A multicentre, retrospective chart review study to describe the clinical profile of idiopathic pulmonary fibrosis (IPF) patients treated with nintedanib (OFEV®) in real-world practice in Spain (BROAD)

Study identification

• EU PAS number:
  EUPAS19384
• Study ID:
  32078
• Official title and acronym:
  A multicentre, retrospective chart review study to describe the clinical profile of idiopathic pulmonary fibrosis (IPF) patients treated with nintedanib (OFEV®) in real-world practice in Spain (BROAD)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  The present study has been designed to characterize IPF patients treated with nintedanib (OFEV®) with respect to their clinical profile based on real-world data from January 2016 in Spanish Pulmonology Services. The primary objective of the study is to describe the distribution of patients across different lung function categories (%FVC and DLCO serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation. Patients will be classified with regards to the FVC and DLCO serving as surrogates for severity: FVC:- Mild IPF: FVC > 70% predicted - Moderate IPF: FVC 50% to 70% predicted (*)- Severe IPF: FVC < 50% predicted (*) %FVC has been adapted from 55 to 50% to be aligned with nintedanib (OFEV®) clinical trials program. DLCO:- Mild IPF: DLCO >50% predicted- Moderate IPF: DLCO 35% to 50% predicted- Severe IPF: DLCO <35% predicted Non-interventional study based on medical charts of multiple centers, of IPF patients treated with nintedanib (OFEV®). Patients will be characterized at time of treatment initiation (cross-sectional design). IPF patients with a confirmed diagnosis of IPF, who initiated treatment with nintedanib from 01 January 2016, will be selected. Approximately 35 Pulmonology Services of Hospitals in Spain will be the basis for the study. The sites will be distributed across whole Spain and will be selected according to previous experience in clinical trials, named-patient program and access to nintedanib (OFEV®).The participating investigators will review all medical records of their IPF patient’s since 01 January 2016 and select all patients who initiated treatment with nintedanib (OFEV®) in the study period.
• Study status:
  Finalised

Research institutions and networks

Institutions

H VIRGEN DEL ROCIO

Multiple centres: 35 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 15/11/2016

Actual: 15/11/2016

Study start date

Planned: 29/09/2017

Actual: 23/10/2017

Data analysis start date

Planned: 26/03/2018

Actual: 07/06/2018

Date of final study report

Planned: 27/05/2019

Actual: 07/05/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

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