NCT04844359

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jan 2021Jul 2026

Study Start

First participant enrolled

January 6, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

5.6 years

First QC Date

March 30, 2021

Last Update Submit

April 6, 2026

Conditions

Hypersensitivity Pneumonitis

Outcome Measures

Primary Outcomes (40)

  • 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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Arizona

Tucson, Arizona, 85719, United States

Location

University of California Davis

Sacramento, California, 95817, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Alveolitis, Extrinsic Allergic

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Evans Fernández, MD, MS

    National Jewish Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 14, 2021

Study Start

January 6, 2021

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

US(7)