Observational, multicentre, prospective, real-world post-authorization safety study describing the achievement of nintedanib-associated DIArrhoea control after 12 weeks of follow-up in patients with idiopathic puLmonary FIBrosis (IPF) and progressive pulmonary fibrosis (other than IPF) in Spain: the DIALFIB study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106525
• EU PAS number:
  EUPAS106524
• Study ID:
  106525
• Official title and acronym:
  Observational, multicentre, prospective, real-world post-authorization safety study describing the achievement of nintedanib-associated DIArrhoea control after 12 weeks of follow-up in patients with idiopathic puLmonary FIBrosis (IPF) and progressive pulmonary fibrosis (other than IPF) in Spain: the DIALFIB study
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  This study aims to describe the proportion of patients that achieve diarrhoea control after 12 weeks of follow-up among patients with IPF and other PPF having a first episode of nintedanib-associated diarrhoea in real world settings in Spain. It is expected that the study findings would suggest potential alternatives to address this problem and guide future studies aiming to prove the effectiveness of anti-diarrhoea treatments in this population.
• Study status:
  Planned

Research institutions and networks

Institutions

Clinical Pharmacology Department, Area del Medicament, Hospital Clínic de Barcelona

Spain

Study timelines

Date when funding contract was signed

Planned: 05/06/2023

Actual: 05/06/2023

Study start date

Planned: 30/04/2024

Data analysis start date

Planned: 30/05/2025

Date of final study report

Planned: 28/11/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim Spain

Regulatory

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