The Clinical Course of Interstitial Pneumonia With Autoimmune Features
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|ClinicalTrials.gov Identifier: NCT03950583|
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : October 3, 2019
Interstitial pneumonia with autoimmune features (IPAF) is a chronic interstitial lung disease (ILD) with some laboratoristic and/or clinical features of autoimmune disease, but without meeting criteria of connective tissue disease (CTD), and with no other causes of ILD. Despite recent efforts to standardize the diagnosis of IPAF, subjects with IPAF represent a very heterogenous group of patients, whose prognosis and clinical course are far from being clear. It also remains to be clarified what proportion of IPAF patients develop clear features of CTD over time.
The aim of this observational trial is to define the clinical course of patients newly diagnosed with IPAF by prospectively following them for a period of 3 years, at 6-month intervals. The primary outcome will be 3-year lung transplant-free survival. The secondary outcome will be the proportion of patients who develop clinical and laboratoristic features clearly meeting criteria for a diagnosis of CTD at 3 years from the time of diagnosis of IPAF. Predictors of survival will also be studied.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||The Clinical Course of Interstitial Pneumonia With Autoimmune Features: an Observational, Prospective Cohort Study|
|Actual Study Start Date :||June 12, 2019|
|Estimated Primary Completion Date :||June 11, 2024|
|Estimated Study Completion Date :||December 31, 2024|
- Survival [ Time Frame: 3 years ]Survival rate since the time of diagnosis
- Rate of development of autoimmune disease [ Time Frame: 3 years ]Incidence of a new diagnosis of autoimmune disease during the 3-year clinical course
- Clinical progression [ Time Frame: 3 years ]Time to either: decline of FVC >10% pred; decline of 6-min walk distance >50 m; hospitalization for respiratory causes; lung transplant assessment; or death.
- Acute exacerbation [ Time Frame: 3 years ]Incidence of acute exacerbations since the time of diagnosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950583
|Contact: Marco Mura, MD, PhDfirstname.lastname@example.org|
|Contact: Karishma Hosein, MScemail@example.com|
|London Health Science Centre||Recruiting|
|London, Ontario, Canada, N6A 5W9|
|Contact: Marco Mura, MD, PhD 5196676744 firstname.lastname@example.org|
|Contact: Karishma Hosein, MSc 5196676744 email@example.com|
|Principal Investigator: Marco Mura, MD, PhD|
|Principal Investigator: Pari Basharat, MD|
|Principal Investigator:||Marco Mura, MD, PhD||Lawson Research Institute|
|Principal Investigator:||Pari Basharat, MD||Lawson Research Institute|