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

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ClinicalTrials.gov Identifier: NCT03074149
Recruitment Status : Active, not recruiting
First Posted : March 8, 2017
Last Update Posted : May 14, 2019
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


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Study Type : Observational
Actual Enrollment : 301 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



Information from the National Library of Medicine

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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


Locations
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Greece
Gen. Hosp. of Chest Diseases "Sotiria", Univ. Resp. Med.
Athens, Greece, 11527
Sotiria Hospital Athens, 7th Pulmonary Clinic
Athens, Greece, 11527
University General Hospital Attikon
Athens, Greece, 124 62
University Hospital of Heraklion, University Pulmonology Cl
Heraklion, Greece, 71100
General University Hospital of Larissa
Larissa, Greece, 41110
A Pulmonology Clinic "G.Papanikolaou" Hospital Thessaloniki
Thessaloniki, Greece, 57010
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, Greece, 57010
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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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: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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