N/A
N=301
Investigating Idiopathic Pulmonary Fibrosis in Greece
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT03074149 ↗Enrolled (actual)
301
Serious AEs
9.6%
Results posted
Oct 2022
Primary outcome: Primary: Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit — 83; 162; 13; 43 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit |
83; 162; 13; 43; 0; 0 | — |
| PRIMARY Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit |
79; 158; 13; 41; 2; 3 | — |
| PRIMARY Number of Physician Contacts Per Patient by Study Visit |
3.651; 0.801; 0.676; 1.105; 0.778; 0.553 | — |
| PRIMARY Number of Visits in Outpatient Department by Study Visit |
2.844; 0.545; 0.502; 0.856; 0.664; 0.489 | — |
| PRIMARY Number of Visits in Pulmonologists by Study Visit |
3.027; 0.654; 0.624; 0.928; 0.698; 0.479 | — |
| PRIMARY Number of Visits in Other Physicians Than the Pulmonologists by Study Visit |
1.056; 0.34; 0.358; 0.561; 0.588; 0.505 | — |
| PRIMARY Number of Idiopathic Pulmonary Fibrosis (IPF) Related Procedures by Study Visit |
2.638; 1.216; 1.271; 1.722; 1.613; 1.569 | — |
| PRIMARY Number of Patients in Each Category of Hospitalizations by Study Visit |
83; 183; 13; 22; 0; 0 | — |
| PRIMARY Number of Patients in Each Category With Usage of Pirfenidone and Nintedanib |
33; 87; 54; 114; 0; 0 | — |
| SECONDARY Number of Patients in Each Category of Concomitant Medications |
11; 21; 73; 175; 0; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03074149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.