Investigating Idiopathic Pulmonary Fibrosis in Greece (INDULGEIPF)

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 301

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11527
    • Gen. Hosp. of Chest Diseases "Sotiria", Univ. Resp. Med.
  • Athens, Greece, 11527
    • Sotiria Hospital Athens, 7th Pulmonary Clinic
  • Athens, Greece, 124 62
    • University General Hospital ATTIKON
  • Heraklion, Greece, 71100
    • University Hospital of Heraklion, University Pulmonology Cl
  • Larissa, Greece, 41110
    • General University Hospital of Larissa
  • Thessaloniki, Greece, 57010
    • General Hospital of Thessaloniki "G. Papanikolaou"
  • Thessaloniki, Greece, 57010
    • A Pulmonology Clinic "G.Papanikolaou" Hospital Thessaloniki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Idiopathic Pulmonary Fibrosis (IPF) patients with less than 6 months diagnosis
Idiopathic Pulmonary Fibrosis (IPF) patients with equal or more than 6 months diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit	Number in each category of non-pharmacological treatment (e.g. start of Long-term oxygen therapy (LTOT), new listing for lung transplantation, physiotherapy) for Idiopathic Pulmonary Fibrosis (IPF) by study visit is reported. The categories of non-pharmacological treatment for Idiopathic Pulmonary Fibrosis (IPF) are the following: No; Yes; Unknown; Missing	At baseline visit and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit	Number of patients in each category of physician's clinical assessment of the probable course of IPF by study visit is reported. Physician's clinical rating of the probable course of IPF (stable, slow or rapid progression) was based on available Forced vital capacity (FVC) results, diffusion capacity for carbon monoxide (DLCO) results, physical examination, hospitalizations/events between the visits. The categories of physician's clinical assessment are the following: Stable disease; Slow progression; Rapid progression; No judgement possible; Missing	At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.
Number of Physician Contacts Per Patient by Study Visit	Number of physician contacts per patient is reported. For the baseline visit mean and standard deviation of physician contacts with the patient up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of physician contacts with the patient since the last study visit is reported.	At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.
Number of Visits in Outpatient Department by Study Visit	Number of visits in outpatient department by study visit is reported. For the baseline visit mean and standard deviation of visits in outpatient department up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of visits in outpatient department since the last study visit is reported.	At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.
Number of Visits in Pulmonologists by Study Visit	Number of visits in pulmonologists by study visit is reported. For the baseline visit mean and standard deviation of visits in pulmonologists up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of visits in pulmonologists since the last study visit is reported.	At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.
Number of Visits in Other Physicians Than the Pulmonologists by Study Visit	Number of visits in other physicians than the pulmonologists by study visit is reported. For the baseline visit mean and standard deviation of visits in other physicians than the pulmonologists up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of visits in other physicians than the pulmonologists since the last study visit is reported.	At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.
Number of Idiopathic Pulmonary Fibrosis (IPF) Related Procedures by Study Visit	Number of Idiopathic Pulmonary Fibrosis (IPF) related procedures by study visit is reported. For the baseline visit mean and standard deviation of Idiopathic Pulmonary Fibrosis (IPF) related procedures up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of Idiopathic Pulmonary Fibrosis (IPF) related procedures since the last study visit is reported.	At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.
Number of Patients in Each Category of Hospitalizations by Study Visit	Number of patients in each category of hospitalizations by study visit is reported. For the baseline visit number of patients in each category of hospitalizations up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months number of patients in each category of hospitalizations since the last study visit is reported. The categories of hospitalization were: No; Yes; Unknown; Missing	At baseline up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.
Number of Patients in Each Category With Usage of Pirfenidone and Nintedanib	Number of patients in each category with usage of pirfenidone and nintedanib is reported. The categories for usage of pirfenidone and nintedanib are the following: Yes; No; Unknown; Missing	From signing the informed consent onwards until the end of the study, up to 24 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients in Each Category of Concomitant Medications	Concomitant medication was defined as any treatment presented following the Informed Consent Form (ICF) signature. If stop date was missing in the electronic Case Report Form (eCRF), medication was considered as concomitant. The number of patients in each category of the following concomitant medications is reported. The concomitant medications are: Corticosteroids; N-Acetylcysteine; Azathioprine; Cyclophosphamide; Cyclosporine A; Other immuno-suppressant; Anticoagulants; Gastroesophageal reflux disease (GERD) medication; Phosphodiesterase type 5 (PDE-5) inhibitor; Endothelin receptor antagonist; Non-steroidal anti-inflammatory drugs (NSAIDs) other than aspirin; Hormonal contraceptives; Hormone replacement therapy; Anti-vascular endothelial growth factor (VEGF) drugs; Other (other than listed above) The categories for each concomitant medication listed above are the following: Yes; No; Unknown; Missing	From signing the informed consent onwards until the end of the study, up to 24 months.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: 1199.252

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

• IPD Sharing Time Frame: After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• IPD Sharing Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data- 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No