Registry for Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama - Birmingham
  Birmingham, Alabama, United States Recruiting
• University of Arizona
  Tucson, Arizona, United States Recruiting
• University of California - Los Angeles
  Los Angeles, California, United States Recruiting
• University of Southern California
  Los Angeles, California, United States Recruiting
• Stanford University
  Stanford, California, United States Recruiting
• University of Colorado
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Scott Palmer, MD — Duke Clinical Research Institute, Duke University
• Study coordinator: Rosalia Blanco
• Email: rosalia.blanco@duke.edu
• Phone: 919-660-0890

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.