Status:
RECRUITING
Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry
Lead Sponsor:
Duke University
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
Eligibility:
All Genders
21+ years
Brief Summary
The Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry started recruiting in 2014 with the objective of studying Idiopathic Pulmonary Fibrosis. In 2018, the registry expanded to inc...
Detailed Description
This registry originally enrolled a total of 1002 participants newly diagnosed with IPF and continues to enroll patients with other chronic fibrosing ILDs with newly identified progressive phenotype t...
Eligibility Criteria
Inclusion
- Willing and able to provide informed consent
- Established a new diagnosis (within 12 months) of IPF by the enrolling center.
- Age 21 years or older, or
- Diagnosis of a non-IPF ILD of any duration, including, but not limited to Idiopathic Non-Specific Interstitial Pneumonia (iNSIP), Unclassifiable Idiopathic Interstitial Pneumonias (IIPs), Interstitial Pneumonia with Autoimmune Features (IPAF), Autoimmune ILDs such as Rheumatoid Arthritis (RA-ILD) and Systemic Sclerosis (SSc-ILD), Chronic Hypersensitivity Pneumonitis (HP), Sarcoidosis or Exposure-related ILDs such as asbestosis with progressive phenotype during the last 24 months by the enrolling center that meets the following criteria:
- Chronic fibrosing ILD as defined by reticular abnormality with traction bronchiectasis with or without honeycombing confirmed by chest HRCT scan and/or lung biopsy.
- Progressive phenotype as defined by fulfilling at least one of the criteria below of fibrotic changes (progression set point) within the last 24 months regardless of treatment considered appropriate in individual ILDs (8):
- decline in FVC % predicted (% pred) based on ≥10% relative decline
- decline in FVC % pred based on ≥5 - \<10% relative decline in FVC combined with worsening of respiratory symptoms as assessed by the site investigator
- decline in FVC % pred based on ≥5 - \<10% relative decline in FVC combined with increasing extent of fibrotic changes on chest imaging (HRCT scan) as assessed by the site investigator
- decline in DLCO % pred based on≥ 10% relative decline
- worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging (HRCT scan) as assessed by the site investigator independent of FVC change.
- The relative decline for FVC % predicted is calculated using the formula:
- Relative Decline= (FVC % Pred (Reference)-FVC % Pred (Screening))/(FVC % Pred (Reference))×100%, where FVC % Pred (Reference) is the greatest measurement of FVC % predicted in the 24 months prior to screening and FVC % Pred (Screening) is the measurement of FVC % predicted at screening.
- The relative decline for DLCO % predicted is calculated using the formula:
- Relative Decline= (DLCO % Pred (Reference)-DLCO % Pred (Screening))/(DLCO % Pred (Reference))×100%, Where DLCO % Pred (Reference) is the greatest measurement of DLCO % Pred in the 24 months prior to screening and DLCO % Pred (Screening) is the measurement of DLCO % Pred at screening
Exclusion
- Malignancy, treated or untreated, other than skin or early -stage prostate cancer, within the past 5 years
- Currently listed for lung transplantation at the time of enrollment
- Currently enrolled in an interventional clinical trial at the time of enrollment in this registry
- For the additional IPF cohort of 1000 individuals, previous enrollment in this registry.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2031
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT01915511
Start Date
June 1 2014
End Date
January 1 2031
Last Update
October 14 2025
Active Locations (40)
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1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
2
University of California - Los Angeles
Los Angeles, California, United States, 90024
3
University of Southern California
Los Angeles, California, United States, 90033
4
Stanford University
Stanford, California, United States, 94305