Characteristics of IPF patients initiating nintedanib, pirfenidone or no antifibrotic treatment in the US

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30365
• EU PAS number:
  EUPAS30039
• Study ID:
  30365
• Official title and acronym:
  Characteristics of IPF patients initiating nintedanib, pirfenidone or no antifibrotic treatment in the US
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This retrospective database study aims to understand characteristics of Idiopathic Pulmonary Fibrosis (IPF) patients treated with nintedanib and pirfenidone, as well as patients who do not receive a prescription for an antifibrotic treatment. The primary objective is to describe and compare demographic, clinical, and other characteristics of IPF patients initiating nintedanib, pirfenidone, or not receiving prescription antifibrotic treatment. The secondary objective is to compare and contrast the probability of receiving nintedanib vs. pirfenidone and nintedanib or pirfenidone vs. untreated in IPF patients using baseline patient characteristics.
• Study status:
  Finalised

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 14/09/2018

Actual: 14/09/2018

Study start date

Planned: 04/12/2018

Actual: 04/12/2018

Date of final study report

Planned: 06/06/2019

Actual: 06/06/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Study protocol

Initial protocol

IQVIA BI IPF channeling AP_12182018_v2

Regulatory

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