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The Clinical Course of Interstitial Pneumonia With Autoimmune Features

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03950583
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief Summary:

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
Interstitial Pneumonia

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia




Primary Outcome Measures :
  1. Survival [ Time Frame: 3 years ]
    Survival rate since the time of diagnosis


Secondary Outcome Measures :
  1. Rate of development of autoimmune disease [ Time Frame: 3 years ]
    Incidence of a new diagnosis of autoimmune disease during the 3-year clinical course

  2. 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.

  3. Acute exacerbation [ Time Frame: 3 years ]
    Incidence of acute exacerbations since the time of diagnosis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a new diagnosis of interstitial pneumonia with autoimmune features, according to ERS/ATS A,B,C criteria
Criteria

Inclusion Criteria:

  • new diagnosis of IPAF based on the A,B,C) ERS/ATS criteria (Eur Respir J 2015;46:976-87)

Exclusion Criteria:

  • Interstitial lung disease other than IPAF
  • Not a new diagnosis of IPAF

Information from the National Library of Medicine

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


Contacts
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Contact: Marco Mura, MD, PhD +1-5196676744 marco.mura@lhsc.on.ca
Contact: Karishma Hosein, MSc 5196676744 karishma.hosein@lhsc.on.ca

Locations
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Canada, Ontario
London Health Science Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Marco Mura, MD, PhD    5196676744    marco.mura@lhsc.on.ca   
Contact: Karishma Hosein, MSc    5196676744    karishma.hosein@lhsc.on.ca   
Principal Investigator: Marco Mura, MD, PhD         
Principal Investigator: Pari Basharat, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Marco Mura, MD, PhD Lawson Research Institute
Principal Investigator: Pari Basharat, MD Lawson Research Institute
Publications of Results:

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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03950583    
Other Study ID Numbers: 6476
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lawson Health Research Institute:
interstitial lung disease
interstitial pneumonia
connective tissue disease
clinical course
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections