Investigating Idiopathic Pulmonary Fibrosis in Greece

NCT03074149 | Completed Results

• 1 other identifier: 1199.252
• Study Type: observational
• Target: 301
• Locations: 1 country
• Sites: 7

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (1)

• Number of Patients in Each Category of Concomitant Medications

  From signing the informed consent onwards until the end of the study, up to 24 months.

Study Arms (2)

Idiopathic Pulmonary Fibrosis (IPF) patients with less than 6 months diagnosis

Idiopathic Pulmonary Fibrosis (IPF) patients with equal or more than 6 months diagnosis

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)
• Assessment of IPF based on HRCT or combinations of HRCT and surgical lung biopsy, if available
• Written informed consent for participation in the registry
• Patients that can be followed up further, during the scheduled study period

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (7)

Gen. Hosp. of Chest Diseases "Sotiria", Univ. Resp. Med.

Athens, 11527, Greece

Location

Sotiria Hospital Athens, 7th Pulmonary Clinic

Athens, 11527, Greece

Location

University General Hospital Attikon

Athens, 124 62, Greece

Location

University Hospital of Heraklion, University Pulmonology Cl

Heraklion, 71100, Greece

Location

General University Hospital of Larissa

Larissa, 41110, Greece

Location

A Pulmonology Clinic "G.Papanikolaou" Hospital Thessaloniki

Thessaloniki, 57010, Greece

Location

General Hospital of Thessaloniki "G. Papanikolaou"

Thessaloniki, 57010, Greece

Location

Related Links

• Related Info

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: March 8, 2017
• Study Start: April 4, 2017
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: October 5, 2022
• Results First Posted: October 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

GR (7)