Incidence and Prevalence of Interstitial Lung Disease and their progressive fibrosing phenotypes in 6 European Countries (PERSEIDS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38521
• EU PAS number:
  EUPAS34861
• Study ID:
  38521
• Official title and acronym:
  Incidence and Prevalence of Interstitial Lung Disease and their progressive fibrosing phenotypes in 6 European Countries (PERSEIDS)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Denmark

  Finland

  Greece

  Norway

  Portugal
• Study description:
  Non-interventional, epidemiological, retrospective, site-level (aggregated data) study in 6 European countries (Belgium, Denmark, Finland, Greece, Norway and Portugal). The study will be performed in two phases, both of them based on existing data. The main research questions are: in Phase 1 to know the epidemiology (incidence rate and prevalence) of ILD, SSc and some specific ILD-subtypes by collecting aggregated data from 18 hospital databases, in Phase 2, to describe the prevalence of progressive phenotypes and UIP pattern among other (non-IPF) fibrosing ILD subjects by looking into 100 patient files and reviewing lung function, hospitalizations, oxygen use, deaths and imaging results during a 2-year (retrospective) period.
• Study status:
  Finalised

Research institutions and networks

Institutions

TFS HealthScience (TFS)

Sweden

Multiple centres: 14 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 15/01/2019

Actual: 15/01/2019

Study start date

Planned: 15/05/2019

Actual: 15/05/2019

Data analysis start date

Actual: 20/04/2020

Date of final study report

Actual: 09/12/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim International GmbH (BI)

Study protocol

Initial protocol

SSc_ILD_Epi_(BIN1029)_Protocol_Final_20190429 (002)_clean

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable