Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000172

EU PAS number

EUPAS1000000172

Study ID

1000000172

Official title and acronym

DARWIN EU® - Characterising interstitial lung disease in Europe

DARWIN EU® study

Yes

Study countries

France
Germany
Spain
United Kingdom

Study description

Rationale and background
Interstitial lung disease (ILD) is a heterogenous group of respiratory disorders affecting the interstitium of the lungs. Drug-induced ILD are adverse drug reactions from a wide range of drugs, many of which can be life-threatening diseases. Measuring the incidence of ILD and characterisating its population in Europe may guide signal detection validation discussions for drug-induced ILD.

Research questions
What were the incidence, the characteristics and overall survival of patients diagnosed with ILD and ILD-subtypes in four European countries in the period 2010-2022?

Objectives
The objectives are to measure (i) the incidences of ILD, stratified by age, sex and calendar time (obj. 1); (ii) to characterise the patients with ILD in terms of age, sex, comorbidities, risk factors and concomitant medications (obj. 2); and (iii) to measure the survival rates of patients diagnosed with ILD stratified by age, sex and calendar time (obj. 3) in four European countries. These objectives will be investigated for ILD overall and as well for the two most common ILD subtypes (alveolitis,pneumonitis and lung fibrosis).

Research methods
Study design
Cohort study with population-level descriptive epidemiology and patient-level characterisation

Population
All patients in the databases newly diagnosed with ILD in the period 1st January 2010 to 31st December 2022 with at least 365 days of data visibility prior to the date of first ILD diagnosis.

Variables
Condition of interest
ILD and ILD-subtypes (pulmonary fibrosis, alveolitis, pneumonitis,)

Study status

Ongoing
Research institution and networks

Institutions

Networks

Contact details

Katia Verhamme

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol

DARWIN EU_D2.2.3_Protocol_P3-C1-005_v2.1.pdf

English (1.18 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable