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Registry for Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease

Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) and Interstitial Lung Disease Prospective Outcomes (IPF-PRO/ILD-PRO) Registry

Duke University · NCT01915511

This study is collecting information from people with idiopathic pulmonary fibrosis and other lung diseases to better understand their experiences and health over several years.

Quick facts

Study typeObservational
Enrollment3000 (estimated)
Ages21 Years and up
SexAll
SponsorDuke University (other)
Locations44 sites (Birmingham, Alabama and 43 other locations)
Trial IDNCT01915511 on ClinicalTrials.gov

What this trial studies

The Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry aims to collect comprehensive data on patients diagnosed with idiopathic pulmonary fibrosis (IPF) and other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. This observational registry will enroll participants over multiple phases, gathering information on their natural history, healthcare interactions, and quality of life through participant-reported questionnaires. The study will involve approximately 50 experienced sites across the United States and aims to enroll a total of 2000 patients with IPF and 1000 patients with other chronic fibrosing ILDs. Data collection will span 3 to 5 years, depending on the cohort.

Who should consider this trial

Good fit: Ideal candidates include adults aged 21 and older with a new diagnosis of idiopathic pulmonary fibrosis or other chronic fibrosing ILDs with a progressive phenotype.

Not a fit: Patients with stable chronic fibrosing ILDs that do not exhibit a progressive phenotype may not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could enhance understanding of the progression and treatment of idiopathic pulmonary fibrosis and related diseases, ultimately improving patient care.

How similar studies have performed: Other studies focusing on registries for chronic lung diseases have shown promise in understanding disease progression and treatment outcomes, indicating that this approach is supported by previous successes.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Birmingham, Alabama and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Idiopathic pulmonary fibrosis, Pulmonary fibrosis, IPF, Registry, 1199.174, Interstitial Lung Disease, ILD

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.