Questionnaire total score at month 24
timeFrame: 24 months
measure: Change from baseline in dyspnea using University of California San Diego Shortness of Breath Questionnaire at month 6
timeFrame: 6 months
measure: Change from baseline in dyspnea using University of California San Diego Shortness of Breath Questionnaire at month 12
timeFrame: 12 months
measure: Change from baseline in dyspnea using University of California San Diego Shortness of Breath Questionnaire at month 18
timeFrame: 18 months
measure: Change from baseline in dyspnea using University of California San Diego Shortness of Breath Questionnaire at month 24
timeFrame: 24 months
measure: Change from baseline in dyspnea using St. George's Respiratory Questionnaire symptoms score at month 6
timeFrame: 6 months
measure: Change from baseline in dyspnea using St. George's Respiratory Questionnaire symptoms score at month 12
timeFrame: 12 months
measure: Change from baseline in dyspnea using St. George's Respiratory Questionnaire symptoms score at month 18
timeFrame: 18 months
measure: Change from baseline in dyspnea using St. George's Respiratory Questionnaire symptoms score at month 24
timeFrame: 24 months
measure: Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 6
timeFrame: 6 months
measure: Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 12
timeFrame: 12 months
measure: Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 18
timeFrame: 18 months
measure: Change from baseline in dyspnea using St. George's Respiratory Questionnaire activity score at month 24
timeFrame: 24 months
measure: Change from baseline in dyspnea using St. George's Respiratory Questionnaire impact score at month 6
timeFrame: 6 months
measure: Change from baseline in dyspnea using St. George's Respiratory Questionnaire impact score at month 12
timeFrame: 12 months
measure: Change from baseline in dyspnea using St. George's Respiratory Questionnaire impact score at month 18
timeFrame: 18 months
measure: Change from baseline in dyspnea using St. George's Respiratory Questionnaire impact score at month 24
timeFrame: 24 months
measure: Change from baseline in CT visual (≥10 percent) score at month 12
timeFrame: 12 months
measure: Change from baseline in CT visual (≥10 percent) score at month 24
timeFrame: 24 months
measure: Change from baseline in CT quantitative (≥3.4) score at month 12
timeFrame: 12 months
measure: Change from baseline in CT quantitative (≥3.4) score at month 24
timeFrame: 24 months
measure: Change from baseline in 6-min walk distance at month 6
timeFrame: 6 months
measure: Change from baseline in 6-min walk distance at month 12
timeFrame: 12 months
measure: Change from baseline in 6-min walk distance at month 18
timeFrame: 18 months
measure: Change from baseline in 6-min walk distance at month 24
timeFrame: 24 months
measure: Rate of decline in FVC (percent predicted) over 24 months
timeFrame: Up to 24 months
measure: Rate of decline in FVC (ml) over 24 months
timeFrame: Up to 24 months
measure: Rate of decline in DLCO (percent predicted) over 24 months
timeFrame: Up to 24 months
measure: Rate of decline in DLCO (mmol/min/kpa) over 24 months
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: National Jewish Health
name: Evans Fernández, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: