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Investigating Idiopathic Pulmonary Fibrosis in Greece (INDULGE IPF) (INDULGEIPF)

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ClinicalTrials.gov Identifier: NCT03074149
Recruitment Status : Recruiting
First Posted : March 8, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To gain further insight on the characteristics, management, disease progression and the outcomes of patients with IPF, as diagnosed and treated under real-world, clinical practice conditions in Greece. More specifically, this registry will be used to: Provide a comprehensive clinical picture of IPF, Track access to health care and cost of caring for IPF patients over time, Examine the implementation of treatment guidelines used on patients diagnosed with IPF, according to the existing diagnosis guidelines, Characterization of patients on different treatments. To provide information regarding survival and mortality causes, IPF exacerbations as well as IPF patient co-morbidities including myocardial infarction, CNS infarction, other arterial thromboembolic events, deep vein thrombosis, hemorrhage, gastrointestinal perforation and pulmonary hypertension. Data regarding IPF patient hospitalization will be collected and evaluated with regards to potential respiratory causes, and there will be documentation of treatment patterns and economic aspects. Patients will be followed up for 2 years and information regarding IPF treatment changes since the last visit will be collected.

Condition or disease
Idiopathic Pulmonary Fibrosis

Detailed Description:

Purpose: To gain further knowledge on the characteristics, management, progression and outcomes of patients with IPF as treated under real-world, clinical practice conditions in Greece

Study Design:

National, multi-center, observational disease registry based on new data from a significant sample size of IPF patients in Greece. Patients will be followed up for 2 years and information will be collected during this time period. This is a non-interventional study and primary data collected during study visits will be used


Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Investigating Idiopathic Pulmonary Fibrosis in Greece
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021


Group/Cohort
Idiopathic Pulmonary Disease patients
IPF patients/ only one group



Primary Outcome Measures :
  1. comprehensive clinical picture for IPF [ Time Frame: 2 years ]
  2. access to health care and cost of caring for IPF patients over time [ Time Frame: 2 years ]
  3. implementation of treatment guidelines, used on patients diagnosed with IPF, according to the existing diagnosis guidelines [ Time Frame: 2 years ]
  4. Characterization of patients on different treatments [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. drugs used for IPF [ Time Frame: 2 years ]
    Steroids Immunomodulators (azathioprine, cyclophosphamide, cyclosporine A, mycophenolate mofetil etc) N-Acetylcysteine Pirfenidone Nintedanib Anticoagulants Vit-K antagonist Heparin Antiplatelet therapy (if yes it will be specified if high dose antiplatelet therapy) Aspirin (if yes it will be specified if used as antiplatelet) GERD medication PDE-5 inhibitor (sildenafil, tadalafil) Endothelin receptor antagonist (bosentan, ambrisentan, macitentan) Long term oxygen therapy Listed for lung transplantation NSAIDs, other than aspirin Hormone replacement therapy Hormonal contraceptives Anti-VEGF drugs NOAC



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Eligible for participation in the study patients must fulfill ALL the inclusion criteria and NONE of the exclusion criteria that are listed below and must be consecutively enrolled:

  • Newly diagnosed (less than 6 months) or patients previously diagnosed with IPF (more than 6 months from baseline visit), based upon the consensus statement jointly issued by ATS/ERS/JRS/ALAT in 2011

    • Exclusion of other known causes of ILD (e.g., domestic and occupational environmental exposures, connective tissue disease, and drug toxicity)
    • Assessment of IPF based on HRCT or combinations of HRCT and surgical lung biopsy, if available
  • Age ≥40 years old at the time of inclusion
  • Written informed consent for participation in the registry
  • Patients that can be followed up further, during the scheduled study period

None of the following Exclusion Criteria should be fulfilled:

  • Expected lung transplantation within the following 6 months
  • Participation in clinical trials
Criteria

Inclusion criteria:

  • Newly diagnosed (less than 6 months) or patients previously diagnosed with IPF (more than 6 months from baseline visit), based upon the consensus statement jointly issued by ATS/ERS/JRS/ALAT in 2011 (see Annexes 6 and 7 for HRCT and histological criteria in Annex 6)

    • Exclusion of other known causes of ILD (e.g., domestic and occupational environmental exposures, connective tissue disease, and drug toxicity)
    • Assessment of IPF based on HRCT or combinations of HRCT and surgical lung biopsy, if available
  • Age =40 years old at the time of inclusion
  • Written informed consent for participation in the registry
  • Patients that can be followed up further, during the scheduled study period

Exclusion criteria:

  • Expected lung transplantation within the following 6 months
  • Participation in clinical trials

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): NCT03074149


Contacts
Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Greece
Gen. Hosp. of Chest Diseases "Sotiria", Univ. Resp. Med. Recruiting
Athens, Greece, 11527
Contact: Demosthenes Bouros    +30 210 7763559    debouros@gmail.com   
Sotiria Hospital Athens, 7th Pulmonary Clinic Recruiting
Athens, Greece, 11527
Contact: Likourgos Kolilekas    30-2107763306    lykol@yahoo.gr   
Attikon General University Hospital Recruiting
Athens, Greece, 12410
Contact: Spyros Papiris    6932646673    papiris@otenet.gr   
University Hospital of Heraklion, University Pulmonology Cl Recruiting
Heraklion, Greece, 71100
Contact: Aikaterini Antoniou    6972300105    kantoniou@med.uoc.gr   
Univ. Gen. Hosp. of Larissa Recruiting
Larissa, Greece, 41110
Contact: Zoe Daniil    6945754663    zdaniil@med.uth.gr   
A Pulmonology Clinic "G.Papanikolaou" Hospital Thessaloniki Recruiting
Thessaloniki, Greece, 57010
Contact: Aikaterini Markopoulou    30 69 72691496    markopoulouk@gmail.com   
General Hospital of Thessaloniki "G. Papanikolaou" Recruiting
Thessaloniki, Greece, 57010
Contact: Despoina Papakosta    +30 2313 307258    depapako@gmail.com   
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03074149     History of Changes
Other Study ID Numbers: 1199.252
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial