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Clinical Characteristics of Interstitial Pneumonia With Autoimmune Features (IPAF) - a Multicenter Prospective Study

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: NCT03870828
Recruitment Status : Not yet recruiting
First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Adam Barczyk, Medical University of Silesia

Brief Summary:

Interstitial pneumonia with autoimmune features (IPAF) was defined in 2015 by the Working Group of the European Respiratory Society (ERS) and the American Thoracic Society (ATS) as interstitial pneumonia with some clinical and/or serological features suggesting presence of an underlying autoimmune disorder. However, ofiicial criteria for diagnosis of an autoimmune disease are not met.

Aims of the study:

  1. Determine the incindence of IPAF in comparison with interstitial lung diseases (ILDs) and classic autoimmune diseases (ADs) in polish pulmonological centers.
  2. Clinical, serological, functional and radiological and histopathological characteristics of IPAF patients.
  3. Analysis of diagnostic strategies towards specific IPAF subgroups.
  4. Characterictics of potencial diagnostic, predictive and prognostic features of IPAF.
  5. Prospective assessment of IPAF patients in the courseof 5 years in order to determine stability of the diagnosis and potential progression to other diseases, e.g. ADs.

Condition or disease Intervention/treatment
Interstitial Lung Disease Interstitial Pneumonia Interstitial Fibrosis Autoimmune Diseases Diagnostic Test: Bronchoalveolar lavage and taking bronchial mucosa samples Diagnostic Test: 6minute walk test Diagnostic Test: Arterial blood gas Procedure: Blood drawing

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Study Type : Observational
Estimated Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence, Clinical Characteristics and Evaluation of Prognostic and Diagnostic Markers of Interstitial Pneumonia With Autoimmune Features (IPAF) - a Multicenter Prospective Study
Estimated Study Start Date : March 18, 2019
Estimated Primary Completion Date : February 18, 2020
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort Intervention/treatment
Study group IPAF

Patients with IPAF which is defined according to the Work Group of the European Respiratory Society/American Thoracic Society.

The interventions to be administered include:bronchoalveolar lavage and taking bronchial mucosa samples lung function tests,6 minute walk test, use of cough and dyspnea scales, transthoracic echocardiography, blood testing, arterial blood gas and pulse oximetry

Diagnostic Test: Bronchoalveolar lavage and taking bronchial mucosa samples

Regional anesthesia and sedation with use of lidocaine and midazolam will be performed, according to anesthesia protocols applied in respective endoscopy units. Intravenous cannula will be inserted prior to BF. During endoscopy, the patient will be monitored according to safety protocols applied in respective endoscopy units.

Bronchoalveolar lavage will be performed in the bronchus from the middle robe of right lung or the lingula of left lung (B4, B5). Localization will be chosen based on HRCT results and will be recorded in patient's medical history. Sterile solution of 0, 9% NaCl will be instilled. 200 ml fluid will be applied with a syringe in portions of 25 ml or 50 ml. It is recommended that minimum 60 % of the lavage fluid is retrieved.


Diagnostic Test: 6minute walk test
a submaximal exercise test which entails measurement of distance walked over a span of 6 minutes. Blood pressure, pulse oximetry are measured directly before and after the test. The participant is also periodically asked about their dyspnea sensation
Other Name: 6MWT

Diagnostic Test: Arterial blood gas
If SpO2 is measured to be < 92%, an artery (radial or femoral) is punctured in order to take a sample of arterial blood. Then, the artery is compressed in order to prevent bleeding/ hematoma.
Other Name: ABG

Procedure: Blood drawing
A vein will be punctured in order to take a blood sample for further tests

Control group CTD-ILD
Patients with connective tissue disease associated intestitial lung disease: rheumatoid arthritis - RA, systemic sclerosis - SSc, polymyositis - PM, dermatomyositis - DM, (anti-synthetase syndrome - AS, Sjögren's syndrome - SjS, mixed connective tissue disease - MCTD ,systemic lupus erythematosus - SLE, diagnosed according to diagnostic criteria issued by European League Against Rheumatism (EULAR) and/or American College of Rheumatology (ACR)
Diagnostic Test: Bronchoalveolar lavage and taking bronchial mucosa samples

Regional anesthesia and sedation with use of lidocaine and midazolam will be performed, according to anesthesia protocols applied in respective endoscopy units. Intravenous cannula will be inserted prior to BF. During endoscopy, the patient will be monitored according to safety protocols applied in respective endoscopy units.

Bronchoalveolar lavage will be performed in the bronchus from the middle robe of right lung or the lingula of left lung (B4, B5). Localization will be chosen based on HRCT results and will be recorded in patient's medical history. Sterile solution of 0, 9% NaCl will be instilled. 200 ml fluid will be applied with a syringe in portions of 25 ml or 50 ml. It is recommended that minimum 60 % of the lavage fluid is retrieved.


Diagnostic Test: 6minute walk test
a submaximal exercise test which entails measurement of distance walked over a span of 6 minutes. Blood pressure, pulse oximetry are measured directly before and after the test. The participant is also periodically asked about their dyspnea sensation
Other Name: 6MWT

Diagnostic Test: Arterial blood gas
If SpO2 is measured to be < 92%, an artery (radial or femoral) is punctured in order to take a sample of arterial blood. Then, the artery is compressed in order to prevent bleeding/ hematoma.
Other Name: ABG

Procedure: Blood drawing
A vein will be punctured in order to take a blood sample for further tests

Control group ILD
Idiopathic interstitial pneumonia group: idiopathic pulmonary fibrosis - IPF, nonspecific interstitial pneumonia - NSIP, cryptogenic organizing pneumonia - COP, acute interstitial pneumonia - AIP; respiratory bronchiolitis associated interstitial lung disease - RB-ILD, desquamative interstitial pneumonia - DIP, lymphocytic interstitial pneumonia - LIP).
Diagnostic Test: Bronchoalveolar lavage and taking bronchial mucosa samples

Regional anesthesia and sedation with use of lidocaine and midazolam will be performed, according to anesthesia protocols applied in respective endoscopy units. Intravenous cannula will be inserted prior to BF. During endoscopy, the patient will be monitored according to safety protocols applied in respective endoscopy units.

Bronchoalveolar lavage will be performed in the bronchus from the middle robe of right lung or the lingula of left lung (B4, B5). Localization will be chosen based on HRCT results and will be recorded in patient's medical history. Sterile solution of 0, 9% NaCl will be instilled. 200 ml fluid will be applied with a syringe in portions of 25 ml or 50 ml. It is recommended that minimum 60 % of the lavage fluid is retrieved.


Diagnostic Test: 6minute walk test
a submaximal exercise test which entails measurement of distance walked over a span of 6 minutes. Blood pressure, pulse oximetry are measured directly before and after the test. The participant is also periodically asked about their dyspnea sensation
Other Name: 6MWT

Diagnostic Test: Arterial blood gas
If SpO2 is measured to be < 92%, an artery (radial or femoral) is punctured in order to take a sample of arterial blood. Then, the artery is compressed in order to prevent bleeding/ hematoma.
Other Name: ABG

Procedure: Blood drawing
A vein will be punctured in order to take a blood sample for further tests




Primary Outcome Measures :
  1. Identification of IPAF diagnostic markers [ Time Frame: 10.2019-10.2020 ]
    It is still unclear whether there are diagnostic markers specific for IPAF or whether there is a significant difference in concentration of fibrosis biomarkers in IPAF, CTD-ILD and ILD groups. Both blood and BAL biomarkers will be taken under consideration, they include chemokine C-C motif ligand 18 (CXCL18), Surfactant Protein A- (SP-A), Surfactant Protein D (SP-D), Krebs von den Lungen-6 protein (KL-6) and chitotrisidase 1 (CHIT1).


Biospecimen Retention:   Samples With DNA

The following biospecimens will be collected:

  • blood (whole venous blood and serum)
  • bronchoalveolar lavage fluid
  • samples of bronchial mucosa


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

The study population will be recruited from patients hospitalized in pneumonology wards in clinical centers participating in the study. They will be divided into 3 subgroups:

Study group - IPAF. 2. Control groups:

  1. Connective tissue disease associated interstitial lung disease (CTD-ILD) patients:
  2. Idiopathic interstitial pneumonia group
Criteria

Inclusion Criteria:

  • written informed consent to participate in the study
  • diagnosis of one of interstitial lung diseases/autoimmune diseases as described below

Exclusion Criteria:

  • age < 18 years
  • withdrawal od consent
  • pregnancy
  • lactation
  • infectious disease 4 weeks prior

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): NCT03870828


Contacts
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Contact: Adam Barczyk, Professor +48324796101 adagne@icloud.com
Contact: Patrycja Rzepka-Wrona, MD +48324796101 patrycja.rzepka2@gmail.com

Locations
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Italy
Universita' degli Studi di Messina
Messina, Province Of Messina, Italy, 98122
Contact: Gaetano Caramori, Professor    390906761    pneumologia@polime.it   
Principal Investigator: Gaetano Caramori, Professor         
Poland
Katedra i Klinika Pneumonologii, Onkologii i Alergologii Uniwersytetu Medycznego w Lublinie
Lublin, Lubelskie, Poland, 20-400
Contact: Janusz Milanowski, Professor    48817244431    janusz.milanowski@umlub.pl   
Principal Investigator: Janusz Milanowski, Professor         
Sub-Investigator: Barbara Mackiewicz, Ph.D.         
II Katedra Chorob Wewnetrznych Uniwersytetu Jagiellonskiego Collegium Medicum im. prof. A. Szczeklika Szpitala Uniwersyteckiego
Kraków, Malopolskie, Poland, 31-066
Contact: Krzysztof Sladek, Professor    48124305147    krzysztof.sladek@uj.edu.pl   
Principal Investigator: Krzysztof Sladek, Professor         
Klinika Alergologii Gdanskiego Uniwersytetu Medycznego
Gdańsk, Pomorskie, Poland, 80-211
Contact: Ewa Jassem, Professor    48583492625    ejassem@gumed.edu.pl   
Principal Investigator: Ewa Jassem, Professor         
Katedra i Klinika Pneumonologii Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, Slaskie, Poland
Contact: Adam Barczyk, Professor    48324796101    adagne@icloud.com   
Principal Investigator: Adam Barczyk, Professor         
Sub-Investigator: Patrycja Rzepka-Wrona, MD         
Sub-Investigator: Szymon Skoczynski, PhD         
Sub-Investigator: Ewa Sozanska, PhD         
Samodzielny Publiczny Szpital Kliniczny nr 1 im. prof. St. Szyszko Sląskiego Uniwersytetu Medycznego w Katowicach
Zabrze, Slask, Poland, 41-800
Contact: Dariusz Ziora, Professor    48323732235    zioradar@wp.pl   
Principal Investigator: Dariusz Ziora, Professor         
Katedra i Klinika Pulmonologii, Alergologii i Onkologii Pulmonologicznej Uniwersytetu Medycznego im. K. Marcinkowskiego w Poznaniu
Poznań, Wielkopolskie, Poland, 60-514
Contact: Halina Batura-Gabryel, Professor    48618417061    halinagabryel@wp.pl   
Principal Investigator: Halina Batura-Gabryel, Professor         
Sponsors and Collaborators
Medical University of Silesia
Investigators
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Study Chair: Szymon Skoczynski, MD, PhD Slaski Uniwersytet Medyczny
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Responsible Party: Adam Barczyk, Professor, Ph.D., M.D., Medical University of Silesia
ClinicalTrials.gov Identifier: NCT03870828    
Other Study ID Numbers: SilesianMU1
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 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 Adam Barczyk, Medical University of Silesia:
IPAF
CTD-ILD
ILD
diagnostic markers
progression markers
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Lung Diseases, Interstitial
Autoimmune Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Immune System Diseases