Clinical trial NCT03074149: Investigating Idiopathic Pulmonary Fibrosis in Greece
Official title: Investigating Idiopathic Pulmonary Fibrosis in Greece
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-03-08
Enrollment: 301
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

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

Eligibility 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

Primary outcomes:
measure: Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
timeFrame: At baseline visit and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.
measure: Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
timeFrame: 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.
measure: Number of Physician Contacts Per Patient by Study Visit
timeFrame: 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.
measure: Number of Visits in Outpatient Department by Study Visit
timeFrame: 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.
measure: Number of Visits in Pulmonologists by Study Visit
timeFrame: 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.
measure: Number of Visits in Other Physicians Than the Pulmonologists by Study Visit
timeFrame: 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.
measure: Number of Idiopathic Pulmonary Fibrosis (IPF) Related Procedures by Study Visit
timeFrame: 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.
measure: Number of Patients in Each Category of Hospitalizations by Study Visit
timeFrame: 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.
measure: Number of Patients in Each Category With Usage of Pirfenidone and Nintedanib
timeFrame: From signing the informed consent onwards until the end of the study, up to 24 months.
Secondary outcomes:
measure: Number of Patients in Each Category of Concomitant Medications
timeFrame: From signing the informed consent onwards until the end of the study, up to 24 months.
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Gen. Hosp. of Chest Diseases "Sotiria", Univ. Resp. Med.
city: Athens
country: Greece
facility: Sotiria Hospital Athens, 7th Pulmonary Clinic
city: Athens
country: Greece
facility: University General Hospital Attikon
city: Heraklion
country: Greece
facility: University Hospital of Heraklion, University Pulmonology Cl
city: Larissa
country: Greece
facility: General University Hospital of Larissa
city: Thessaloniki
country: Greece
facility: A Pulmonology Clinic "G.Papanikolaou" Hospital Thessaloniki
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "G. Papanikolaou"
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: