Evidence in real world for Trixeo® Aerosphere™ Initiation in COPD (ENARXI)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106901
• EU PAS number:
  EUPAS106900
• Study ID:
  106901
• Official title and acronym:
  Evidence in real world for Trixeo® Aerosphere™ Initiation in COPD (ENARXI)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The main aim of the study is to describe the characteristics of COPD patients when Trixeo® Aerosphere™ is initiated, based on data from the THIN® and Colibri databases. Secondary objectives are: - To describe from THIN® database data the rate of appropriate initiation of Trixeo® Aerosphere™ according to: - The Transparency Commission (CT) (18); - SPLF 2021 (5) and GOLD 2021 (4) recommendations. - To describe from THIN® database data the distribution of blood eosinophil count in patients initiating Trixeo® Aerosphere™. - To describe the characteristics of COPD patients initiating treatment with Trixeo® Aerosphere™ using data from the Colibri-BPCO cohort to compare the results obtained with THIN® data and supplement them with patients seen mainly by hospital and private lung specialists and potentially more severe.
• Study status:
  Ongoing

Research institution and networks

Institutions

Cegedim Health Data (CHD)

France

Study timelines

Date when funding contract was signed

Actual: 01/07/2021

Study start date

Actual: 01/09/2021

Date of final study report

Planned: 31/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable